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Impaction Bone Grafting in Revision Arthroplasty

edited by

Christian DeIIoye
Universite Catholique de Louvain Brussels, Belgium

Gordon Bannister
Southmead Hospital Bristol, England

MARCEL

MARCEL DEKKER, INC.


DEKKER

NEWYORK BASEL

Although great care has been taken to provide accurate and current information, neither the author(s) nor the publisher, nor anyone else associated with this publication, shall be liable for any loss, damage, or liability directly or indirectly caused or alleged to be caused by this book. The material contained herein is not intended to provide specific advice or recommendations for any specific situation. Trademark notice: Product or corporate names may be trademarks or registered trademarks and are used only for identification and explanation without intent to infringe. Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress. ISBN: 0-8247-4799-2 This book is printed on acid-free paper. Headquarters Marcel Dekker, Inc., 270 Madison Avenue, New York, NY I00 16, J.S.A. tel: 2 12-696-9000; fax: 2 12-685-4540 Distribution and Customer Service Marcel Dekker, Inc., Cimarron Road, Monticello, New York 12701 U.S.A. tel: 800-228- 1 160; fax: 845-796- 1772 Eastern Hemisphere Distribution Marcel Dekker AG, Hutgasse 4, Postfach 8 12, CH-400 1 Basel, Switzerland tel: 41 -6 1-260-6300; fax: 41-61-260-6333 World Wide Web http://www.dekker.com The publisher offers discounts on this book when ordered in bulk quantities. For more information, write to Special Sales/Professional Marketing at the headquarters address above. Copyright 02004 by Marcel Dekker, Inc. All Rights Reserved. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage and retrieval system, without permission in writing from the publisher. Current printing (last digit): 10 9 8 7 6 5 4 3 2 1 PRINTED IN THE UNITED STATES OF AMERICA

CONTENTS

1.

The History of the Use of Bone Impaction Grafting in Primary and Revision Total Hip Arthroplasty Tom J. J. H. Slooff I. II. III. Introduction Bone Banking Bone Grafts Combined with Total HIP Replacement References

1 1 4 6 9

2.

Harvest, Storage, and Microbiological Security of Bone Allografts Christian Delloye, B. Naets, Nathalie Cnockaert, and Olivier Cornu I. II. III. IV. V. VI. VII. VIII. IX. X. XI. Introduction Donor Selection Bone Retrieval Risk of Viral Transmission Bacterial Transmission Risks Processing Preservation Sterilization From Femoral Head to Bone Morsel Record Keeping Conclusions References

11 11 12 13 14 15 15 16 17 18 18 20 20

3.

The Procurement, Processing, and Preservation of Allograft Bone Stephan Vehmeijer and Rolf M. Bloem I. II. III. IV. V. Introduction Allograft Procurement Disease Transmission Processing Methods Preservation Techniques

23 23 23 24 25 28
v

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Contents

VI. 4.

Recommendations References

29 29 33 33 34 36 36 39 39 41 41 42 44 50 53 53 57 57 57 58 59 67 68 72 72 75

Conserving Stocks in the Bone Bank David Finlayson and Philip Henman I. II. III. IV. V. Introduction Availability of Bone Identication of Potential Donors Alternative Donation Sites Summary of Recommendations References

5.

Mechanical Considerations in Impaction Bone Grafting: The Nijmegen Experience N. Verdonschot, S. B. Bolder, Pieter Buma, and B. Willem Schreurs I. II. III. IV. V. Introduction Inherent Mechanical Characteristics of Morselized Particles Application to the Acetabular Side Application to the Femoral Side Conclusions References

6.

Impaction Bone Grafting: A Mechanical Appraisal with Reference to Soil Engineering Douglas Dunlop I. Introduction II. Basic Science III. Grading IV. Mechanical Shear Testing V. Results VI. Discussion VII. Summary References

7.

Stability of Impaction-Grafted Hip and Knee Prostheses: Surgical Technique, Implant Design, and Graft Compaction Jan Herman Kuiper, James Richardson, Ayman Soliman, and Kevin Cheah I. II. III. IV. Introduction In vitro Sawbone Experiments Why is Graft Compaction Important? Discussion

75 76 84 89

Contents

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Acknowledgments References 8. Preparation of the Femoral Head Prior to Milling: Does Inclusion of the Articular Cartilage Inuence Impaction? An In Vitro Study with Human Femoral Heads Ashit Bavadekar, Olivier Cornu, Bernard Godts, Christian Delloye, Xavier Banse, and John Van Tomme I. Introduction II. Materials and Methods III. Results IV. Discussion Acknowledgments References 9. Impaction Bone Grafting with Processed Freeze-Dried Allografts: Evolution of the Compactness and Stiffness During Impaction Olivier Cornu, Ashit Bavadekar, Bernard Godts, Christian Delloye, Xavier Banse, and John Van Tomme I. II. III. IV. Introduction Materials and Methods Results Discussion Acknowledgments References

92 93

95

95 96 100 103 106 106

109

109 110 114 116 118 118 121 122 123 123 124 125 125 126 126 133 134

10.

Bone Graft Substitutes for Impaction Grafting Ashley W. Blom and Ian D. Learmonth I. II. III. IV. V. VI. VII. VIII. IX. Xenograft Polymethylmethacrylate (Bone Cement) Calcium Sulfate (Plaster of Paris) Glass-Ionomer Ceramics Polyhydroxy Acids Collagen Matrix Coralline-Derived Hydroxyapatite Absorbable Ceramics Summary and Discussion References

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Contents

11.

The Contribution of Synthetic Bone Grafting Material to Impaction Douglas Dunlop I. II. III. IV. V. VI. Introduction Mechanical Aspects Biological Aspects In vitro Modeling In vivo Modeling Summary References

141 141 142 142 143 143 151 151

12.

Comparative Dynamic Loading of Paired Femurs: Comparison of Freeze-Dried Versus Fresh-Frozen Bone Allografts Bernard Godts, Ashit Bavadekar, Olivier Cornu, M. Verhelpen, and Christian Delloye I. Introduction II. Materials and Methods III. Results IV. Discussion V. Conclusion References

157

157 158 166 169 173 174

13.

The Inuence of Particle Size at the Femur: Is Morsel Size a Critical Parameter? Does It Inuence the Stiffness of the Impacted Layer? Ashit Bavadekar, Olivier Cornu, Bernard Godts, Christian Delloye, Xavier Banse, and John Van Tomme I. Introduction II. Materials and Methods III. Results IV. Discussion References

177

177 178 182 184 185 187

14.

Mechanical Studies of the Bone Particle Size at the Femur Akio Kobayashi, Hirotsugu Ohashi, Yoshinori Kadoya, and Yuji Tanabe I. II. III. Introduction Study 1 Study 2

187 188 195

Contents

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IV. 15.

Discussion References

201 202 205 205 208 208 211 212 213 214 216 218 219 219 225 225 225 226 231 232 235 238 241 241 242 245 251 253 257 257 259

Impaction Grafting: How Does It Work? Magnus Tagil and Per Aspenberg I. II. III. IV. V. VI. VII. VIII. IX. X. Introduction Hypotheses Impaction and Ingrowth Immunogenicity Fracture Surface and Endogenous Proteins Impaction and Exogenous Growth Factors Bone Remodeling in Response to Load The Fate of the Impacted Graft During Remodeling Is Remodeling Necessary? Conclusions References

16.

Human Bone Histology After Morselized Cortico-Cancellous Bone Impaction Gosta Ullmark I. II. III. IV. V. VI. Introduction Biomechanical Aspects Clinical and Radiological Results Healing of the Graft Bed Studied with PET Histology of Impacted Bone Graft Incorporation Discussion References

17.

Histological Evaluation of Impaction Bone Grafting in Humans and Animals Pieter Buma, Sanne van der Donk, and B. Willem Schreurs I. II. III. IV. Introduction Material and Methods Results Discussion References

18.

Biological Enhancement of Bone Graft Materials by Osteogenic Factors Stephen D. Cook and Robert L. Barrack I. II. Introduction Preclinical Evaluation of the OP-1 Implant

Contents

III. 19.

Discussion References

263 266 269 269 269 270 272 272 275 275 278 281 286 287 287 290 298 303 307 307 308 311 314 318 323 323 323 324

Adding Growth Factors to Impacted Grafts: A Good Idea that Might Be Bad Per Aspenberg I. II. III. IV. Introduction What Makes Impaction Successful? Warning Against Using Growth Factors Conclusion References

20.

Acetabular Bone Impaction Grafting: Classication of the Bone Stock Loss and Surgical Technique Jean W. M. Gardeniers, Tom J. J. H. Slooff, and B. Willem Schreurs I. Introduction II. X-change Technique and the AAOS Classication III. Surgical Technique References

21.

Long-Term Results of Acetabular Reconstruction Using Impaction Bone Grafting and a Cemented Cup B. Willem Schreurs, Jean W. M. Gardeniers, and Tom J. J. H. Slooff I. Introduction II. Clinical Results III. Discussion and Recommendations References

22.

Impaction Bone Technique at the Acetabular Side E. Winter I. II. III. IV. Introduction Materials and Methods Results Discussion References

23.

Impaction Bone Grafting on the Femoral Side A. J. Timperley, P. Kenny, and G. A. Gie I. II. III. The Exeter TechniqueIndications Preoperative Planning Positioning The Patient

Contents

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IV. V. VI. VII. VIII. IX. X.

Surgical Approach Preparation of the Graft Preparation of the Femur Impaction of the Graft Reduction and Closure Postoperative Management Lessons We Have Learned During Evolution of the Technique References

325 329 330 333 346 346 346 347

24.

Impaction Grafting of the Proximal Femur with Freeze-Dried Bone in Revision Arthroplasty A. Mazhar Tokgozoglu, Bulent Atilla, and Egemen Turhan I. II. III. IV. V. Introduction Surgical Technique The Hacettepe Experience Scintigraphic Study Discussion References

349 349 350 352 355 358 360 363

25.

Enmeshed Impacted Bone Allograft at the Femoral Side Henri Migaud, Christophe Chantelot, Francois Giraud, Christophe Jardin, and Antoine Duquennoy I. Introduction II. The Technique III. Clinical Data IV. Discussion References

363 365 372 373 374 377 377 380 381 381 388 394 394 395

26.

Impaction Bone Grafting at the Hip: A Clinical Review Mickey S. Cho, Michael T. Casnellie, and Seth S. Leopold I. Introduction II. History of Impaction Allografting III. Algorithm For Femoral Reconstruction IV. Surgical Approaches and Technical Pearls V. Problems and Complications of Impaction Allografting VI. Clinical Results of Impaction Allografting VII. Summary References

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Revision of Total Knee Arthroplasty by Impaction Bone Grafting Gary W. Bradley I. II. III. IV. V. Introduction Indications Technique Clinical Experience Conclusions References

399 399 400 401 409 413 414 417 417 417 420 421 423 423 424 430 433 436 439 439 439 441 441 441 441 442 442 442 443

28.

Revision Knee Arthroplasty with Impaction Bone Grafting Gosta Ullmark I. II. III. Biomechanical Aspect Surgical Method Results References

29.

Revision Knee Arthroplasty with Impaction I. C. Heyligers, E. H. van Haaren, and P. I. J. M. Wuisman I. II. III. IV. Introduction Material and Methods Results Discussion References

30.

Different Types of Biomechanical Tests on Morselized Grafts Xavier Banse I. II. III. IV. V. VI. VII. VIII. Contained Compression Test Biaxial Shear Test Triaxial Shear Test Axial Compression on Cup Shear on Cup Axial Compression on Stem Torsion on Stem Walking Simulation References

Index

CONTRIBUTORS

Per Aspenberg Linkoping University Hospital, Linkoping, Sweden, and Lund University Hospital, Lund, Sweden Bulent Atilla Turkey Xavier Banse Hacettepe University Faculty of Medicine, Hacettepe, Ankara,

Universite Catholique de Louvain, Brussels, Belgium Tulane University School of Medicine, New Orleans,

Robert L. Barrack Louisiana, U.S.A. Ashit Bavadekar Ashley W. Blom England

Universite Catholique de Louvain, Brussels, Belgium University of Bristol, Bristol Royal Inrmary, Bristol,

Rolf M. Bloem Reinier de Graaf Hospital, Netherlands Bone Bank Foundation, Delft, The Netherlands S. B. Bolder University Medical Center Nijmegen, Nijmegen, The Netherlands ALTA Orthopaedics, Santa Barbara, California, U.S.A.

Gary W. Bradley Pieter Buma lands

University Medical Center Nijmegen, Nijmegen, The Nether-

Michael T. Casnellie Texas, U.S.A. Christophe Chantelot Kevin Cheah

William Beaumont Army Medical Center, El Paso,

University Hospital of Lille, Lille, France

Springeld Hospital, Chelmsford, Essex, England


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Contributors

Mickey S. Cho U.S.A.

William Beaumont Army Medical Center, El Paso, Texas,

Nathalie Cnockaert Stephen D. Cook Louisiana, U.S.A. Olivier Cornu

Universite Catholique de Louvain, Bruxelles, Belgium Tulane University School of Medicine, New Orleans,

Universite Catholique de Louvain, Brussels, Belgium Universite Catholique de Louvain, Bruxelles, Belgium Southampton University Hospital NHST, Southampton,

Christian Delloye Douglas Dunlop England

Antoine Duquennoy David Finlayson

University Hospital of Lille, Lille, France

Raigmore Hospital, Inverness, Scotland University Medical Centre Nijmegen, Nijmegen, The

Jean W. M. Gardeniers Netherlands

G. A. Gie Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter Hospital, Exeter, United Kingdom Francois Giraud Bernard Godts University Hospital of Lille, Lille, France Universite Catholique de Louvain, Brussels, Belgium Vrije Universiteit Medical Center, Amsterdam, The

E. H. van Haaren Netherlands Philip Henman

Freeman Hospital, Newcastle upon Tyne, England Vrije Universiteit Medical Center, Amsterdam, The

I. C. Heyligers* Netherlands Christophe Jardin Yoshinori Kadoya

University Hospital of Lille, Lille, France Osaka City University Medical School, Osaka, Japan

*Current afliation: Atrium Medical Center, Herleen, The Netherlands.

Contributors

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P. Kenny Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter Hospital, Exeter, United Kingdom Akio Kobayashi Osaka City University Medical School, and Osaka Social Medical Center Hospital, Osaka, Japan Jan Herman Kuiper The Robert Jones and Agnes Hunt Orthopaedic and District Hospital, Oswestry, Shropshire, England and Keele University, Keele, Staffordshire, England Ian D. Learmonth England University of Bristol, Bristol Royal Inrmary, Bristol,

Seth S. Leopold University of Washington Medical Center, Seattle, Washington, U.S.A. Henri Migaud B. Naets University Hospital of Lille, Lille, France

Universite Catholique de Louvain, Bruxelles, Belgium Osaka City University Medical School, Osaka, Japan

Hirotsugu Ohashi

James Richardson The Robert Jones and Agnes Hunt Orthopaedic and District Hospital, Oswestry, Shropshire, England and Keele University, Keele, Staffordshire, England B. Willem Schreurs Netherlands Tom J. J. H. Slooff Netherlands University Medical Center Nijmegen, Nijmegen, The

University Medical Centre Nijmegen, Nijmegen, The

Ayman Soliman The Robert Jones and Agnes Hunt Orthopaedic and District Hospital, Oswestry, Shropshire, England Magnus Tagil Yuji Tanabe Lund University Hospital, Lund, Sweden Niigata University, Niigata, Japan

A. J. Timperley Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter Hospital, Exeter, United Kingdom

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Contributors

A. Mazhar Tokgozoglu Ankara, Turkey Egemen Turhan Ankara, Turkey Gosta Ullmark Sweden

Hacettepe University Faculty of Medicine, Hacettepe,

Hacettepe University Faculty of Medicine, Hacettepe,

Centre for Research and Development, Lanssjukhuset, Gavle,

John Van Tomme

Royal Military Academy, Brussels, Belgium University Medical Centre Nijmegen, Nijmegen, The

Sanne van der Donk Netherlands

Stephan Vehmeijer Leiden University Medical Centre, Netherlands Bone Bank Foundation, Leiden, The Netherlands M. Verhelpen Universite Catholique de Louvain, Brussels, Belgium University Medical Center Nijmegen, Nijmegen, The

N. Verdonschot Netherlands E. Winter

BG Unfallklinik, Tubingen, Germany Vrije Universiteit Medical Center, Amsterdam, The

P. I. J. M. Wuisman Netherlands

1
The History of the Use of Bone Impaction Grafting in Primary and Revision Total Hip Arthroplasty
Tom J. J. H. Slooff
University Medical Center Nijmegen Nijmegen, The Netherlands

I.

INTRODUCTION

Bone reconstruction with grafts has a long history in medical science and according to folklore goes back to ancient times. The miracle of the twin saints Cosmas and Damian represents the rst alleged bone and tissue transplant. The legend tells the history of a pious sexton, who was lying in the Roman Forum exhausted from the pain of bone cancer in his leg. In a dream, the twin brothers came to help him, removed his diseased leg, and transplanted the leg of a Moor who had just died. As the Moor had darker skin than the sexton, this miraculous event has been recorded as the miracle of the black leg. Owing to the success of the operation, the twin brothers were canonized, and over the years artists have brought many spectacular masterpieces depicting this story to life on canvas (see Fig. 1). The early literature records that in 1674 the Dutchman Anthonie van Leeuwenhoek [1] and Job van Meekeren [2] carried out excellent scientic work on bone grafting and physiology. Van Leeuwenhoek, a contemporary of Jan van Swammerdam and Reinier de Graaf, gained an international reputation from his research into microscopy and for producing the rst thorough description of the histological structure of bone. In a well-documented study published in 1668, van Meekeren, a surgeon from Amsterdam, described the rst bone graft. The graft was taken from the skull of a dog and used successfully to repair a traumatic defect in a soldiers skull. In this case, the graft material is known as a xenograft,
1

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Figure 1

History of Bone Impaction Grafting

which indicates bone donation from one species to another. An autograft refers to bone that is transplanted from one location to another within the same individual. In the tale of the Moor, the bone graft received by the sexton represents an allograft, because the bone was donated by a member of the same species. Through the centuries, the use of autografts and allografts in surgical practice has varied. In the eighteenth and nineteenth centuries, bone grafting was not an accepted surgical procedure; it was considered to be experimental with an unpredictable outcome. However, the technique was developed out of sheer necessity in clinical practice, and even today clinical expertise is more advanced than the basic science of the subject. At the end of the nineteenth century and the beginning of the twentieth century, the use of bone grafts was strongly stimulated by well-known surgeons, such as Ollier [3] from France, Macewen [4] from Scotland, Curtis [5] from the United States, and Barth [6], Lexer [7], and Axhausen [8] from Germany. Between 1947 and 1950, the laboratory scientists Bush [9] and Wilson [10] started to develop and to perfect preservation techniques, which led to the foundation of the National Naval Tissue Bank in Bethesda, Maryland. This made it possible to use allograft clinically on a much larger scale, particularly to replace bone lost traumatically or through tumor. Based on animal experiments and clinical observations, they observed that the graft, whether an autograft or an allograft, largely lost its vitality and then became revitalized from the host bone. Major components in this incorporation process were considered to be the periosteum tranplanted with the graft and the vascular network of the host. Herndon and Chase [11], Burwell [12], and Campbell [13] demonstrated an immune response in animals receiving allograft bone. They also concluded that freezing of bone reduced this. In 1953 Marshall Urist [14] developed the theories of osteoinduction and osteoconduction and introduced the bone morphogenetic protein that induces bone formation. Current knowledge about the use and the histological fate of a bone graft differs very little from the original ideas of the past, and Axhausens theory, originally presented in 1909, continues to be tenable. Today, it is generally accepted that graft incorporation, whether autogenic or allogenic, represents a sequence of events that reects a partnership between graft- and host-derived factors. The host contributes all the blood vessels and most of the cells required for the repair process. The graft itself serves mainly as a scaffold on which the host response occurs. The graft matrix with the growth factors and the residual cells promote host cellular activity, which is required for bone formation. Other important concomitant factors that inuence the biology of graft incorporation are: The origin of the tissue (autograft-allograft) The type of tissue (cortical-cancellous)

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The The The The The

size of the graft (large and small fragment grafts) preservation method (fresh-frozen, freeze-dried) stability of xation loading pattern of the graft vascularity of the host bed

From animal experiments [15,16] and clinical experience [17], we know that cortical allografts incorporate slowly, unevenly, and incompletely because of the density of the structure. In contrast, cancellous grafts contain large marrow spaces, permitting rapid and even revascularization and new bone formation without mechanical weakening of the graft during incorporation. Cancellous allograft can be used as structural or morselized bone and is generally indicated in situations where the highest osteogenic capacity is required. There is also a difference in the process of incorporation between a structural and a morselized cancellous allograft. Structural cancellous grafts generally have cystic lesions because of the degenerative process in the femoral head. They contain large amounts of fatty marrow tissue that may decrease incorporation. Clinical studies of massive structural trabecular allografts used in revision and tumor surgery have shown that their incorporation is often conned to the outer few millimeters, leaving a central necrotic core, which eventually causes failure of the graft. We also observed that during a slow and incomplete incorporation process, maintaining sufcient stability of the graft to the host bone is difcult to achieve in a weight-bearing part of the hip. Obviously, the difference in the biological behavior of the various grafts will affect their mechanical properties. It is well known that an individuals own bone, as an autograft, incorporates better than allograft, owing to the high osteogenic capacity and the absence of immune response. However, it is not always possible to harvest sufcient quantity of autograft, and it is often of poor quality. Furthermore, the additional incision necessary to harvest the bone causes additional morbidity and necessitates the use of bank bone.

II.

BONE BANKING

After the Second World War, American researchers and surgeons showed increasing interest in bone grafting. This led to the foundation of the rst bone bank, the National Naval Tissue Bank, in Bethesda, Maryland. The bone bank was responsible for acquiring, processing, storing, and distributing of tissue and organs for transplantation. This was done according to the guidelines of the American Association of Tissue Banks to guarantee the safety and predictable biological and mechanical properties of the material issued. The banks had to supply bone that was free from any possible disease and abnormalities that might

History of Bone Impaction Grafting

endanger the health of the recipient. In order to guarantee this, various factors, such as donor selection, consent, sterile harvesting, processing, storage, distribution, and documentation, formed important aspects that had to comply with high-quality requirements. In Europe this development started later and more slowly. Through private initiative, requests from clinical practice and surgical experience, hospital bone banks were set up at a few Dutch orthopedic departments in the 1960s. Their simple design comprised a domestic chest deep freezer with a minimum temperature of 2208C, in which the bone was stored. In those days, our bank, containing cadaveric bone, was run by an orthopedic resident with special interest and supervised by the nursing staff from the operating theater. Between 1964 and 1980, the bone, which was acquired in limited quantities from fatally injured trauma patients, was chiey used in major spinal fusions in children, in adults with posttraumatic nonunion, and for defects after resection of bone tumors. In the 1980s, more donor bone became available because of the femoral heads that were removed during primary total hip replacements. After careful selection and screening of these living donors, each femoral head was deep frozen at 2208C and kept for a maximum of 6 months. No microbiological cultures were taken during this period, but aerobic and anaerobic cultures were taken when the donor bone was harvested and at a later stage during the bone grafting procedure. Over the past few years, the guidelines for donor screening have become more stringent, because we are more aware of the possible transmission of infectious, particularly viral, diseases via the bone graft. In addition, extensive laboratory examinations of blood and bone tissue have been introduced in order to adequately exclude viral infections such as human immunodeciency virus (HIV) and hepatitis. If there is the slightest doubt about bacterial or viral contamination during the whole procedure of harvesting, processing, and preservation, the bone is destroyed. To reduce the risk of infection and virus transmission, some countries recommend additional sterilization by gamma irradiation, gas sterilization, or pasteurization. Because of the complexity of all these measures, more and more hospital bone banks have become incorporated by existing blood banks. With specialised and advanced techniques, such as freezedrying and deep-freezing to 2908C, these institutions store bone safely from carefully screened, deceased donors for fairly long periods of time. Obviously, special care must be taken during processing to preserve the characteristic biological and mechanical properties of both cortical and cancellous types of bone graft to facilitate subsequent clinical application. In clinical practice, a choice has to be made between cortical and cancellous graft. Cortical grafts can be used as solid and structural segments and are indicated if the stability of the surgical reconstruction needs to be increased, for example, to bridge bone defects in the cortical tubes or as onlay grafts in femoral

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revision surgery to bridge cortical defects. Cancellous bone may be used in structural or morsellized form and is indicated in situations where the highest osteogenic capacity is required, such as lling cavitary and contained segmental defects encountered in revision of failed total hip replacements.

III.

BONE GRAFTS COMBINED WITH TOTAL HIP REPLACEMENT

In the 1970s, a new application for bone grafting was introduced for the reconstruction of acetabular defects in primary and revision total hip arthroplasty. In primary total hip replacement, an acetabular defect was often congenital, resulting in a peripheral, segmental acetabular rim defect. A primary cavitary defect was seen fairly commonly at an advanced stage of rheumatoid arthritis. This defect is usually described as protrusio acetabuli. In revision surgery, the defect is caused by bone lysis, which causes cavitary, segmental, or combined defects of the acetabulum. In 1975, Hastings and Parker [18] published their rst experience with autologous cancellous bone fragments with a cemented total hip prosthesis in protrusio acetabuli caused by rheumatoid arthritis. The thin medial wall was left intact, was not reamed, and autogenous cancellous graft with cement was used to lateralize the socket. This was supported with a coarse Vitallium mesh cup with a narrow rim to spread the load peripherally. Harris et al. [19] were the rst to use femoral heads as a structural corticocancellous graft, xed to the pelvis with screws and bolts, in 38 primary acetabular reconstructions. The indication for this surgical reconstruction was the superior segmental acetabular defect in congenital dysplasia. This technique remained popular for several years and was widely adopted in primary and revision surgery. Harris started to use this technique in 1977 with both cemented and cementless components. In 1990, after an intermediate 6-year follow-up, the pioneers [20] of this popular technique reported that structural grafts were only a short-term solution, and in 1993 [21] they published further reservations about structural weight-bearing allografts. Although Hastings and Parker reported favorable results in their series, Coventry [22], in 1978, was pessimistic about graft viability. In primary arthroplasties, he preferred to resect the femoral head from the neck, leave it in situ in the acetabulum as a structural graft, and impact three dowel grafts into the head/acetabular interface. The base of the xed head and neck was then prepared as for a normal acetabulum. In 1978, McCollum and Nunley [23] reported their rst experience with bone grafting of acetabular protrusion. Their series started in 1968. They used a 1 cm thick slice from a frozen femoral head as a structural allograft in combina-

History of Bone Impaction Grafting

tion with a Smith Petersen cup. After 1971 they supplemented total hip replacement with mostly autogenous bone grafting of the medial wall of the acetabulum. Their series included 23 patients with acetabular protrusio and 2 with failed primary total hip replacement. Their technique comprised drilling holes in the ischium, ilium, and pubis. Then a slice of bone 1 cm thick was fashioned to t the central defect or the inner wall if there was no segmental defect. The structural graft was then coated or overlaid with Gelfoam to prevent cement from coming into contact with the bone graft. The graft was held in place by overlying ne Vitallium mesh tucked into the holes with an impactor. An Eichler ring was inserted followed by a cemented polyethylene socket. In 1983, Marti and Besselaar [24] introduced a technique for protruded and dysplastic acetabuli. Medial segmental defects were closed with a structural cortico-cancellous graft and supplemented with autogenous chips. Intact acetabular host bone was compressed with an impactor for cement xation and reinforced with an Eichler ring. The peripheral segmental defects were repaired with iliac crest grafts xed with screws to the ilium. In 1983, Roffmann et al. [25] investigated the fate of autogenous bone graft chips under a layer polymethylmethacrylate (PMMA) cement in an animal model with intrapelvic protrusio. Their model comprised an acetabular defect. Histological examination revealed that new bone grew from the acetabular wall into the graft. The graft appeared viable, and new bone formed at the bone/cement interface. After 10 months, solid bony union had been established between the acetabulum and graft with complete incorporation. Based on these experimental results in dogs, Mendes et al. [26] published the results of a clinical study on primary cemented arthroplasties with autogenous bone fragments supported by metal mesh for acetabular protrusion with good clinical results up to 6 years. Since the late 1970s, impaction bone grafting with cemented total hip arthroplasty has been our treatment of choice for restoring acetabular bone stock. We modied the techniques developed by Hastings and Parker and McCollum et al. and published our clinical experience [27] in 1984. The main modication we made to their techniques was the use of larger fragments of fresh deep-frozen trabecular bone, vigorous impaction of the graft fragments, and direct contact of cement on graft. Support rings were not used, and we relied instead on the stability of the cement-graft reconstruction. It was important to convert segmental, non-contained defects into cavitary defects with exible metal mesh. This stabilized the graft during impaction. In the course of time, various modications of the Nijmegen Bone Grafting Technique were introduced with cementless implants, structural or undersized cancellous grafts, and metal reinforcement. Other methods were developed to cope with extensive loss of bone stock. Decient bone stock was replaced by larger implants, more bone cement, and implants with coatings to promote spontaneous bone growth.

Slooff

Orthopedic oncology has had many years of experience with massive and structural bone grafting with special mega-prostheses for patients requiring femoral reconstruction. In this specic group of patients, the clinical results were moderate but acceptable. Incomplete and unpredictable incorporation of the graft was the main problem, resulting in fracture or resorption of bone graft. In emergency situations, this combination of structural, massive allografts and hip prostheses is still employed. In the 1980s, the majority of femoral revisions after failed total hip arthroplasty were performed with long stem components that bridged the proximal defect and were xed into the distal part of the shaft with bone cement, or by press-t prostheses with an osteoconductive surface nish. At our clinic, we initially chose a conventional femoral component with a larger diameter in combination with a larger quantity of bone cement. Clinical success was short-lived and, just as on the acetabular side, a defect remained a defect after recementing. All these older techniques sought a mechanical solution to restoring the defect. Less attention was paid to a biological solution for the loss of cortical and cancellous bone of the femur. Encouraged by our favorable experience of acetabular reconstruction with tightly impacted morsellized allografts and cement, we developed a similar technique for femoral defects. From the mid1980s our rst cases were grafted without specialized instrumentation using trial stems to pack bone chips into localized femoral lytic lesions. At the same time this crude technique was also used in Exeter, independently of Nijmegen. From 1990, in close cooperation with Ling and Gie from Exeter and representatives of Howmedica International, femoral and acetabular instruments were developed that would guarantee a sleeve of tightly impacted bone chips in the enlarged medullary cavity and acetabulum (X-Change Revision Instrumentation System). The initial clinical experience with femoral reconstruction was reported in 1991 by Simon et al. [28], and in the same year, Schreurs et al. [29] showed increased stability of the femoral component obtained by combining impacted graft and cement experimentally. The choice of the specic double-tapered, polished, and collarless Exeter prosthesis was based on clinical analyses of total hip replacements at the Princess Elisabeth Orthopaedic Hospital, Exeter, and on the research from the School of Engineering of Exeter University [30]. In comparison with the many other prostheses available at that time, Exeter had 20 years of clinical experience with this type of stem. The Exeter prosthesis functions as a self-locking taper in the bone cement. Its special design, with a broad proximal part and a narrow distal part, is a unique way of transmitting stress into the bone cement and the femur. The polished surface minimizes wear particles, reduces detrimental axial shear stresses at the prosthesis/cement interface, and in this way protects the biological cement/bone interface. The stem is centered in the femoral shaft, which guarantees that it is completely surrounded by a layer of cement. These properties protect the bone bed from local osteolysis. Over 20 25 years, excellent, reliable,

History of Bone Impaction Grafting

and predictable results have been achieved with this prosthetic stem in primary cemented total hip replacement. There has been a low incidence of radiolucent lines at the cement/bone interface, minimal calcar resorption, and a very low incidence of endosteal bone lysis. The survival curves of this femoral component show a low failure rate for mechanical loosening. In conclusion, as shown often before in the history of bone grafting, the technique of impaction bone grafting was started when surgeons were confronted with severe bone stock defects in hip replacement. Based on good clinical results, laboratory research was started to study this reconstruction technique and understand the method. Detailed descriptions of acetabular reconstruction, postoperative treatment, and clinical results with impacted bone grafts are presented in Chapters 5, 20, and 21.

REFERENCES
1. 2. 3. 4. 5. 6. 7. 8. Leeuwenhoek van A. Microscopical observations about blood, milk bones, the brain, spittle, cuticula, sweet, fat and tears. Philes Trans R Soc Lond 1674; 9: 121 131. Meekeren van J. Heel- en geneeskundige aanmerkingen. Amsterdam: Commelijn, 1668. Ollier L. Traite experimental et clinique de la regeneration des os et de la production articielles du tissue osseux. Paris: Victor Masson et ls, 1867. Macewen W. Observations concerning transplantation of bones. Proc Soc Lond 1881; 32: 232 247. Curtis BF. Cases of bone implantation and transplantation for cysts of tibia, osteomyelitic cavities and ununited fractures. Am J Med Soc 1893; 106: 30 37. Barth A. Uber histologische Befunde nach Knochenimplantationen. Arch Klin Chir 1893; 46: 409 417. Lexer E. Die Verwendung der freien Knochenplastik nebst Versuchen uber Gelenkversteifung und Gelenktransplantationen. Arch Klin Chir 1908; 86: 939 954. Axhausen G. Arbeiten aus den Gebiet der Knochenpathologie und Knochenchir urgie. kritische Bemerkungen und neue Beitrage zur freien Knochentransplantationen. Arch Klin Chir 1911; 94: 241 281. Bush LF. The use of homogenous bone grafts. A preliminary report on the bone bank. J Bone Joint Surg 1947; 29A: 620 628. Wilson PD. Experience with the use of refrigerated homogenous bone. J Bone Joint Surg 1951; 33B: 301 315. Herndon CH, Chase SW. The fate of massive autogenous and homogenous bone grafts including articular surfaces. Surg Gyn Obstet 1954; 98: 273 290. Burwell RG, Gowland G. Studies in the transplantation of bone. The immune response of lymph nodes draining components of fresh homogenous bone treated by different methods. J Bone Joint Surg 1962; 44B: 131 148.

9. 10. 11. 12.

10 13. 14. 15. 16.

Slooff Campbell CJ. Experimental study of the fate of bone grafts. J Bone Joint Surg 1953; 35A: 332 346. Urist MR. Bone: formation by autoinduction. Science 1965; 150: 893 899. Goldberg VM, Stevenson S. Natural history of autografts and allografts. Clin Orthop 1987; 225: 7 17. Stevenson S, Xiao Qing Li, Martin B. The fate of cancellous and cortical bone after transplantation of fresh and frozen tissue-antigen-matched and mismatched osteochondral allografts in dogs. J Bone Joint Surg 1991; 73A: 1143 1157. Enneking WF, Mindell ER. Observations on massive retrieved human allografts. J Bone Joint Surg 1991; 73A: 1123 1142. Hastings DE, Parker SM. Protrusio acetabuli in rheumatoid arthritis. Clin Orthop 1975; 108: 76 84. Harris WH, Crothers O, Oh I. Total hip replacement and femoral head bone grafting for severe acetabular deciency in adults. J Bone Joint Surg 1977; 59A: 752 769. Jasty M, Harris WH. Salvage total hip reconstruction in patients with major acetabular bone deciency using structural femoral head allografts. J Bone Joint Surg 1990; 72B: 63 68. Kwong LM, Jasty M, Harris WH. High failure rate of bulk femoral allografts in total hip acetabular reconstructions at 10 years. J Arthroplasty 1993; 8: 341 347. Coventry MB. Preparation of the acetabulum for total hip arthroplasty. In: The Hip, Proceedings of the Sixth Open Scientic Meeting of The Hip Society. St. Louis: The C.V. Mosby Company, 1978: 113 124. McCollum DE, Nunley JA. Bone grafting in acetabular protrusio: a biologic buttress. In: The Hip, Proceedings of the Sixth Open Scientic Meeting of The Hip Society. St. Louis: The C.V. Mosby Company, 1978: 124 149. Marti RK, Besselaar PP. Bone grafts in primary and secondary total hip replacement. In: Marti RK, ed. Progress in Cemented Total Hip Surgery and Revision. Amsterdam: Excerpta Medica, 1983: 107 129. Roffmann M, Silberman M, Mendes D. Viability and osteogenity of bone coated with methylmethacrylate cement. Acta Orthop Scand 1982; 53: 513 519. Mendes D, Roffmann M, Silberman M. Reconstruction of the acetabular wall with bone graft in arthroplasty of the hip. Clin Orthop 1984; 186: 29 38. Slooff TJJH, Huiskes R, van Horn JR, Lemmens AJ. Bone grafting in total hip replacement for acetabular protrusio. Acta Orthop Scand 1984; 55: 593 596. Simon JP, Fowler JL, Gie GA, Ling RSM, Timperley AJ. Impaction cancellous grafting of the femur in cemented total hip revision arthroplasty. J Bone Joint Surg 1991; 73B: s73. Schreurs BW, Huiskes R, Slooff TJ. The initial stability of cemented and noncemented stems xated with a bone grafting technique. Orthop Trans 1991; 15: 439 440. Fowler JL, Gie GA, Lee ACJ, Ling RSM. Experience with the Exeter total hip replacement since 1970. Orthop Clin North Am 1988; 74: 1119 1129.

17. 18. 19. 20.

21. 22.

23.

24.

25. 26. 27. 28.

29.

30.

2
Harvest, Storage, and Microbiological Security of Bone Allografts
Christian Delloye, B. Naets, Nathalie Cnockaert, and Olivier Cornu
Universite Catholique de Louvain, Bruxelles, Belgium

I.

INTRODUCTION

Bone allografts have been used primarily for limb salvage procedures in orthopedic oncology. Tissue banks have made bone readily available, and this availability arose from the interest of surgeons treating more current bone loss such as that associated with implant loosening. Bone allografts became part of the reconstruction, and the need for banked bone has sharply risen with the spiraling increase in revision arthroplasty. In Belgium, a country of 10 million inhabitants, 15,000 primary hip and 10,000 knee arthroplasties are performed each year. With patients living longer and arthroplasty being performed in younger patients, revision arthroplasty for loose hip and knee prostheses has become a major part of current orthopedic practice. In Belgium, hip revision arthroplasties accounted for 12% of primary hip replacements in 2001. Most of these revisions are caused by wear particles that generate an unopposed osteolysis around the implant with progressive implant loosening. Restoration of a bone stock with a conventional implant is a standard approach to dealing with loose cemented implants. In the past, massive allografts were used [1,2], but these have been replaced by morselized impacted bone to reconstruct a stable joint. This chapter describes the current procedures used to select tissue donors, process bone, and preserve the grafting material.

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II.

DONOR SELECTION

Selection of a donor is one of the major responsibilities of a tissue bank because of the risk of disease transmission [3 5]. Because only unprocessed, fresh frozen allografts have been documented as sources of viral infection in bone graft recipients, efforts have been made to decrease this risk by processing the tissue whenever possible [6]. Tissue implantation is never an emergency and is an elective procedure. To reduce the risk, tissue banks perform donor screening through a battery of questions about the lifestyle and medical history of the potential donor and through a series of biological assays. To exclude donors at risk for disease transmission, several updated guidelines have been published, including those issued by the American Association of Tissue Banks (AATB) [7], the European Association of Musculoskeletal Transplantation (EAMST), and the European Association of Tissue Banks (EATB) [8]. The most important exclusion criteria are: Presence or suspicion of any dementia or any central nervous diseases such as Alzheimers or Creutzfeldt-Jakob diseases Risk factors for HIV or B or C hepatitis History of chronic hepatitis or presence of an active hepatitis History of extracted pituitary hormone History or suspicion or presence of HIV or HTLV infection History of malignant disease (basal cell carcinoma of the skin excluded) Presence of connective tissue disease (e.g., lupus, rheumatoid arthritis) or chronic steroid use Presence or evidence of infection or prior irradiation at the site of donation Unknown cause of death (without autopsy) Any donor of tissue will be screened using premortem blood sample by laboratory assays, including the following tests. The minimum serological tests are: Hepatitis B surface antigen (HBs-ag) Hepatitis B core antibody (HBc-ab) Hepatitis C virus antibodies (HCV) HIV1-2 antibodies Syphilis Optional blood tests that can be performed include the following: Polymerase chain reaction (PCR) for HIV, hepatitis viruses. When quarantine is not possible, a negative PCR for HIV and hepatitis C might be accepted if properly performed by an experienced laboratory. HTLV 1-2 antibody (legal requirement in France, required also by AATB).

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13

Alanine aminotransferase (ALT) for a living donor (legal requirement in France). This last recommendation has been set for the detection of patients with liver disease and possibly a viral hepatitis. Rhesus factor, as it is known that a femoral head from a Rhesus-positive donor is able to sensitize a Rhesus-negative recipient [9,10]. Consequently, Rhesus matching is necessary for a Rhesus-negative female patient with childbearing potential. HLA histocompatibility group matching is unnecessary for successful allograft. Although bone allograft may elicit an immune response, its signicance has not been so far demonstrated [11,12]. Table 1 lists the various kinds of bone allografts.

Table 1 Source

Various Types of Bone Allografts Bone Femoral head Massive bone Bone Procedure Quarantine Quarantine via the testing of organ recipients tendons Premortem blood sample required (without hemolysis); no quarantine possible; validated tissue processing necessary

Living donor Organ donor Deceased donor

III.

BONE RETRIEVAL

Femoral heads are harvested from living donors during primary hip arthroplasty and larger bones recovered from organ donors. Consent for tissue retrieval is obtained according to the national law or regulation. If there is no applicable regulation, informed consent is obtained from the living donor and from the next of kin in case of organ donors. Bone recovery from a live donor is performed in aseptic conditions in an operating theater, whereas harvest from an organ donor can be made either in aseptic conditions or in a nonsterile but clean environment. In the latter case, secondary sterilization will be necessary, usually by irradiation. Contamination is assessed by culturing samples from the tissue immediately after retrieval. Any positive culture with a pathogenic microorganism is excluded. As bone has been shown to adsorb and release antibiotic [13,14], long bones from dead donors are immersed (after bacteriological screening) in

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1.2 g/L rifampicin solution for 45 minutes before nal packaging. This immersion is repeated at the thawing phase.

IV.

RISK OF VIRAL TRANSMISSION

The risk of a viral transmission through an allograft can occur; the world literature reveals that at least four recipients who received nonprocessed bone have been contaminated by the HIV virus [6,15] and that four others have been contaminated by hepatitis C virus [16]. The risk is associated with a seronegative window during which a virus-contaminated donor can transmit the virus while the serum remains negative. In 1989, the mean time to seroconvert from the time of exposure to HIV virus [17] was 42 days. Recent improvement of the sensitivity of HIV antibody assays has resulted in a signicant shortening of this preseroconversion window period. The time to seroconversion with the third-generation assay varies. When the screening was performed with antibody assay alone, Busch et al. [18] estimated the window period to be 22 days and Lelie et al. [19] 37 days. Assuming that there is a 10-fold higher incidence of HIV infection among tissue than blood donors, Lelie et al. estimated the risk of a window donation for a tissue to be 6 per million tissue donors (one per 166,000 donors). With a window of 14 weeks and an incidence of 610 per million tissue donors, the risk for a hepatitis C contaminated tissue would be 160 per million (one per 6,250 donors). The risk of a window donation can be lowered by additional safety measures.

A.

Use of Amplication Tests

The polymerase chain reaction is an in vitro amplication of a viral genome that might potentially be intercalated into the patients DNA. Because the selection and amplication of the target DNA is independent of antibody response, an infecting virus can be detected before seroconversion. This assay is very sensitive and specic. HIV-DNA polymerase chain reaction is able to shorten the average window period to 16 days from the day of exposure. The residual risk of an infectious tissue would be reduced to 1 in 230,000 donations. HIV p24 antigen testing has the same reduction as the HIV-DNA PCR on the window period. The European standards [8] recommend the use of PCR or p24 antigen testing for HIV and PCR for hepatitis C when tissue cannot be kept in quarantine.

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B.

Quarantine

The quarantine is a waiting period after which the living tissue donor is tested again, as is the recipient of the organ in case of an organ donor. This is the safest, the least expensive, and the most sensitive method of tracking hepatitis C and HIV viruses. As such, tissue should be quarantined whenever possible. In living donors, American [7] and European guidelines [8] recommended a 6-month quarantine period. This interval remains the same despite the increased sensitivity of HIV antibody assay because of the longer latency for hepatitis C virus. In organ donors, the 6-month quarantine can be 3 months shorter, as a contaminated vascularized organ should expose the recipient to a much earlier viral load [15]. Today, the theoretical risk of viral transmission of HIV is less than one in a million and for HCV, one in 200,000 in deep-frozen, nonirradiated, and unprocessed bone procured from a selected and serologically screened donor. This risk is further decreased for HIV virus to less than one in a billion after a 6-month quarantine and for HCV to one in 2 million. After validated tissue processing, this risk is virtually eliminated.

V.

BACTERIAL TRANSMISSION RISKS

The risk of tissue transmission of pathogenic microorganisms is rare, but it has occurred. Very recently, the U.S. Centers for Disease Control (CDC) reported 54 cases of allograft-associated infections, of which half were from one U.S. tissue bank [20]. This sudden increase appears to result from poor compliance with good tissue practices, such as inadequate testing of incoming tissue and failure to assess the degree of bacterial contamination of tissues immediately after harvesting. This further emphasizes the importance of rigorous bacterial screening before and after tissue processing.

VI.

PROCESSING

Processing means any activity performed on tissue other than the tissue recovery. It includes steps to inactivate and remove harmful agents. One of the purposes of processing is shaping the graft material for its future use (bone morsels, dowel, threaded cages, etc). Processing also allows decontamination of the tissue by eliminating bone marrow and cellular debris [21] with uids and detergents. The standard of decontamination should be conrmed by validated methods before routine use.

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Processing also improves the osteoconductive capacity in experimental comparisons of marrow-free and marrow-containing bone [21]. Elimination of marrow seems also to extract peroxidated lipids from irradiated bone. These marrow by-products seem to be cytotoxic to cultured osteoblasts [22]. Solvent detergents such as chloroform, ethanol, acetone, and ether are often used. These chemical agents are able to inactivate coated viruses such as HIV and hepatitis B and C [23]. Hydrogen peroxide has been long used as a bleaching agent and is also effective against viruses and bacteria due to its capacity to form free radicals. For transmissible spongiform encephalopathy (TSE) associated prions, transmission through musculoskeletal tissue has not been demonstrated so far. There are today two chemical treatments recognized as effective against TSE-associated prions by the World Health Organization (WHO) [24]: sodium hydroxide 1 M for 1 hour at 208C or sodium hypochlorite (2% chlorine available) for 1 hour at 208C. However, there is no adequately validated method for these TSE-associated prion decontamination procedures. Water jet lavage is a physical method that may effectively decontaminate tissue with one decimal reduction [25]. Another option is supercritical CO2 at high pressure (280 bars) and at 508C for deep cleansing of bone fat [26]. The main advantage of this approach is that the power of penetration is not limited by the size of the tissue. Other banks use a wide range of uid pressure to thoroughly eliminate particles and cellular material from tissue.

VII.

PRESERVATION

There are two widely used preservation methods: deep-freezing and freezedrying. Deep-freezing is achieved by placing the tissue either in a 2808C mechanical freezer or in liquid nitrogen at 21968C. From mechanical and immunological viewpoints, there are no differences between both temperatures, and deep-freezing has no detrimental effects on the original mechanical properties of bone [11]. Freeze-drying will result in a dried material that can be kept at room temperature. It contains less than 5% (w/w) of residual moisture [27]. Compared to a deep-frozen bone, freeze-dried tissue does not elicit a humoral immune response. However, freeze-dried and irradiated bone becomes brittle. The brittleness of freeze-dried and irradiated bone could be an advantage when impacted as bone morsels [28], but such bone should be mechanically protected if used as a structural graft.

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VIII.

STERILIZATION

The basic aim in sterilizing musculoskeletal tissue is to reduce the probability of nding viable microorganism on the sterilized tissue to one in a million [29]. To achieve this, the bacterial load of tissue must be assessed rst before being sterilized. In addition, the processing of the tissue should be controlled and standardized to keep the bacterial load as small as possible. The effectiveness of the sterilizing method will depend on the initial bacterial load, the sensitivity of the microorganism to the sterilizing agent, and the duration of exposure. It should be emphasized at this point that the use of sterilization in tissue banking does not replace the screening of the donor.

A.

Irradiation

The two principal sources of irradiation are gamma rays from a cobalt 60 source and accelerated electrons generated by an accelerator. Gamma rays have an excellent penetration capacity. In contrast, electrons as charged particles cannot penetrate deeply. The usual and legal dose in most European countries to sterilize the tissue is 25 kGy (1 Gy 100 rad). Although this dose is appropriate for bacteria, it is not effective against HIV [30 32]. The radiosensitivity of hepatitis viruses is also not known, but recent clinical data suggest that hepatitis C contaminated tissues do not transmit the virus after irradiation [16]. Prions are strongly resistant to radiation [33,34]. Mechanically, fresh-frozen irradiated cortical bones have their resistance decreased by about 20% in exion from a dose of 30 kGy and from 60 kGy in compression [35,36]. In contrast, fresh-frozen cancellous bone is not affected by 25 kGy irradiation when tested in compression [37]. Compared to deep-freezing, freeze-drying causes a 20% loss in compression, while adding 25 kGy irradiation causes a further decrease to a nal loss of 42% in compression. Biologically, gamma irradiation of fresh-frozen bone containing bone marrow can generate toxic effects on osteoblasts [22].

B.

Ethylene Oxide

This alkylating gas has long been used but has now been discontinued in most countries because the by-products generated produce an inammatory reaction [38]. Nevertheless, ethylene oxide is able to penetrate cortical bone to sterilize musculoskeletal tissue and as such is still in use in some European countries [39,40].

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IX.

FROM FEMORAL HEAD TO BONE MORSEL

Usually, femoral heads that are allowed to enter the circuit will be cut in two halves. Any cartilage residue is removed as it can inuence the mechanical behavior of the morsels [41]. They are physically and chemically processed and then milled to morsels (Fig. 1). Different models of bone mills vary in the particle sizes they produce [42]. They are packed in plastic vials or envelopes, each containing 15 cc of bone vole (Figs. 2, 3). A whole femoral head will give about 4 units. Depending on the wish of the surgeon, they are either freeze-dried or deepfrozen. Freeze-dried morsels must rst be reconstituted in saline for 10 minutes before being used. Deep-frozen morsels will be thawed before use.

X.

RECORD KEEPING

Records should accurately identify all the information pertaining to the donor and all the steps in tissue processing, if any. Release of the tissue should be documented, including the name of the recipient and date of use. All the data about the donor, the donors family, and the recipients must be treated as condential. Record keeping should also be organized in such a manner that tissue tracking is possible.

Figure 1 Morselization of processed bone originating from a femoral head.

Graft Harvest and Storage

19

Figure 2 Final aspect of a processed and freeze-dried bone morsels packed in a double-wrapped vial. This envelope can be stored at room temperature.

Figure 3 The envelope has been opened in the operating theater. The surgeon will now take from the vial the freeze-dried bone morsels for reconstitution and use.

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XI.

CONCLUSIONS

Tissue banking has many steps, each requiring constant attention, from donor selection to nal delivery to the surgeon. This is not easy and requires dedication to high standards. The nal aim is to provide a safe and appropriate grafting material. The surgeon must assist the tissue bank in either participating at the 6month blood testing in case of femoral heads or verifying the appropriateness of the graft to be implanted.

REFERENCES
1. Blackley HR, Davis A, Hutchinson C, Gross A. Proximal femoral allografts for reconstruction of bone stock in revision arthroplasty of the hip. J Bone Joint Surg 2001; 83A: 346 354. Delloye Ch, Vincent A. The use of massive proximal femoral allografts in hip surgery. In: Older J, ed. Bone Implant Grafting. London: Springer-Verlag, 1992: 117 124. Campbell D, Oakeshott R. HIV infection of human cartilage. J Bone Joint Surg 1996; 78-B: 22 25. Nemzek J, Arnoczky S, Swenson C. Retroviral transmission by the transplantation of connective-tissue allografts. An experimental study. J Bone Joint Surg 1994; 76-A: 1036 1041. Tomford W. Transmission of disease through transplantation of musculoskeletal allografts. J Bone Joint Surg 1995; 77-A: 1742 1754. Simonds R, Holmberg S, Hurwitz R, Coleman TR, Botteneld S, Conley LJ, et al. Transmission of human immunodeciency virus type 1 from a seronegative organ and tissue donor. N Engl J Med 1992; 326: 726 732. Standards for Tissue Banking. McLean, VA: American Association of Tissue Banks, 2001. Common Standards for Musculo-skeletal Tissue Banking. Vienna: European Association of Tissue Banks and European Association of Musculoskeletal Transplantation, 1997. Jensen T. Rhesus immunization after bone allografting. A case report. Acta Orthop Scand 1987; 58: 584. Johnson C, Brown B, Lasky L. Rh immunization caused by osseous allograft. Lancet 1985; 312: 121 122. Friedlaender G, Strong D, Sell K. Studies on the antigenicity of bone. I. Freeze-dried and deep-frozen bone allografts in rabbits. J Bone Joint Surg 1976; 58-A: 854 858. Stevenson S, Horowitz M. The response to bone allografts. J Bone Joint Surg 1992; 74-A: 939 950. Hernigou P, Glorion C, Girard-Pipau F, Deriot H, Goutallier D. Liberation in vitro et ` partir des greffes osseuses. Rev Chir Orthop 1992; 78 in vivo des antibiotiques a (suppl 1): 217.

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Witso E, Loseth K, Bergh K. Adsorption and release of antibiotics from morselized cancellous bone. In vitro studies of 8 antibiotics. Acta Orthop Scand 1990; 70: 298 304. Simonds R. HIV transmission by organ and tissue transplantation. AIDS 1993; 7 (suppl 2): S35 S38. Conrad EU, Gretch DR, Obermeyer KR, Moogk MS, Sayers M, Wilson JJ, et al. Transmission of the hepatitis C virus by tissue transplantation. J Bone Joint Surg 1995; 77-A: 214 224. Horsburgh C, Ou C, Jason J. Duration of human immunodeciency virus infection before detection of antibody. Lancet 1989; 2: 637 640. Busch M, Lee L, Satten G, et al. Time course of detection of viral and serological markers preceding human immunodeciency virus type-1 seroconversion: implications for screening of blood and tissue donors. Transfusion 1995; 3: 91 96. Lelie P, Zaaijer H, Cuypers H. Risk of virus transmission by tissue, blood and plasma products. Transpl Proc 1996; 28: 2939. Allograft-associated bacterial infections. MMWR 2002; 51: 207 210. Thoren K, Aspenberg P, Thorngren KG. Lipid extraction decreases the specic immunologic response to bone allografts in rabbits. Acta Orthop Scand 1993; 64: 44 46. Moreau M.F, Gallois Y, Basle M.F, Chappard D. Gamma irradiation of human bone allografts alters medullary lipids and releases toxic compounds for osteoblast-like cells. Biomaterials 2000; 21: 369 376. Feinstone S, Mihalik K, Kamimura T, Alter H, London W, Purcell R. Inactivation of hepatitis B virus and non-A, non-B hepatitis by chloroform. Infect Immun 1983; 41: 816 821. World Health Organization. Report of a WHO consultation on public health issues related to animal and human spongiform encephalopathies. WHO/CDS/VPH/ 92.104, 1992. Anglen J, Apostoles P, Christensen G, Gainor B, Lane J. Removal of surface bacteria by irrigation. J Orthop Res 1996; 14: 251 254. ` Fages J, Marty A, Delga C, Condoret JS, Combes D, Frayssinet P. Use of supercritical CO2 for bone delipidation. Biomaterials 1994; 15: 650 656. Delloye Ch. Bone banking in orthopaedic surgery. 55-020-E-10, Paris: Editions Scientiques et Medicales Elsevier SAS, 2000. Cornu O, Banse X, Docquier PL, Luyckx S, Delloye Ch. Effect of freeze-drying and gamma irradiation on the mechanical properties of human cancellous bone. J Orthop Res. 2000; 18: 426 431. Darbord JC, Laizier J. A theoretical basis for choosing the dose in radiation sterilization of medical supplies. Int J Pharma 1987; 37: 1 10. Conway B, Tomford W, Mankin HJ, Hirsch MS, Schooley RT. Radiosensitivity of HIV-1. Potential application to sterilization of bone allografts. AIDS 1991; 5: 608 609. Hernigou P, Marce D, Julieron A, Marinello G, Dormont D. Sterilisation osseuse par irradiation et virus VIH. Rev Chir Orthop 1993; 79: 445 451. Fideler B, Vangness T, Moore T, Li Z, Rasheed S. Effects of gamma irradiation on the human immunodeciency virus. A study in frozen human bone-patellar

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Delloye et al. ligament-bone grafts obtained from infected cadavera. J Bone Joint Surg 1994; 76-A: 1032 1035. Forsell J. Irradiation of musculoskeletal tissues. In: Tomford W, ed. Musculoskeletal Tissue Banking. New York: Raven, 1993: 149 180. Dormont D. Creutzfeldt-Jakob disease and transplantation: facts and fables. Transpl Proc 1996; 28: 2931 2933. Loty B, Courpied J, Tomeno B, Postel M, Forest M, Abelanet R. Radiation sterilized bone allografts. Int Orthop 1990; 14: 237 242. Loty B. Allogreffes osseuses: aspects fondamentaux et techniques de conservation en 1992. In: Duparc J, ed. Conferences dEnseignement 1992. Paris: Expansion Scientique Francaise, 1992: 211 237. Anderson M, Keyak J, Skinner H. Compressive mechanical properties of human cancellous bone after gamma irradiation. J Bone Joint Surg 1992; 74A: 747 752. Jackson D, Windler G, Simon T. Intra-articular reaction associated with the use of freeze-dried ethylene oxide-sterilized bone-patellar tendon-bone allografts in the reconstruction of the anterior cruciate ligament. Amer J Sports Med 1990; 18: 1 11. Prolo D, Pedrotti P, White D. Ethylene oxide sterilization of bone dura mater, and fascia lata for human transplantation. Neurosurgery 1980; 6: 529 539. Kearney J. Sterilization of human tissue implants. Tissue Cell Rep 1997; 4: 33 36. Bavadekar A, Cornu O, Godts B, Delloye C, Van Tomme J, Banse X. Stiffness and compactness of morselized grafts during impaction: an in vitro study with human femoral heads. Acta Orthop Scand 2001; 72: 470 476. Brewster N, Gillespie W, Howie C, Madabhushi S, Usmani A, Fairbairn D. Mechanical considerations in impaction bone grafting. J Bone Joint Surg. 1999; 81-B:118 124.

33. 34. 35. 36.

37. 38.

39. 40. 41.

42.

3
The Procurement, Processing, and Preservation of Allograft Bone
Stephan Vehmeijer
Leiden University Medical Centre, Netherlands Bone Bank Foundation Leiden, The Netherlands

Rolf M. Bloem
Reinier de Graaf Hospital, Netherlands Bone Bank Foundation Delft, The Netherlands

I.

INTRODUCTION

During the past decades the use of bone allografts has become widely accepted for the lling of skeletal defects in a variety of surgical procedures. In particular, in the eld of orthopedic surgery the demand for allograft bone has increased rapidly [1 6]. Grafts are primarily used to ll the skeletal defects associated with the loosening of total joint replacements, either as morselized and then impacted or as structural grafts [5,7,8]. The selection of an allograft for these procedures requires an understanding of the procurement, processing, and preserving methods utilized by tissue banks. In addition, the orthopedic surgeon should be aware of the risks associated with the transplantation of allografts, in particular with the preventative measures taken by a tissue bank. This chapter will describe the methods of bone allograft procurement and will provide a brief overview of the different processing and preservation techniques available to tissue banks.

II.

ALLOGRAFT PROCUREMENT

Allografts may be obtained from either living or postmortem donors. Hospitalbased tissue banks mainly retrieve allografts from living donors undergoing
23

24

Vehmeijer and Bloem

primary total hip replacement for osteoarthritis or hemiarthroplasty for hip fractures. Larger (inter-) national operating tissue banks obtain allografts mainly from postmortem donors. Large bone segments can be retrieved from these donors, which can be used for reconstructive surgery in orthopedic oncology or in revision arthroplasty [2,4,9]. Grafts can also be processed into smaller units and applied in spinal fusions or used for the lling of bone defects associated with bone cysts or loosening of total joint replacements [5,7,8,10,11]. Postmortem tissue retrieval may be performed in mortuaries. However, due to the higher incidence of organisms cultured from grafts harvested in mortuaries [12], some tissue banks prefer procurement in an operating theater under aseptic conditions, thus minimizing the initial bacterial load of the grafts.

III.

DISEASE TRANSMISSION

Standards have been developed that require tissue banks to perform thorough screening of donors medical and social history combined with extensive serological and bacterial screening. These have improved the safety of musculoskeletal allografts in recent decades [13]. In adequately screened allografts, the risk of transmitting human immunodeciency virus (HIV) and other viruses has been estimated to be one in 1.6 million [13]. Furthermore, in the past 10 years no new cases of HIV or hepatitis transmission have been reported. The combined standards for musculoskeletal tissue banking of the European Association of Tissue Banks (EATB) and the European Association of Musculoskeletal Transplantation (EAMST) require tissue banks to perform antibody tests for HIV 1/2, hepatitis C, and syphilis, and antigen tests for hepatitis B [14]. A limited number of tissue banks will also perform antigen or even polymerase chain reaction (PCR) tests for HIV and hepatitis C for additional safety. Bacterial infections seem to be more associated with the use of large allografts in major reconstructions after the resection of bone tumors [2,15 18]. The incidence of infections associated with the use of allografts in the impaction technique is low [5,8]. No reports of graft-related infections with this technique were found in the literature. However, a recent report on the death of one patient due to bacterial sepsis after the transplantation of a femoral condyle allograft proves the necessity of vigorous bacterial screening [19]. No microorganisms were cultured from any of the cultures obtained from this patient. One other patient who received grafts from the same donor, however, developed serious infectious complications caused by Clostridium species. It was presumably this anaerobic organism that caused the sepsis in the rst patient. Therefore, to decide whether a graft is adequate for transplantation purposes, it is essential to determine whether and to what degree a procured graft

Bone Allograft Procurement and Processing

25

is contaminated with microorganisms. This is of even more importance if a tissue bank decides to allocate minimally processed grafts for limited indications. This should, however, also be applied to grafts that are processed because some processing methods will only reduce and not eliminate the bacterial load. The combined standards for musculoskeletal tissue banking require that representative samples of each retrieved tissue are cultured if they are to be aseptically processed without terminal sterilization [14]. Obtaining blood cultures is recommended if procurement is performed on a postmortem donor as an additional evaluation on the state of the donor and the eventual interpretation of the culture results of the grafts themselves. The majority of tissue banks perform only tissue cultures, as they consider this a more direct method to determine the bacterial load. Samples from representative areas of the graft are incubated in broth, which is then subcultured. This method is highly sensitive for samples contaminated with microorganisms. It is, however, unlikely that microorganisms present on the allografts surface are evenly distributed. As a consequence, since samples are taken from a limited number of sites on the graft, sampling error is possible. Another method to determine the bacterial load of allografts is the swab culture technique. The entire surface of a graft is swabbed. The swab stick is inoculated onto culture plates, and the swab stick itself is incubated in broth that is then subcultured. This method allows for a semi-quantitative assessment of the bacterial load of a graft. The value of an additional broth culture has, however, been disputed [20,21]. A major disadvantage of the swab culture technique is that only the external surface is sampled. Microorganisms inside the graft, disseminated hematogenously, can remain undetected. To detect these organisms, some tissue banks, such as the Netherlands Bone Bank Foundation, perform postmortem blood cultures. These cultures may facilitate the detection of microorganisms that have spread hematogenously and other organisms, such as anaerobic Clostridium species, which are difcult to detect with either the tissue or the swab culture technique [22].

IV.

PROCESSING METHODS

Bone and soft tissue allografts are often further processed to facilitate their use and to provide additional safety. Allografts are debrided from soft tissue, cut to size, and treated with disinfection or sterilization techniques using various methods. These procedures are mainly aimed at reducing the risk of grafttransmitted diseases, but they should be explicitly considered additional to thorough screening of the donors medical and social history and bacterial and virological screening tests.

26

Vehmeijer and Bloem

The extent to which a graft is processed and preserved is partly dictated by its utilization. For the majority of grafts used in orthopedic procedures, including the impaction technique, however, biomechanical and occasionally biological properties are of lesser importance, and a wide range of disinfection or sterilization and preservation techniques may be employed.

A.

Cleaning and Debridement of Donor Tissue

Processing of bone tissue generally starts with the removal of excessive soft tissue, periosteum, and bone marrow. This alone will reduce the risk of disease transmission, as was demonstrated by Simonds, who described a case of transmission of HIV-1 by transplantation of bone tissues [13]. Three recipients of unprocessed fresh-frozen bone were infected with HIV-1. The recipient, however, of tissue from which the bone marrow had been removed by the transplanting surgeon tested negative for HIV-1 antibody, as did three recipients of lyophilized soft tissue and 25 recipients of ethanol-treated bone. This underlines the necessity for further processing, even if minimally, of donor tissues. After debridement of excessive tissue, grafts may be cut to size and subsequently washed with or soaked in sterile water and detergents, which will further decrease the risk of transmission.

B.

Disinfection and Sterilization

Tissue banks employ different disinfection and sterilization techniques. In these procedures, disinfection should be explicitly distinguished from sterilization. Disinfection is the reduction of the number of viable microorganisms to a level appropriate for safe use on a patient where sterilization of the device is neither necessary nor possible. Disinfection may also be used as a preliminary step to sterilization, if necessary. Sterilization is a validated process used to render a device (or tissue) free from all form of viable microorganisms (ISO 11137, 1995). The methods for disinfection and sterilization of donor tissue are categorized as either aseptic processing or terminal sterilization. In aseptic processing, grafts are procured using aseptic techniques and processed in clean rooms under stringent sterile conditions. Steps to inactivate viruses may be included and stringent bacterial monitoring is performed. Terminal sterilization employs techniques such as irradiation or ethylene oxide to achieve sterility of the tissues as a terminal processing step, while procurement and processing are performed under less stringent conditions. Sterilization is performed with the tissue in its nal packaging.

Bone Allograft Procurement and Processing

27

C.

Chemical Treatment

Different chemical agents are used for disinfection purposes. Alcohols (methanol, ethanol) are used by a majority of tissue banks to remove fat, while antibiotics and a variety of detergents are used to further disinfect the tissue. Some of these methods have been studied extensively and were demonstrated to affect neither the strength of the tissue nor the incorporation of the graft into the host [24,25]. Other agents employed to disinfect the tissue include peracetic acid in combination with ethanol. No thorough studies of the biomechanical and biological effects of this agent on the graft have been described, but the bacterial and viral inactivation capabilities seem favorable [26,27]. D. Irradiation

Sterilization or disinfection of tissue with gamma irradiation is primarily performed using a 60 cobalt source. For aseptic processing purposes, irradiation may be used to reduce the initial bacterial load present on the graft. Based on the procurement culture results, grafts are pretreated with a low dose (10 18 kGy) of gamma irradiation, which will effectively destroy microorganisms present on the external surface of the graft. This method was shown to compromise neither the strength of the graft nor the ability of the graft to effectively incorporate into the host [25]. However, irradiation of large bone allografts, even in low dosages, was associated with a higher rate of fracture when used for the replacement of defects after removal of bone tumors [28]. The use of irradiated grafts for these purposes should therefore be avoided. Irradiation may also be employed to terminally sterilize grafts. Higher doses up to 30 kGy are necessary to eradicate all bacterial microorganisms and viruses, but these doses seriously impair the mechanical properties of various types of grafts [29 31]. In addition, it may negatively affect the osteoinductivity, in particular when grafts are not properly demulsied [32 34]. E. Gas Sterilization

Sterilization with ethylene oxide has had widespread use in tissue banking. Its bactericidal and antiviral effect make it an excellent sterilization method for bone allografts. Two problems exist with the use of ethylene oxide. First, the agent is possibly carcinogenic [35]. Second, acceptable levels of ethylene oxide or its residuals in bone allografts have not been established, and toxic residuals may still be present in the graft after sterilization. This causes an inammatory response in the recipient, which may lead to recovery of the graft [36]. In

28

Vehmeijer and Bloem

addition, bone incorporation was found to be impaired in ethylene oxide treated grafts [37], although controversy exists on this aspect [38]. F. Heat Treatment

Processing devices of femoral heads using moderate heat are now widely in use. Grafts are heated up to 808C, which provides a bactericidal and antiviral effect. It is easy to use and enables hospitals to continue their tissue banking activities while providing additional safety. The method, however, seriously affects osteoinductive capacities of the graft [39]. In addition, the material loses its socalled stickiness, which is essential for the impaction technique [5,8]. G. New Technologies

Several new techniques have been developed that claim to disinfect or sterilize bone allografts without affecting their essential properties. These include treatment of grafts with supercritical CO2 [40,41] and the Biocleansew process. There were no reports of the latter found in the literature. Both methods employ proprietary techniques.

V. A.

PRESERVATION TECHNIQUES Freezing

Freezing to temperatures of 220 to 2808C is thought not to affect the biomechanical properties of bone allografts adversely [42,43]. Furthermore, it is thought to reduce the immunogenicity of the graft [44]. The technique is therefore very appropriate for the preservation of bone and tendon allografts. Despite the advantages of this method of preservation, the high costs associated with the acquisition and maintenance of freezers forced many tissue banks to search for alternatives. B. Freeze-Drying

Freeze-drying has become a popular technique for the preservation of bone tissue allografts. Employing this technique, moisture is eliminated from the tissue under pressure at low temperature. This allows for storage of the grafts at room temperature up to 5 years after packaging. The technique seriously affects the mechanical strength of the material [43,45], which makes it unsuitable for the preservation of large grafts and tendons. It does not, however, impair the osteoinductive capacity of bone tissue [46] and therefore provides an alternative to the preservation of tissues used for the lling of simple bone defects like

Bone Allograft Procurement and Processing

29

cysts [11]. Some surgeons also use freeze-dried allografts for the impaction technique. However, in the centers that rst employed this technique, only frozen cancellous bone chips were used [5,8]. No studies into the mechanical stability of the reconstructions after impaction have been performed that compare freezedried with frozen bone chips. The long-term results of this technique with the use of freeze-dried chips may prove to be different than when frozen chips have been used.

VI.

RECOMMENDATIONS

Orthopedic surgeons should be aware of the potential risks involved with the transplantation of bone tissue. However, the adoption of international standards by tissue banks involving, for example, guidelines for the screening of transmissible diseases, has minimized these risks. In addition to donor screening, processing provides improved safety. Different techniques are used for this purpose. One should bear in mind that these processing techniques seriously affect the mechanical and biological properties of a graft. The extent to which the graft is processed and preserved is therefore partly dictated by its use. For the impaction technique the biological properties, which determine graft incorporation, are more important than the mechanical strength. It is also important that the graft maintains its so-called stickiness. A low dose of gamma irradiation (10 20 kGy) will not affect the biological properties of a graft and seems a suitable method of decontamination [25]. Additional chemical demulsication and decontamination procedures may enhance incorporation and provide additional safety [24,25,33]. Either of these methods or a combination of both will provide an effective and adequate graft. Some tissue banks may provide frozen aseptically processed cancellous bone chips that are cut to shape to the adequate size for the impaction technique. These seem to be the most favorable to use. For the surgeon who does not have a freezer at his disposal, freeze-dried cancellous chips are available. There have been to date no reports, however, that the results of revision arthroplasty in which these grafts were utilized have been comparable to those in which frozen chips were used.

REFERENCES
1. 2. Ghazavi MT, Stockley I, Yee G, et al. Reconstruction of massive bone defects with allograft in revision total knee arthroplasty. J Bone Joint Surg 997; 79-A: 17 25. Mankin HJ, Gebhardt MC, Jennings LC, et al. Long-term results of allograft replacement in the management of bone tumors. Clin Orthop 1996; 324: 86 97.

30 3.

Vehmeijer and Bloem Noyes FR, Barber-Westin SD. Reconstruction of the anterior cruciate ligament with human allograft. Comparison of early and later results. J Bone Joint Surg 1996; 78-A: 524 537. Ortiz-Cruz E, Gebhardt MC, Jennings LC, et al. The results of transplantation of intercalary allografts after resection of tumors. A long-term follow-up study. J Bone Joint Surg 997; 79-A: 97 106. Slooff TJ, Buma P, Schreurs BW, et al. Acetabular and femoral reconstruction with impacted graft and cement. Clin Orthop 1996; 324: 108 115. van Arkel ER, de Boer HH. Human meniscal transplantation. Preliminary results at 2 to 5-year follow-up. J Bone Joint Surg 1995; 77-B: 589595. Garbuz D, Morsi E, Mohamed N, et al. Classication and reconstruction in revision acetabular arthroplasty with bone stock deciency. Clin Orthop 1996; 324: 98 107. Gie GA, Linder L, Ling RSM, et al. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993; 75-B: 14 21. Head WC, Malinin TI. Results of onlay allografts. Clin Orthop 2000; 371: 108 112. Buttermann GR, Glazer PA, Hu SS, et al. Revision of failed lumbar fusions. A comparison of anterior autograft and allograft. Spine 1997; 22: 2748 2755. Spence KF, Jr., Bright RW, Fitzgerald SP, et al. Solitary unicameral bone cyst: treatment with freeze-dried crushed cortical-bone allograft. A review of one hundred and forty-four cases. J Bone Joint Surg 1976; 58-A: 636 641. Bettin D, Harms C, Polster J, et al. High incidence of pathogenic microorganisms in bone allografts explanted in the morgue. Acta Orthop Scand 1998; 69: 311 314. Tomford WW. Transmission of disease through transplantation of musculoskeletal allografts. J Bone Joint Surg 1995; 77-A: 1742 1754. EAMST, EATB. Common Standards for Musculoskeletal Tissue Banking. Vienna: European Association for Musculo Skeletal Transplantation and European Association of Tissue Banks, 1997. Lord CF, Gebhardt MC, Tomford WW, et al. Infection in bone allografts. Incidence, nature, and treatment. J Bone Joint Surg 1988; 70-A: 369 376. Tomford WW, Thongphasuk J, Mankin HJ, et al. Frozen musculoskeletal allografts. A study of the clinical incidence and causes of infection associated with their use. J Bone Joint Surg 1990; 72-A: 1137 1143. Dick HM, Strauch RJ. Infection of massive bone allografts. Clin Orthop 1994; 306: 46 53. Mnaymneh W, Malinin TI, Lackman RD, et al. Massive distal femoral osteoarticular allografts after resection of bone tumors. Clin Orthop 1994; 303: 103 115. Update: allograft-associated bacterial infectionsUnited States 2002. MMWR 2002; 51: 207 210. Silletti RP, Ailey E, Sun S, et al. Microbiologic and clinical value of primary broth cultures of wound specimens collected with swabs. J Clin Microbiol 1997; 35: 2003 2006. Morris AJ, Wilson SJ, Marx CE, et al. Clinical impact of bacteria and fungi recovered only from broth cultures. J Clin Microbiol 1995; 33: 161 165. Vehmeyer SB. Bacterial contamination of bone allografts. Thesis, Leiden University, Leiden, The Netherlands, 2002.

4.

5. 6. 7.

8. 9. 10. 11.

12. 13. 14.

15. 16.

17. 18. 19. 20.

21. 22.

Bone Allograft Procurement and Processing 23.

31

24. 25. 26.

27.

28. 29.

30. 31. 32. 33. 34.

35.

36.

37. 38. 39. 40. 41.

Simonds RJ, Holmberg SD, Hurwitz RL, et al. Transmission of human immunodeciency virus type 1 from a seronegative organ and tissue donor [see comments]. N Engl J Med 1992; 326: 726 732. Boyce T, Edwards J, Scarborough N. Allograft bone. The inuence of processing on safety and performance. Orthop Clin North Am 1999; 30: 571 581. Jinno T, Miric A, Feighan J, et al. The effects of processing and low dose irradiation on cortical bone grafts. Clin Orthop 2000; 375: 275 285. Pruss A, Kao M, Kiesewetter H, et al. Virus safety of avital bone tissue transplants: evaluation of sterilization steps of spongiosa cuboids using a peracetic acid-methanol mixture. Biologicals 1999; 27: 195 201. Wutzler P, Sauerbrei A. Virucidal efcacy of a combination of 0.2% peracetic acid and 80% ethanol (PAA-ethanol) as a potential hand disinfectant. J Hosp Infect 2000; 46: 304 308. Lietman SA, Tomford WW, Gebhardt MC, et al. Complications of irradiated allografts in orthopaedic tumor surgery. Clin Orthop 2000; 375: 214 217. Fideler BM, Vangsness CT, Jr., Lu B, et al. Gamma irradiation: effects on biomechanical properties of human bone-patellar tendon-bone allografts. Am J Sports Med 1995; 23: 643 646. Hamer AJ, Suvarna SK, Stockley I. Histologic evidence of cortical allograft bone incorporation in revision hip surgery. J Arthroplasty 1997; 12: 785 789. Pelker RR, Friedlaender GE. Biomechanical aspects of bone autografts and allografts. Orthop Clin North Am 1987; 18: 235 239. Ijiri S, Yamamuro T, Nakamura T, et al. Effect of sterilization on bone morphogenetic protein. J Orthop Res 1994; 12: 628 636. Thoren K, Aspenberg P, Thorngren KG. Lipid extracted bank bone. Bone conductive and mechanical properties. Clin Orthop 1995; 311: 232 246. Moreau MF, Gallois Y, Basle MF, et al. Gamma irradiation of human bone allografts alters medullary lipids and releases toxic compounds for osteoblast-like cells. Biomaterials 2000; 21: 369 376. Stayner L, Steenland K, Greife A, et al. Exposure-response analysis of cancer mortality in a cohort of workers exposed to ethylene oxide. Am J Epidemiol 1993; 138: 787 798. Jackson DW, Windler GE, Simon TM. Intraarticular reaction associated with the use of freeze-dried, ethylene oxide-sterilized bone-patella tendon-bone allografts in the reconstruction of the anterior cruciate ligament. Am J Sports Med 1990; 18: 1 10. Thoren K, Aspenberg P. Ethylene oxide sterilization impairs allograft incorporation in a conduction chamber. Clin Orthop 1995; 318: 259 264. Aspenberg P, Lindqvist SB. Ethene oxide and bone induction. Controversy remains. Acta Orthop Scand 1998; 69: 173 176. Urist MR, Silverman BF, Buring K, et al. The bone induction principle. Clin Orthop 1967; 53: 243 283. Fages J, Poirier B, Barbier Y, et al. Viral inactivation of human bone tissue using supercritical uid extraction. Asaio J 1998; 44: 289 293. Frayssinet P, Rouquet N, Mathon D, et al. Histological integration of allogeneic cancellous bone tissue treated by supercritical CO2 implanted in sheep bones. Biomaterials 1998; 19: 2247 2253.

32 42.

Vehmeijer and Bloem Hamer AJ, Strachan JR, Black MM, et al. Biochemical properties of cortical allograft bone using a new method of bone strength measurement. A comparison of fresh, fresh-frozen and irradiated bone. J Bone Joint Surg 1996; 78-B: 363368. Pelker RR, Friedlaender GE, Markham TC, et al. Effects of freezing and freezedrying on the biomechanical properties of rat bone. J Orthop Res 1984; 1: 405 411. Stevenson S, Li XQ, Davy DT, et al. Critical biological determinants of incorporation of non-vascularized cortical bone grafts. Quantication of a complex process and structure. J Bone Joint Surg [Am] 1997; 79-A: 1 16. Simonian PT, Conrad EU, Chapman JR, et al. Effect of sterilization and storage treatments on screw pullout strength in human allograft bone. Clin Orthop 1994; 302: 290 296. Hosny M, Arcidi C, Sharawy M. Effects of preservation on the osteoinductive capacity of demineralized bone powder allografts. J Oral Maxillofac Surg 1987; 45: 1051 1054.

43. 44.

45.

46.

4
Conserving Stocks in the Bone Bank
David Finlayson
Raigmore Hospital Inverness, Scotland

Philip Henman
Freeman Hospital Newcastle upon Tyne, England

I.

INTRODUCTION

Impaction grafting is using increasing quantities of bone allograft. Not only are the numbers of procedures increasing, but this technique is a new use for allograft and, therefore, impinges on the existing supply of banked bone. Greenwald et al. [1] have estimated that more than 500,000 bone graft procedures are done annually in the United States. They suggest that double that number are now being done worldwide. While at least some of these procedures are in spinal surgery, the remainder include a variety of indications where there is loss of bone stock. These include the increasing indication of impaction grafting for the reconstruction of defects in revision hip surgery, rst described by Schreurs et al. for the acetabulum in 1984 [2] and later extended to the femur by Gie et al. [3]. In a more recent report [4] acetabular reconstruction was described as requiring between one and three femoral heads, but no further guidelines are available to accurately describe the amount of bone that might be used for these extensive reconstructions. In addition to the successful use of the technique in the hip, some surgeons are now extending this to revision of the failed knee replacement with bone loss. The consequence of this increased activity and demand for allograft is an existing shortfall in the supply of banked bone, and this is predicted to increase [5]. Orthopedic surgeons are thus in competition among themselves to secure supplies of scarce and expensive resource.
33

34 Table 1 Prices for Bone Allograft in Scotland 320 ($512) 250 ($400) 356 ($569.60) 155 ($248)

Finlayson and Henman

Femoral heads (fresh frozen) Tibial plateau (fresh frozen) Freeze-dried ground bone (35 cc) Freeze-dried ground bone (15 cc)

Exchange rate as of Sep. 16, 2003.

Table 1 shows the current costs of allograft materials supplied by the tissue division of the Scottish National Blood Transfusion Service. Although no charge for these materials is made to Scottish Health Service Hospitals because of the funding arrangements, this charge is levied for any bone supplied outside of Scotland or indeed to the Scottish private sector. If the recommendations of Schreurs et al. [4] are followed and three femoral heads are used for one acetabular reconstruction, the problem of supply is easy to comprehend. This chapter will present the reasons for and implications of the supply problems in allograft bone and then consider the mechanisms that might be put in place to increase the amount of bone available. More importantly, the principle of issuing allograft bone by weight rather than number of pieces of bone will be discussed as a means to enable self-sufciency in this commodity.

II.

AVAILABILITY OF BONE

The availability of bone is limited by a number of factors, not least of which is the organization of the bone bank. British hospital bone banks have traditionally been run on an ad hoc basis, usually without signicant funding and often with inadequate facilities to verify the safety of the bone or integrity of the preservation process. In Scotland, however, the national blood transfusion service has taken over by setting up tissue banks in ve regional blood transfusion centers. This has ensured strict selection criteria for both live donors and cadaver harvesting. It has also enabled consistent postharvest surveillance for transmissible infection and careful monitoring of bacterial contamination of grafts at harvest and also at the point of use. This has allowed close monitoring of the potential donors who are rejected at initial screening or postharvest testing. Galea et al. [5] estimated that 48% of potential donors in Scotland are rejected after medical screening. The principal reasons for such rejection in live donors at primary arthroplasty in the north of Scotland include rheumatoid arthritis accounting for 22 30% of deferrals each year, and malignancy, accounting for 10 21% [6]. While the precise reasons for

Conserving Stocks in the Bone Bank

35

such rejection may be subject to considerable geographical variation dependent on the disease characteristics of the donor population, this pattern seems to be similar to that elsewhere in the United Kingdom. Jones et al. [7] reported a similar 48% rejection rate from live donors at primary arthroplasty in Wales. Of the patients accepted as suitable for bone donation, however, only 78% yielded an allograft; among the reasons for this were included 6% of donations that subsequently had positive microbiological specimens at harvest and some bone that was accidentally dropped at the time of primary harvesting. Such problems are likely to occur with all forms of bone harvest, and Deijkers et al. [8] showed that 50% of cadaver grafts were contaminated by skin commensal organisms at the time of harvest. Only 3% of their grafts, however, were contaminated by organisms of high pathogenicity. More importantly, they pointed out that for each staff member added to the procurement team, the risk of contamination with organisms of low pathogenicity increased by a factor of 1.6, showing that the so-called skin commensals are more likely to arise from the procurement team than any other source. While microbiological testing can be satisfactorily carried out with verication of graft sterility at the time of harvest and at the time of use, verication of freedom from transmissible viral infection is more difcult. With live donors, samples must be taken at the time of graft harvest and repeat serological testing done at 6 months after harvest to guarantee identication of any patients who may have seroconverted after the time of graft harvest but who may have been infected at that stage. This policy is clearly not practicable with cadaver donors, for whom the accuracy of a postmortem history taken from family members may not be fully accurate. Identication of viral pathogen using the polymerase chain reaction on such samples as is done for blood transfusion donations is the only practicable means of ensuring the safety of such cadaveric grafts. Even with such precautions, there may still be some concerns about microbiological contamination of grafts leading some bone banks to use radiation for sterilization, but this may have adverse effects on both the mechanical properties and the potential for osteoinduction [8]. The nal concern with allograft bone is the possibility of occult pathology, such as tumors, which has not been identied through careful history taking or the available tests. Palmer et al. [10] analyzed 1146 osteoarthritic femoral heads which were otherwise suitable for harvesting, and they found occult disease in 8%. This led them to recommend that since occult pathological conditions were common, that histological examination should be part of the screening protocol before storage of allograft in the bone bank. Their specimens, however, were all sliced, with examination of only a single central slice being done. What is not mentioned is the amount of bone that would be lost by such examination on a routine basis. The recommendation has not yet become part of standard practice within U.K. tissue banks.

36

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All of the above concerns regarding allograft bone have been addressed in a more rigorous fashion within the United Kingdom since April 2003. National Health Service hospitals now must purchase allograft bone from tissue banks accredited by the U.K. Medicines Control Agency. Since this will involve closure of the informal tissue banks in English hospitals, there may be further shortfall of bone.

III.

IDENTIFICATION OF POTENTIAL DONORS

At present, the majority of allograft harvested by U.K. tissue banks comes from live donors with osteoarthritis undergoing primary total hip replacement. It is likely that this will remain the preferred route for bone harvesting for the following reasons: 1. 2. 3. A full clinical history from the donor is available. Bone harvest is an integral part of a surgical procedure with no additional procedures required. Harvesting is done under the best possible aseptic conditions.

In contrast, cadaver donation, while yielding bulk allografts that cannot be obtained from live donors, has a number of problems, which have made it less attractive within the U.K. setting as follows: 1. 2. 3. Difculty with history taking and possible inaccuracies Requirement for a separate tissue procurement team, increasing the cost of harvest Poor infection control

It is, therefore, clear that the most important means to improve the supply of allograft bone for patients undergoing primary arthroplasty is to ensure identication of potential donors at an early stage before surgery. The amount of bone harvested from osteoarthritic patients can be increased if the cancellous bone that is ordinarily removed from the femoral canal is also harvested. This bone, however, may be difcult to quantify for the purposes of releasing bone from the bank at the time of use, and the solution to this problem is discussed below.

IV.

ALTERNATIVE DONATION SITES

A further source of supply not regularly used is the elderly patient with a subcapital fracture of the hip, being treated by hemiarthroplasty. This bone is assumed to be osteoporotic and hence of poor quality for the purposes of grafting,

Conserving Stocks in the Bone Bank

37

but once compacted there is in theory little difference between this bone and compacted bone from the osteoarthritic patient. The problems of harvesting from the elderly patient relate more to the difculty of taking an accurate history from a group of patients who are often losing their mental faculties and the possibility that the patient may not survive long enough for postharvesting serological testing rather than any specic concerns about the amount of quality of bone that has been harvested. Nonetheless, these patients may remain a valuable source of bone if the concerns regarding history taking and serological testing can be addressed. A nal source of supply that has been little utilized to date is the knee at primary arthroplasty for osteoarthritis. The off cuts from the usual resurfacing knee prostheses may yield valuable cancellous bone, but there would seem to be three objections to its regular use: 1. There may be thick articular cartilage still present on one or other side of the knee with signicant varus or valgus deformity, and it is difcult to remove this once the bone is presented for use. 2. There is often signicant soft tissue left attached to the off cuts with present knee prostheses. 3. It is difcult to equate one set of knee off cuts with femoral heads, which are the traditional measure of available banked bone. It will be seen from the above that while the traditional method of issuing bone via femoral heads allows an apparently easy means of identifying both how much bone is in the bone bank and how much has been ordered for use, there are a number of aws with this system. First, if the surgeon only orders bone bank by the femoral head, then only femoral heads can be used, thus restricting the possibility of using bone from other sources such as bone harvested from the medullary canal or bone taken at primary knee replacement. Second, it makes the assumption that all femoral heads are the same. There is, therefore, no allowance made for the differing density of bone between individual donors. Not all osteoarthritic femoral heads will have the same density, and thus when compacted, the volume of bone will vary from specimen to specimen. This area was investigated in a study at Raigmore Hospital [9] which has issued bone by weight since 1994, approximately 2 years after bone started to be used for this procedure in this hospital. A review of the mass of bone used for impaction grafting procedure between 1994 and 1996 showed that most impaction grafting procedures required approximately 200 g of bone. Studying individual cases further suggested the following recommendations. If only one component is loose without endosteal osteolysis greater than 2 cm in diameter on one radiological view, 150 g of bone will be sufcient. In the presence of loosening of both components with minor endosteal osteolysis or one loose

38 Table 2 Order Schedule for Allograft Bone Extent of lysis None .2 cm None .2 cm

Finlayson and Henman

Number of loose components 1Acetabulum 1Acetabulum 2Acetabulum 2Acetabulum or femur or femur and femur and femur

Order Schedule 150 g 200 250 g 200 250 g .280 g

component with major endosteal osteolysis, 200 250 g will be necessary. When both components are loose and have evident endosteal osteolysis, at least 280 g will be required. This series related, however, to the rst 50 cases, and with experience and care to ensure containment of the graft, it is possible to be more economical than this. Nonetheless, these gures do provide a useful guideline (Table 2). This study was extended by taking some of the femoral heads that had been harvested but subsequently discarded because of bacteriological contamination. This showed, as would be expected, that femoral heads of the same diameter could have great differences in mass. In consequence, when femoral heads of different mass are morselized, differing volumes will be obtained. Since morselization and impaction/compaction completely changed the gross bony architecture of the allograft bone fragment, the precise source of the bone used is irrelevant. It is, therefore, completely illogical to order bone by asking for femoral heads and more logical to ask for bone by weight. This not only ensures that adequate osteoarthritic bone will be provided, but allows bone to be used from a number of different sources. If harvested bone is weighed, it is a simple matter for the surgeon to order the amount of usable graft he or she expects. As supplies of fresh frozen allograft bone become inadequate to meet the demand for impaction grafting procedures, all possible means must be taken to ensure that supply is increased and usage is as efcient and effective as possible. The measures suggested above and summarized below have been found to be effective in one orthopedic unit with its own tissue bank. This has allowed not only self-sufciency in allograft bone since 1992, but also the ability to export bone excess to requirements to neighboring hospitals. The practice of weighing bone is clearly the most effective way to avoid overordering and wastage of bone, which cannot be refrozen once issued. In addition, with the increased regulatory stringency on U.K. tissue banks, bone will increasingly have to be ordered from a tissue bank at a site remote from the user hospital, which makes it all the more important for the surgeon to ensure that the correct amount of bone is ordered and available. The weighing of all

Conserving Stocks in the Bone Bank

39

allograft bone prior to storage and issuing it only by weight must, therefore, be strongly recommended as one of the most effective means of ensuring its proper use.

V. A.

SUMMARY OF RECOMMENDATIONS Increasing Supply 1. Early identication of potential donors 2. Increased pool of potential donors by considering patients having knee arthroplasty and hip fractures 3. Increased harvest from present donors by utilizing femoral canal cancellous bone, which is normally discarded

B.

Avoiding Wastage 1. Bone discarded as unsuitable for freezing because of microbiological contamination should be sent for processing by freeze-drying and sterilization. 2. Issue bone by weight only. 3. Use pieces of bone from varying sites.

REFERENCES
1. Greenwald AF, Boden SD, Goldberg VM, Khan Y, Laurencin CT, Rosier RN. Bone graft substitutes: facts, ctions and applications. J Bone Joint Surg 2001; 83A (suppl 2): 98 103. Slooff TJJH, Huiskes R, Van Horn J, Lemmens AJ. Bone grafting in total hip replacement for acetabular protrusion. Acta Orthop Scand 1984; 55: 593 596. Gie GA, Linder L, Ling RSM, Simon J-P, Slooff TJJH, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993; 73-B: 14 21. Schreurs BW, Slooff TJJH, Buma P, Gardeniers JWM, Huiskes R. Acetabular reconstruction with impacted morsellised cancellous bone graft and cement. A 10 15 year follow up of 60 revision arthroplasties. J Bone Joint Surg 1998; 80-B: 391 395. Galea G, Kopman D, Graham BJM. Supply and demand of bone allograft for revision hip surgery in Scotland. J Bone Joint Surg 1998; 80-B: 595 599.

2. 3.

4.

5.

40 6.

Finlayson and Henman Kropp LC. Seventy-eight percent increase in bone donor referral for malignancy 1998 2000should Highlanders be worried? British Association for Tissue Banking annual meeting, London, April 8 9, 2002. Jones SA, Jones DA, Stephens M, Roberts P. Bone bankingwhat can you expect? British Association for Tissue Banking annual meeting, London, April 8 9, 2002. Deijkers RLM, Bloem RM, Petit PLC, Brand R, Vehmeyer SBW, Veen MR. Contamination of bone allografts analysis of incidence and pre-disposing factors. J Bone Joint Surg 1997; 79-B: 161 166. Norman-Taylor SH, Villar RN. Bone allograft: a cause for concern? J Bone Joint Surg 1997; 79-B: 178 180. Palmer SH, Gibbons CLMH, Athanasou NA. The pathology of bone allograft. J Bone Joint Surg 1999; 81-B: 33 35. Henman P, Finlayson D. Ordering allograft by weight. J Arthroplasty 2000; 15: 368 371.

7.

8.

9. 10. 11.

5
Mechanical Considerations in Impaction Bone Grafting
The Nijmegen Experience
N. Verdonschot, S. B. Bolder, Pieter Buma, and B. Willem Schreurs
University Medical Center Nijmegen Nijmegen, The Netherlands

I.

INTRODUCTION

Initial mechanical stability is a prerequisite for long-term survival of cemented components. This has been elegantly shown by Karrholm et al., who found that in both revisions and primary cemented hips, those with a higher migration rate failed signicantly earlier than more stable reconstructions [1]. In primary total hip replacement (THR), initial stability is usually no problem as the cement secures the component rmly to the surrounding bone, but in cemented revisions it is more difcult to achieve stable cup xation. Initial stability is an equally important issue when impaction bone grafting is used. However, when using this technique it becomes less obvious how stable a reconstruction should be, as a relatively soft layer of impacted morselized graft is situated between the cement and the bone. In more extensive loss of bone stock, segmental bone defects need to be reinforced with metal mesh. Obviously these are not optimal conditions for stable reconstruction. This makes the clinical success of impaction bone grafting highly dependent on the surgical technique used. There are many choices that the surgeon has to make, and surgeons make choices with the best of their ability but sometimes fail to achieve a satisfactory result. This is illustrated by a number of reports in the literature of considerable initial migration of prosthetic components implanted with the impaction bone grafting technique. Eldridge et al. reported massive subsidence of the femoral
41

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Verdonschot et al.

stem after using the impaction bone grafting [2], and Pekkarinen et al. noted a high number of complications in their patients [3]. Masterson et al. observed a considerable number of incomplete femoral cement mantles within the impacted graft layer, resulting in signicant migration in some patients [4]. The purpose of this chapter is to clarify some issues that inuence the initial stability of bone reconstruction with impaction grafting. This should be of use to orthopedic surgeons who wish to optimize their technique and base their decisions on scientic data. First the inherent mechanical characteristics of morselized bone grafts will be described, after which some factors in acetabular and femoral reconstruction are discussed. II. INHERENT MECHANICAL CHARACTERISTICS OF MORSELIZED PARTICLES

From a mechanical perspective, a volume of a morselized bone particle has complex mechanical properties [5 7]. Its stiffness is variable over protracted loading. It gradually deforms over time when loaded for a long period of time (creep) and demonstrates viscoelastic behavior. This means that the deformation is not instantaneous after load application, but is delayed. This is caused primarily by the uid in the graft volume, which needs time to escape from the impacted bone when it is compressed. These mechanical characteristics of a volume of bone graft material can easily be demonstrated by conned compression tests, which we have previously reported [7] (Fig. 1). The morselized grafts were manually impacted in an impermeable, cylindrical test chamber with a diameter of 20 mm. A rigid, porous lter was placed on top of the impacted material, allowing free uid exudation during loading. On top of the lter, a load spreader

Figure 1

Schematic representation of a conned compression test.

Impaction Bone Grafting: Nijmegen Experience

43

ensured that the applied load was equally distributed over the whole surface of the specimen. Using a servo-hydraulic MTS testing machine, a dynamic force ranging from 10 N (minimum force) to 840 N (2.68 MPa, maximum force) was applied with a frequency of 1 Hz for a period of 900 seconds (loading phase). This load level was chosen because it resembles the force expected around cemented cups [8] and femoral implants [9]. After this loading period, the specimens remained unloaded for another 900 seconds, allowing the exudated uid to be sucked back into the specimen. The deformation of the impacted material was measured by an extensometer. The stiffness changed from 85 MPa at the beginning of the test to 135 MPa at the end of the loading period. Hence, the material underwent further impaction by the dynamically applied load, which rendered the material stiffer. Obviously, the values mentioned depend heavily on the initial impaction of the volume in the test chamber. The more impaction applied at that time, the higher the initial stiffness and the smaller the increase during the loading period. The graft volume underwent signicant creep deformation. At the end of the loading phase the deformation was almost 50%. After removal of the load, the morselized grafts recoiled until a total deformation of about 35% was maintained (Fig. 2). Hence, if one starts with a 10 mm high impacted graft layer and loads it dynamically, it may be compressed to a height of 5 mm. If the load is removed, a layer of 6.5 mm is maintained. Again, these values depend on the quality of initial

Figure 2 Deformation of impacted bone grafts as a function of time. The rst 900 seconds a dynamic load was applied; the last 900 seconds was an unloaded period.

44

Verdonschot et al.

Figure 3 The stressstrain relation of impacted bone grafts in a conned compression test measured during one loading cycle. The graph shows that the impacted material is viscoelastic. As an example, a curve of a linear elastic material is also shown.

impaction. It is probably undesirable to have a layer that deforms so much, which emphasizes the point that rm impaction in clinical cases is mandatory. The viscoelastic behavior can be illustrated best by considering one loading cycle (Fig. 3). A material without any viscoelastic properties would deform immediately in response to the load. However, the uid in the graft material is not compressible, which means that the material can only deform if the uid is displaced out of the volume. Obviously there is some resistance to uid transport (depending on the permeability), resulting in a delay of the deformation of the graft material relative to the applied force. Displacing the uid costs energy and the amount of energy lost is represented by the surface contour of the loading and unloading phase on the stressstrain diagram. This kind of curve is called an hysteresis loop (Fig. 3). The more the hysteresis, the higher the viscoelastiticity of the material.

III.

APPLICATION TO THE ACETABULAR SIDE

Relatively little work has been devoted to the analysis of prosthetic stability using the impaction bone grafting technique on the acetabular side. However, it is obvious that the surgical technique and decisions made by the surgeon will affect

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the stability of the reconstruction. Variables that inuence the initial stability are the type of bone graft used, the size of the particles, and the method of impaction applied. The Nijmegen group has always used relatively large particles (8 10 mm in diameter). Initially the morselized chips were impacted by hammering on trial cups; later special acetabular impactors were designed. The larger particles are created with a rongeur by hand and consist of pure cancellous bone. However, this is a time-consuming and tedious part of the procedure. Therefore, surgeons opt to use bone mills for producing these bone chips. After removal of the cartilage the heads are milled, so in contrast to manually produced bone chips from the femoral heads, these chips produced by mills also contain fragments of cortical bone. There is also a considerable risk that cartilage particles are included if the cartilage layer is not removed completely. The other concern about using bone mills is that most available and used bone mills produce relatively small particles (2 3 mm diameter). To assess the effects of particle size on the stability of the acetabular reconstructions, we performed two in vitro experiments. In both experiments we found that smaller bone graft particles lead to a reduced acetabular stability. In an in vitro study with human cadaveric pelvic bones, contained defects were created and subsequently resconstructed with either small or large bone graft particles [10]. The fresh-frozen pelvic bones were mounted on an MTS testing machine, and the cups were dynamically loaded (Fig. 4). Migration (3 rotations and 3 translations) was measured using roentgen stereogrammetric analysis (RSA). Cemented cups were more stable with the larger chips. Migration decreased by 35% if large bone chips were used instead of the smaller ones (Fig. 5). In addition to these cadaveric experiments, we developed a synthetic acetabular model as a practical means of examining more variables (Fig. 6) [11]. This model overcame the limited availability of human cadaveric material, and testing became more reproducible. The synthetic acetabula consisted of an epoxy cylindrical cortex with a wall thickness of 3 mm and an inner porous part 68 mm in diameter made of polyurethane foam. In this model we created a simple cavitary defect, with diameters similar to the previously described cadaveric experiments. The cups were dynamically loaded again, and the migration relative to the synthetic bone was recorded using RSA. Migration of the cemented cup decreased by 25% if the bone defect was reconstructed with large bone chips. Hence, this model showed a similar percentage as found in the cadaveric experiments (Fig. 5). We considered this a validation of our synthetic model and a strong indication that with a similar surgical technique one would obtain inferior stability with small morselized particles. The latter conclusion is supported by other publications [13 17]. From the beginning we clinically used acetabular impactors and a hammer to reconstruct acetabular bone defects with morselized grafts. However, rm

46

Verdonschot et al.

Figure 4 Experimental set-up of the in vitro test to assess the stability of acetabular cups after impaction grafting in cadaver pelvic bones.

impaction does cost precious operating time, and of course these instruments must be available. Some surgeons use a quicker means to impact morselized bone grafts with instruments available in every orthopedic theater; one example is the reversed

Impaction Bone Grafting: Nijmegen Experience

47

Figure 5 Migration values of the cup relative to the bone in the cadaver pelvis and the synthetic model at the beginning and end of the 1500 N loading period and at the beginning and end of the 3000 N loading period. In these two models the chip size was varied. More migration was found with the smaller grafts in both models.

reaming technique (Fig. 7). Hereby, the acetabular reamer is used in reverse in combination with manual compression on the reamer [12]. To assess whether this technique provides adequate reconstructive stability, we simulated this technique in our in vitro models and tested the obtained stability. Another variable we tested in this model was the use of so-called slurry bone grafts. Some surgeons have suggested the use of slurry grafts for bone impaction grafting on the acetabular side. These slurry grafts can be obtained from the acetabulum reamers after the reaming process. These slurry grafts can also be produced from femoral head allografts with reamers. We assessed the reversed reaming and slurry graft techniques by the same in vitro experiment with synthetic models and compared the total migration with larger impacted morselized grafts (Fig. 8). Reversed reaming with small particles increased migration by about 60% and with slurry grafts by about 120%. Hence, slurry grafts and the reversed reaming method should not be used in clinical practice, as it does not lead to a stable reconstruction. Another variable of current interest is washing the morselized grafts prior to application and the inuence of this on the mechanical stability of the reconstruction [18]. Recently we tested this variable on small and large grafts in our synthetic in vitro test and found that washing did indeed improve the stability of the reconstruction [19]. The best stability was obtained with large washed

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Figure 6

The synthetic model used to mimic the acetabulum.

Figure 7 The standard impaction (left) and the so-called reversed reaming method (right).

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Figure 8 Migration values of the cup relative to the synthetic bone. Variables were large bone chips with standard impaction (large imp), small bone chips with standard impaction (small imp), small bone chips with reversed reaming impaction (small rr), and slurry grafts impacted with the reversed reaming method (slurry rr).

particles and the worst with small unwashed morselized grafts. Other authors have suggested that there is an optimal distribution of particle size that would improve the stability further. This is called grading of particle sizes [20]. Cartilage remnants are often included when the femoral head is milled but the cartilage has not been removed completely. Cartilage adversely affects cup stability [21]. The above-mentioned in vitro experiments used a loading conguration that forced cups in a medio-superior direction, thereby simulating instability of the cup and protrusio acetabuli under mainly compressive loads. However, clinically, cups sometimes loosen due to impingement of the femoral neck on the acetabular rim. This results in failure by shear. Compressive failure may not equate to shearing. For this reason we developed an additional test in which the reconstructed cup was rotated in the frontal plane. This test is referred to as the lever-out test (Fig. 9). By recording the moment required for this rotation, the xation strength against shear is recorded. Again, the synthetic acetabulum models were used, and we compared the large versus small grafts and the effect of washing of the grafts prior to impaction. The larger washed grafts produced a signicantly higher degree of shear resistance than the other types of impaction (Fig. 10). Washing smaller grafts made little difference in our model. Ullmark [18] also reported that defatting, which is a process similar to washing, produced a higher shear resistance.

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Figure 9

Schematic representation of the lever-out test.

Based on these mechanical tests, we strongly recommend large bone chips on the acetabular side. Several experiments prove that these chips provide the best cup stability after bone impaction grafting, and all our long-term clinical data on acetabular bone impaction are based on the use of large trabecular bone chips.

IV.

APPLICATION TO THE FEMORAL SIDE

A number of studies have examined variables associated with impaction bone grafting on the femoral side [13,14,22 25].

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Figure 10 Lever-out forces recorded in the lever-out test. Highest forces were found for the large, washed bone grafts.

In 1988 we developed a special set of instruments to perform a reproducible impaction bone grafting on the femoral side in a goat model. Using this instrumented bone graft impaction technique, we assessed the stability of femoral stems with an in vitro RSA experiment. The stems were implanted in goat femora with a circumferential layer of bone grafts. Both cementless as well as cemented stems were used [23 25]. The cemented stems produced a considerably smaller subsidence than the cementless components (subsidence values 0.5 mm vs. 2.9 mm for the cemented and cementless components, respectively). It was concluded that the stability of the cemented stems was adequate, but that additional means of enhancing the stability of cementless components were required. The quality of xation of cemented revision components has been conrmed by Malkani et al. [14], who compared the stability of primary cemented stems and those reconstructed with impaction grafting and found little difference between them. In addition to an enlarged diameter of the femoral cavity, the surgeon is often confronted with segmental bone defect. This is frequently seen in the calcar area. It is mandatory to reconstruct these defects, otherwise the stems will be rotationally unstable. This defect is most frequently reconstructed with metal mesh in combination with cerclage wires but can also be repaired with a cortical strut graft with cerclage wires. The question we were interested in was which of the two techniques would provide the best initial stability. For this purpose we performed an in vitro study on paired goat femurs [26]. A segmental defect was created on the proximo-medial side (calcar region) and reconstructed with one of the two techniques (Fig. 11). The femoral shaft was reconstructed with small morselized bone grafts, after which the prosthesis was cemented in place. The reconstructions were mounted on a MTS testing machine and dynamically loaded such that the prosthesis was forced to rotate into varus, thereby loading the defect

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Figure 11 Schematic representation of a femur with a segmental defect in the calcar region (left), which is reconstruction either by a mesh or a strut graft.

maximally. The migration of the femoral components was measured using RSA (Fig. 12). The stability of the two techniques was similar. Although the strut graft group migrated a little further, the difference was not statistically signicant. Interestingly, the strut graft group migration was very variable with high standard

Figure 12 Varus-rotation values of the prosthesis relative to the bone showing that, on average, the strut graft method and the mesh reconstruction lead to similar prosthetic stability, but that the strut graft procedure leads to a higher variation in prosthetic stability.

Impaction Bone Grafting: Nijmegen Experience

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deviations, whereas the metal mesh group produced highly reproducible results. We explained this phenomenon by the t of the strut graft to the host bone. Very good stability can be achieved if the t is good, but if the t is poor the stability may be inferior. With the metal mesh the t is less critical and results more reproducible. Firm impaction is important on the femoral side. This is demonstrated by several researchers who found that subsidence was greater with poorer impaction. Firm impaction is also important for the survival of the cement mantle. If a cement mantle is surrounded by a soft impacted graft layer, the stresses in the cement mantle will be relatively higher than to a rmly impacted graft layer. This can be nicely demonstrated in nite element computer simulations [27]. Higher stresses lead to earlier failure of the cement mantle, migration of the implant, and failure of the reconstruction. On the femoral side the size of the chips used is limited by the dimensions of the femoral canal. Bone chips that can be used in the distal femur should be no larger than 3 5 mm. Larger chips can only be used more proximally. Hence, the debate on the size of chips to be used is less controversial than on the acetabular side. However, on the femoral side as well, the largest possible chips produce the best stem stability. V. CONCLUSIONS

Morselized bone graft is a viscoelastic material, the mechanical properties of which depend on the quality of impaction. On the acetabular side, large particles produce better stability than smaller ones. Washing improves the stability further. Reversed reaming does not produce adequate stability. Impaction should be done by using a hammer and a special set of instruments. Slurry grafts should not be used as they do not provide a solid basis, but act more like quicksand. Firm impaction is a prerequisite for clinical success on both the acetabular and femoral sides. Smaller grafts may be used on the femoral side because of constraints of size. Segmental defects on the femoral side can be reconstructed equally successfully with either strut grafts or mesh. However, the t between the graft and the host bone is critical when using strut grafts. Firm impaction not only improves the direct stability of the stem, but also protects the cement mantle against high stresses and early failure. REFERENCES
1. Karrholm J, Borssen B, Lowenhielm G, Snorrason F. Does early micromotion of femoral stem prostheses matter? 4 7 year stereoradiographic follow-up of 84 cemented prostheses. J Bone Joint Surg 1994; 76-B: 912 917.

54 2. 3.

Verdonschot et al. Eldridge JDJ, Smith EJ, Hubble MJW, Whitehouse SL, Learmonth ID. Massive subsidence following femoral impaction grafting. J Arthroplasty 1997; 12: 535 540. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavolainen T. Impaction bone grafting in revision hip surgery. A high incidence of complications. J Bone Joint Surg 2000; 82-B: 103 107. Masterson EL, Masri BA, Duncan CP. The cement mantle in the Exeter impaction allografting technique. A cause for concern. J Arthroplasty 1997; 12: 759 764. Giessen EBW, Lamerigts NMP, Verdonschot N, Buma P, Schreurs BW, Huiskes R. Mechanical characteristics of impacted morsellized bone grafts used in revision total hip arthroplasties. J Bone Joint Surg 1999; 81-B: 1052 1057. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength. J Arthroplasty 1999; 14: 1019 1023. Verdonschot N, van Hal CT, Schreurs BW, Buma P, Huiskes R, Slooff TJ. Timedependent mechanical properties of HA/TCP particles in relation to morsellized bone grafts for use in impaction grafting. J Biomed Mater Res 2001; 58: 599 604. Dalstra M, Huiskes R. Load transfer across the pelvic bone. J Biomech 1995; 28: 715 724. Weinans H, Huiskes R, Grootenboer HJ. Effects of material properties of femoral hip components on bone remodeling. J Orthop Res 1992; 10: 845 853. Bolder SB, Schreurs BW, Verdonschot N, Unen JMJ van, Gardeniers, JWM, Slooff TJJH. Bone graft particle size and method of impaction inuence initial stability of cemented cups in bone impaction grafting. Acta Orthop Scand. Submitted. Bolder SB, Verdonschot N, Schreurs BW, Buma P. Acetabular defect reconstruction with impacted morsellized bone grafts or TCP/HA particles. A study on the mechanical stability of cemented cups in an articial acetabulum model. Biomaterials. 2002; 23: 659 666. Mallory TH, Lombardi Jr AV, Fada RA, Adams JB, Kefauver CA, Eberle RW. Noncemented acetabular component removal in the presence of osteolysis. The afrmative. Clin Orthop 2000; 381: 120128. Kuiper JH, Merry JC, Cheah K, Richardson JB. Graft composition inuences early mechanical stability in impaction grafting. Trans EORS 6th meeting Bergen, Norway, June 15 16, 1996. Malkani AL, Voor MJ, Fee KA, Bates CS. Femoral component revision using impacted morsellised cancellous bone graft. J Bone Joint Surg 1996; 78-B: 973 978. Smith EJ, Richardson JB, Learmonth ID, Evands GP, Nelson K, Lee R, Dyson J. The initial stability of femoral impaction grafting. Hip Int 1996; 6: 166 172. Eldridge JDJ, Hubble MJW, Nelson K, Smith EJ, Learmonth ID. The effect of bone chip size on initial stability following femoral impaction grafting. J Bone Joint Surg 1997; 79-B: S3 364. Wallace IW, Ammon PR, Day R, Lee DA, Beave RJ. Does size matter? An investigation into the effects of particle size on the impaction grafting in vitro. J Bone Joint Surg 1997; 79-B: S3 366. Ullmark G. Bigger size and defatting of bone chips will increase cup stability. Arch Orthop Trauma Surg 2000; 120: 445 447.

4. 5.

6. 7.

8. 9. 10.

11.

12.

13.

14.

15. 16.

17.

18.

Impaction Bone Grafting: Nijmegen Experience 19.

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20.

21.

22.

23.

24.

25.

26.

27.

Arts JJC, Verdonschot N, Schreurs B W, Buma P. Pulse lavage and larger bone graft chip size improve the initial stability of cemented cups after bone impaction grafting, J Arthroplasy, 2002, submitted Brewster NT, Gillespie WJ, Howie CR, Madabhushi SPG, Usmani AS, Fairbairn DR. Mechanical considerations in impaction bone grafting. J Bone Joint Surg 1999; 81-B: 118 124. Bavadekar A, Cornu O, Godts B, Delloye C, van Tomme J, Banse X. Stiffness and compactness of morselized grafts during impaction: an in vitro study with human femoral heads. Acta Orthop Scand 2001; 72: 470 477. Berzins A, Sumner DR, Wasielewski RC, Galante JO. Impacted particulate allograft for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of cement pressurization. J Arthroplasty 1996; 11: 500 506. Schreurs BW, Huiskes R, Slooff TJJH. The initial stability of cemented and noncemented femoral stems xated with a bone grafting technique. Clin Mat 1994A; 16: 105 110. Schreurs BW, Buma P, Huiskes R, Slagter JL, Slooff TJ. Morsellized allografts for xation of the hip prosthesis femoral component. A mechanical and histological study in the goat. Acta Orthop Scand 1994B; 65: 267 275. Schreurs BW, Huiskes R, Buma P, Slooff TJ. Biomechanical and histological evaluation of a hydroxyapatite-coated titanium femoral stem xed with an intramedullary morsellized bone grafting technique: an animal experiment on goats. Biomaterials 1996; 17: 1177 1186. Bolder SD, Verdonschot N, Buma P, Schreurs BW. The initial stability of an Exeter femoral stem after impaction bone grafting in combination with segmental defect reconstruction. J Arthroplasty 2003. In press. Verdonschot N, Huiskes R. The effects of cement-stem debonding in THA on the long-term failure probability of cement. J Biomech 1997; 30: 795802.

6
Impaction Bone Grafting
A Mechanical Appraisal with Reference to Soil Engineering
Douglas Dunlop
Southampton University Hospitals NHST Southampton, England

I.

INTRODUCTION

An understanding of the correct environment for successful grafting needs to be appreciated (Fig. 1) before good results can be achieved. In revision hip and knee surgery, large quantities of graft may be required to replace extensive bone loss. From a biological remodeling viewpoint, autograft would be the graft of choice, but it is usually precluded due to donor site morbidity in harvesting the large quantities required. The utilization of allograft bone is increasing as the number of revisions of failed joint arthroplasty rises and techniques for bone replacement gain wider acceptance [1,2]. Cadaveric harvest followed by irradiation, lyophilization, or processing and freeze-drying are used at some centers, as is the use of xenograft and synthetic materials instead of allograft. A greater understanding of the mechanical properties of the grafts would be benecial and could be analyzed along similar lines to those described in this chapter.

II.

BASIC SCIENCE

For centuries engineers have been laying foundations and building roads with variable degrees of success as far as subsidence is concerned. The most durable structures have been built on solid bedrock [3]. Properties of nonsolid materials (aggregates) used for foundations have now been dened by soil mechanical
57

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Figure 1

Remodeling of impacted graft depends upon inter-related factors.

engineers, using experimental and mathematical models of sand, gravel, and boulder mixtures. These engineers are able to predictably produce rm foundations for building support piles and embankments with minimal subsidence, based on these models. These principles are applicable to morselized bone graft aggregates (when suitably compacted in a contained environment), as the principles are largely independent of the individual properties of the particle. The relationship between density (% porosity) and material propertiesso characteristic of trabecular bonecannot be applied to morselized graft, as the graft no longer has structural continuity [4] (i.e., is not solid). The mechanical strength of morselized grafts can be determined by dynamic shear testing, either in two dimensions across a predetermined failure plane, as has been previously reported [5 7], or in three dimensions (triaxial shear testing) [8], where the aggregate is allowed to shear in its weakest plane. Because a well-compacted graft is anisotropic (properties equal in all directions), a two-dimensional testing regime can be applicable and is reported here. One disadvantage of the threedimensional (3D) method is the large amount of graft required for each test and complexities of impacting samples in an elastic membrane. III. GRADING

Production of a well-graded sample theoretically produces the aggregate most resistant to shear. This grading has been determined for spherical particles by

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Figure 2 Pyramid of spheres showing how specic smaller sizes can ll the gaps.

Fuller [9,10] and is best understood by considering the problem of making a pyramid of marbles (Fig. 2). Fuller has mathematically determined a graphic curve (Fig. 3) of particle distribution that represents the sequence of marble sizes to t the gaps, which, if carried to innitely small sizes of marbles, will allow an innitely steep pyramid to be constructed (aggregate approaches properties of a solid). When considering irregularly shaped particles, it is normal practice to use a linear log of the range of available sizes to determine an ideal mixture (Fig. 4). It is important to note that the volume of large particles is greater than that of smaller particles, even though there are fewer large particles.

IV. A.

MECHANICAL SHEAR TESTING Theory

Shear strength is one of the most important physical properties of aggregates. It is a measure of their ability to sustain stresses without failure. Preserved segmental

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Figure 3 Particle size distribution for two theoretical ideals and the three test mixtures.

bone has previously been shown to have different mechanical characteristics from fresh bone [11 15]. Previous work has been performed on formalinized bone dried after washing in acetone and alcohol. The mechanical characteristics of fresh milled human allograft from donated femoral heads have only recently been reported [6,7]. All tests in this report were performed with fresh-frozen morselized human femoral heads.

Figure 4 Theoretical relationship between bone mill size and particle size distribution (grading). The arrow indicates predicted increasing graft strength.

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The shear strength (tf) of a granular aggregate, like that of the bone graft, depends upon the angle of internal friction (f) and interlocking (c) of the particles. The frictional resistance varies in proportion to the effective normal stress (s). The relationship between these parameters can be expressed by the Mohr Coulomb failure law: tf c s tan f. The angle of internal friction (f) or angle of shearing resistance is determined mainly by the particle size distribution (grading) of a sample and, to a certain extent, on the particle shape. Steeper pyramids of aggregates can be made with improved grading, as the particle size distribution is brought closer to a theoretical (ideal) distribution, which contains particles of all sizes. The Mohr Coulomb equation for bone graft is experimentally developed through shear tests on allograft samples. The shear strength is read from the shear strain versus shear stress curves plotted for different normal stresses (Fig. 5). From the Mohr Coulomb failure law it can be seen that f can be deduced from the slope of the line (y mx c). The best-t straight-line variation between normal stress, s, and shear strength, tf , represents the Mohr Coulomb failure envelope (Fig. 6). The intersection of this line with the shear stress axis represents the interlocking of the particles (c).

Figure 5 Stress versus strain graph for a typical mixture (Mix A washed).

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Figure 6

Mohr Coulomb graph for a typical mixture (Mix A washed).

B.

Materials and Methods

Three different test groups, Mixes A, B, and C, were produced (Fig. 3) to analyze the effect of grading (Fig. 4) using 45 fresh-frozen human femoral heads, supplied by the regional bone bank: Mix ALarge average particle size and poor grading. (15 femoral heads, milled using an air-powered mill with a pair of intermeshing 8 mm teeth) Mix BIntermediate average particle size and average grading (15 femoral heads, milled using a 6 mm manual bone grater) Mix CSmall average particle size with good grading (15 femoral heads: 5 femoral heads processed through the 6 mm grater and 10 femoral heads processed through the 3 mm grater of the manual mill) The femoral heads were picked at random and thawed in warm saline. All soft tissue, cystic areas, and cortical bone remnants (e.g., residual neck and femoral calcar) were removed. The femoral heads were divided into large chunks before milling. Two different types of mill used in clinical practice were chosen to produce Mixes A and B. According to soil mechanics theory, well-graded samples of similar shapes have higher shear strength as compared to poorly graded samples [16] (Fig. 4). Based on this theory, Mix C was mathematically deduced to be a theoretical improvement in the particle size distribution, utilizing the two grater sizes3 and 6 mmprovided with mill B. The equivalent of 5 femoral heads by weight was used for sieve testing to determine the actual particle size distribution for each mill. The remaining 10 femoral heads were combined for mechanical

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testing. Each mix was evaluated 25 times, for mechanical strength after compaction, rst unwashed and subsequently after washing. All tests were performed with adherence to Health and Safety Guidelines and Universal Precautions to safeguard personnel. 1. Sieving

The particle size distribution curve for each mix was determined by sieving amalgamated graft produced from ve femoral heads (Fig. 3). Each sample was sieved according to BS 1377 guidelines. Ten sieves were used (logarithmic fractionations 0.3 8.0 mm inclusive), allowing easy manufacture of well-graded mixtures. A sample was described as well graded if there was a similar quantity of particles of each size within the range and no intermediate sizes were lacking. The upper and lower limit of sieve size matched the range of particles produced by currently available bone mills, with less than 0.1% by weight outside this range. 2. Washing Technique

A technique for washing bone graft was devised so that it could be easily performed in a sterile fashion in an operating theater. A British Standard sieve tower was made, consisting of a large sieve (2 mm) over the 300 mm sieve, which was placed over a drainage tin with suction attached (Fig. 7). The milled bone from each of the three test mills was placed onto the top sieve and washed through. The top sieve helped to hold large particles stationary during washing and prevent blocking the lower 300 mm sieve. All particles larger than 300 mm

Figure 7 (a) Washing apparatus sieving tower. (b) Washed graft trapped in upper 2 mm and lower 300 mm sieves. (c) Graft combined.

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were trapped in the two sieves. Washing was performed after the unwashed mechanical tests were completed, with warmed 0.9% saline pulse-lavaged over the graft until the graft appeared clear of macroscopically obvious fat and marrow tissue, which passed through the sieve into the suction vessel. The contents of the two sieves were then combined, and the fully saturated bone graft was then tested mechanically without removing excess 0.9% saline by absorption or centrifugation. 3. Mechanical Testing

The shear strength of all test materials was determined using the Cam (Cambridge) shear tester. The test cell was 60 mm in diameter. Previous work on impaction grafting of preserved bone utilized two currently available devices normally used for testing civil engineering aggregates such as sand or clay. These are the Proctors impactor, used to compact aggregates, and the Jenike shear tester. Their use has been described previously [5]. Modications were made to allow adequate uid drainage during compaction of wet materials. The impaction energy applied to compact each test pellet was equivalent to the energy to perform one standard femoral impaction, calculated from a simulation performed on a force plate [5]. Five samples from each of the three test groups were tested mechanically at ve different compression loads. All samples were kept at room temperature in moisture-retaining containers during the tests. 4. Sequence of Compaction

Each material to be tested was introduced into the top of the impactor (Fig. 8) in three equal portions to ensure even compaction. The compaction piston was lowered onto the sample, and the impaction weight was then dropped 24 times from the height required to deliver the desired energy. The middle and nal thirds of the test sample were then layered sequentially, and the impaction process was repeated. 5. Shear Testing

After compaction the test sample was transferred to the shearing rings. The test cell of the Cam shear tester (Fig. 9) is comprised of a xed lower ring and a mobile upper ring. The normal stress was induced by weights resting on an axial hanger. The upper ring was driven horizontally at a constant rate (strain) relative to the lower ring, applying a shear stress to the cell contents. A force transducer recorded the shearing force applied, while the displacement of one ring relative to the other was recorded with a linearly variable differential transformer (LVDT).

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Figure 8 Impactor, showing lower chamber, piston, lid, and drop weight.

To generate a family of stress/strain graphs, ve separate normal (compressive) stresses were applied and tested independently for each sample. The compressive stresses were 10 kPa (the hanger alone), 95 kPa, 180 kPa, 265 kPa, and 350 kPa (one-tenth the compressive strength of vertebral cancellous bone [17]). These stresses were chosen to produce a family of curves within the lower range of physiological compressive stress (calculated from a simple analytical model) experienced by impacted graft in the clinical setting.

6.

Sequence of Testing

The compressive load plate was placed over the test material and left to equilibrate for 5 minutes. Shearing of the test cell was commenced, recording the shearing force and displacement, from which the shear stress (kPa) and shear strain (percent) were derived after appropriate calibration. The test sample was then removed together with any lost uid and retested in the same above sequence, but with an additional compressive stress of 85 kPa. The sequence was repeated until a family of curves had been generated for the one sample up to 350 kPa compressive stress. The Mohr Coulomb failure envelope was plotted for each test, from which the shear strength and interlocking are derived.

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Figure 9

Cam shear tester before (top) and after (bottom) shear testing.

7.

Analysis of Results

The absolute values relative to previously documented results from known aggregate mixtures gave an indication of initial differences. Grouped linear regression analysis on observed means was performed to look for signicant differences at the 0.05 level.

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V. A.

RESULTS Sieving

The grading of aggregates is best determined by direct observation of their particle size distribution curve [10]. The grading curves for the different Mixes A, B, and C, as well as the curve of the theoretical variation of particle size in the range from 0.3 to 5.6 mm that will produce a well-graded mix, are shown in Figure 3. It is widely accepted that for particles of irregular shape, a well-graded mix will approach a straight line on a logarithmic grading chart. From this point of view, Mixes B and C are reasonably well graded in the particle size range of 1 5.6 mm. However, since Mix C has a larger range of particle sizes, it would be regarded as better graded than Mix B. The curve for Mix A is at in the small particle size range and rises steeply in the large particle size range. This indicates an absence of small particles and poor grading. B. Shear Testing

The shear strength increased linearly with compressive stress (R2 . 0.98) for all mixtures (Fig. 6), indicating that the grafts satisfy the Mohr Coulomb failure law well. A comparison of interlocking, shear strength at a compressive stress of 350 kPa and friction angles is given in Table 1. Larger unwashed particles tend to have increased interlocking. Washing the graft results in an increase of the

Table 1

Shear Testing Results Interlocking (kPa) Friction angle Shear strength (kPa) at s 350 kPa 212 244 208 238 282 271

Fresh graft Mix A Mix B Mix C Washed graft Mix A Mix B Mix C

10.2 20.9 21.8 7.3 13.5 13.5

29.9 35.0 30.9 33.4 37.5 36.3

Grouped linear regression analysis: Mix A washed versus Mix A fresh: p , 0.0001 Mix B washed versus Mix B fresh: p 0.0009 Mix C washed versus Mix C fresh: p , 0.0001

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corresponding friction angle for all mixes and increases the interlocking of smaller particles. Thus, at high compressive stresses an unwashed graft mix has a lower shear strength in comparison to the corresponding washed graft mix. All mixes are signicantly different from each other apart from Mix B and Mix C washed and Mix A washed and Mix B unwashed.

VI.

DISCUSSION

Recent interest in the role of contained uid within morselized graft has shown that this is an important feature when comparing samples that has often been poorly controlled for in laboratory models. It is known that granular materials can exhibit dilative or contractile behaviour on shearing, depending upon their initial density. The addition of small amounts of uid to the aggregate may be advantageous, causing an increase in the shear strength (analogous to making sandcastles). Soil mechanics theory recognizes this as a feature of suction created in the pore uid as the aggregate exhibits volumetric dilatation on shearing. However, if too much uid is present and not allowed to drain, the mechanical strength of the mixture is reduced (analogous to quicksand). Again, this is explained based on the positive pore uid pressures generated as the aggregate exhibits volumetric contraction. Tests in this report analyzed rst the role of different gradings of graft from different bone mills and second the role of different uids and their effect on mechanical strength. The role that fat and marrow uid play is affected by the choice of bone mill and by the effects of washing. Other factors also play a role and are discussed below. A. Particle Size/Choice of Bone Mill

Large series of published clinical data have shown the excellent outcome that can be achieved with specic particle sizes. In Nijmegen [18] the favored particle size for acetabular impaction grafting is large (10 mm), often with hand preparation of croutons pinched from the donated cancellous bone of the femoral head using nibblers. The Exeter group [19] recommends a particle size of 3 5 mm when performing femoral impaction grafting. This smaller size in part reects the usually smaller available space to pack graft around a revision stem, but also reects the fact that this group uses a bone mill to produce graft. They routinely use a bone mill for both femoral and acetabular impaction bone grafting. The Nijmegen group uses a bone mill for producing graft for femoral impaction grafting. According to engineering principles, to produce bone graft that is most resistant to shear (the mode of failure of impacted graft) it should not be made up

Mechanical Properties of Grafts

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of particles of a similar size, but of a broad spread of sizes [9,20]. This is highly dependent on the individual properties of each bone mill. In the clinical setting, an improvement in the spread of particles has been obtained by putting bone through two different sizes of graters or passing some of the graft through the same mill twice. Experimentally it was noted that production of a well-graded graft by adding graft from a small (3 mm grater) mill produced graft that was almost liquid in consistency [20]. This was due to the bone chips being so small that they were no longer complex cancellous chunks but simple spicules, and there was thus a greater release of fat and marrow from the interstices (Fig. 10). This may explain why some clinicians recommend the dryer larger chunks or croutons, rather than the slurry produced by these mills [21]. This also explains why Mix C, unwashed, is weaker than predicted (Fig. 4 and Table 1), but when washed regains this strength.

Figure 10 Micrograph of cancellous bone showing that uid release is dependent on particle size production.

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A recent report [22] suggested improved strength with larger bone chunks, but this was in comparison to smaller bone chunks with no control over uid release, which has been shown as an important factor. This may be because unwashed smaller particles are more difcult to impact properly due to the release of excessive fat that may not be allowed to drain away and may dampen the compactive effort. The interparticle lubrication effect may also be signicant. Experiments designed to adequately drain the graft during the compaction process show improved results for improving graft particle spread when uid content is controlled for [20]. Future test scenarios should examine the mechanical characteristics of the much larger particles or croutons used in Njimegen. From these experiments it could be hypothesized that these particles may produce their clinical success in resisting shear by releasing little uid on production and having excellent interlocking despite their poor grading. A direct comparison with these data would be most illuminating. Croutons are undeniably effective clinically on the acetabular side as shown by Slooff et al., and the graft may well be behaving as a collection of mini structural allografts. The theoretical improvements in particle size may only be worth pursuing on the femoral side (where there is insufcient space for the larger croutons), as the detrimental effects of uid release are more relevant. Of further interest is the grater design, as some mills produce rod-like shapes (Noviomagus), which theoretically may have a function rather like the metal rods in reinforced concrete. The transition from spongy cancellous particles to individual solid particles is bound to also play a major role in the further analysis of graft material.

B.

Washing the Graft

The effect of particle size cannot be considered alone as it is intimately related to uid release. Removing excessive and lubricating uid from the interstices of graft for impaction grafting improves the overall graft strength [6,20]. This is advantageous and based on sound engineering principles [9,10]. In the clinical scenario it was also found to be a useful way to examine the graft to remove rubbish such as cystic material or pieces of articular cartilage, which might cause focal defects in the impacted mantle (Fig. 11). The improvement in strength is due to an increase in the friction angle. This is thought to be due to the removal of the fat and marrow tissues, allowing tighter graft compaction. The particles when washed and dried have little lubrication at the contacts with other particles, so the frictional resistance will be higher. However, with lubrication in the form of fat and marrow at the contacts, the frictional resistance will be reduced.

Mechanical Properties of Grafts

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Figure 11

Removal of deleterious cystic material in a human operative case.

C.

Immunogenic Load and Growth Factors

There will potentially be more interparticle spaces empty of dead foreign tissue available for faster invasion by host angioneogenesis. The removal of fat and marrow tissue from allograft, which is foreign to the host, may have the additional benet of reducing the immunogenic load experienced by the host, damping the initial inammatory phase of graft incorporation [23 27]. Whether the potential reduction in the level of growth factors present in the washed graft matrix is important is currently a matter for investigation. Previous work has questioned the activity of donor graft growth factors [28 30]. Ultimately the graft may be incorporated primarily by an increased expression of host growth factors, analogous to fracture healing [27]. Immunogenic incompatability between donor and recipient is attenuated by the act of freezing. The marrow elements within the cancellous bone are thought to be responsible for the majority of this immunogenicity [26] and in the past have been recognized as only a minor problem [23,24,31,32]. There has been recent interest in the detrimental effect of this immunogenic response [26,27,33 37], with a number of authors already reporting improved incorporation and biomechanical performance with washed [38] or histocompatability-matched grafts [4].

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D.

Cartilage

Cartilage has an adverse effect if it has not been removed from the femoral head prior to milling [39,40]. In the large reported clinical series the cartilage has usually been removed (chondral abrasion using an oscillating saw prior to milling or never included due to the use of a rongeur), although this has not been a widespread clinical practice in other centers. E. Compaction Energy

Adequate compaction can only occur when rigidly contained with adequate drainage. This allows enhanced density of graft with a reduction in porosity and increase in shear resistance. During surgery, the decision as to when the graft is suitably compacted is subjective, and attempts are underway to quantify this (J. Richardson, personal communication, 2001). Bone graft exhibits strain hardening at increasing compactive effort [5], and previous experiments on bovine bone have shown the clear advantage of using increasing compactive effort. Aggressive compaction is required, and on the femoral side completion can be gauged, when the phantom impactor is rmly seated, requiring a mallet to extract it. A more reproducible and accurate measure may be when the line on the guidewire reaches the mark in the window of the phantom and will not subside further despite 10 standard mallet blows [20].

VII.

SUMMARY

To produce an aggregate (milled bone graft) most resistant to shear stress, it should: Be rigidly contained Have a well-graded particle size distribution (mostly large particles by volume, but also smaller, ller particles) Be porous to allow uid escape and thereby minimize any pore uid generation Have sequential layered compaction of well-mixed material Use large compaction energies Possibly be washed

REFERENCES
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Stockley I, Holt G. Provision of allograft bone for orthopaedic surgery: a census of orthopaedic surgeons. Br Orthop News 1998; 18: 24 25. The Holy Bible. 2000; Matthew 7: 24 27. Davy DT. Biomechanical issues in bone transplantation. Orthop Clin North Am 1999; 30: 553 563. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR. Mechanical considerations in impaction bone grafting. J Bone Joint Surg (Br.) 1999; 81: 118 124. Dunlop DG, Howie CR, Madabhushi SP, Usmani AS. Factors inuencing impacted bone graft strengthto wash or not to wash? J Bone Joint Surg (Br.) 2000; 82(suppl I): 78. Dunlop DG, Howie CR, Pankaj P, Madabhushi SP, Usmani AS. The biomechanics of impaction grafting during revision hip surgery. 4th Europ Fed Nat Assoc Orthop Traum (EFORT) Conference Proceeding, Brussels, Belgium, June 2 6, 1999. Brodt MD, Swan CC, Brown TD. Mechanical behavior of human morselized cancellous bone in triaxial compression testing. J Orthop Res 1998; 16: 43 49. Craig RF. Soil Mechanics. London: Chapman and Hall, 1993. Smith GN. Elements of Soil Mechanics. Oxford: Blackwell Science Ltd, 1990. Linde F. Elastic and viscoelastic properties of trabecular bone by a compression testing approach. Dan Med Bull 1994; 41: 119 138. Linde F, Sorensen HC. The effect of different storage methods on the mechanical properties of trabecular bone. J Biomech 1993; 26: 1249 1252. Nafei A, Danielsen CC, Linde F, Hvid I. Properties of growing trabecular ovine bone. Part I: mechanical and physical properties. J Bone Joint Surg (Br.) 2000; 82: 910 920. Nafei A, Kabel J, Odgaard A, Linde F, Hvid I. Properties of growing trabecular ovine bone. Part II: architectural and mechanical properties. J Bone Joint Surg (Br.) 2000; 82: 921 927. Rohl L, Larsen E, Linde F, Odgaard A, Jorgensen J. Tensile and compressive properties of cancellous bone. J Biomech 1991; 24: 1143 1149. Lambe TW, Whitman RV. Soil MechanicsSI Version. London: John Wiley & Sons, 1979. Amis AA. Biomechanics of bone, tendon and ligament. In: Hughes S, McCarthy I, eds. Sciences Basic to Orthopaedics. London: WB Saunders Company Ltd., 1998. Schreurs BW, Slooff TJ, Buma P, Gardeniers J, Huiskes R. Acetabular reconstruction with impacted morsellised cancellous bone graft and cement. A 10- to 15-year follow-up of 60 revision arthroplasties. J Bone Joint Surg (Br.) 1998; 80: 391 395. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg (Br.) 1993; 75: 14 21. Dunlop DG. Mechanical and biological aspects of impaction bone grafting in revision hip surgery and the use of a new synthetic bone graft. Thesis/Dissertation, University of Edinburgh, Edinburgh, 2001. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Contained morselized allograft in revision total hip arthroplasty. Surgical technique. Orthop Clin North Am 1993; 24: 717 725.

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Dunlop Sommers JFA, Timperley AJ, Wendover N, Gie G, Ling RS. Impaction grafting in cemented revision surgery of the acetabulum. J Bone Joint Surg (Br.) 1999; 81: 217. Bonglio M, Jeter WS. Immunological responses to bone. Clin Orthop 1972; 87: 19 27. Burchardt H, Enneking WF. Transplantation of bone. Surg Clin North Am 1978; 58: 403 427. Goldberg VM, Stevenson S. Natural history of autografts and allografts. Clin Orthop 1987; 225: 7 16. Whiteside LA. Cementless xation issues in revision total knee arthroplasty. Instr Course Lect 1999; 48: 177182. Tagil M. The morselized and impacted bone graft. Animal experiments on proteins, impaction and load. Acta Orthop Scand Suppl 2000; (290): 1 40. Urist MR. Bone: formation by autoinduction. Science 1965; 12:698: 893 899. Burwell RG. Studies in the transplantation of bone: V. The capacity of fresh and treated homografts of bone to evoke transplantation immunity. J Bone Joint Surg (Am.) 1963; 65: 239 246. Burwell RG. Studies in the transplantion of bone: VII. The fresh composite homograft-autograft of cancellous bone. An analysis of factors leading to osteogenesis in marrow transplants and in marrow-containing bone grafts. J Bone Joint Surg (Br.) 1964; 46: 110 140. Ray RD. Vascularization of bone grafts and implants. Clin Orthop 1972; 87: 43 48. Goldberg VM, Powell A, Shaffer JW, Zika J, Bos GD, Heiple KG. Bone grafting: role of histocompatibility in transplantation. J Orthop Res 1985; 3: 389 404. Dunlop DG, Griffon D, Howie CR, Madabhushi SP, Usmani AS, Gillespie WJ. An ovine model to evaluate impacted pellets of new synthetic bone graft substitutes. J Bone Joint Surg (Br.) 2000; 82(suppl 1): 65 66. Aspenberg P, Tagil M, Kristensson C, Lidin S. Bone graft proteins inuence osteoconduction. A titanium chamber study in rats. Acta Orthop Scand 1996; 67: 377 382. Horowitz MC, Friedlaender GE. Immunologic aspects of bone transplantation. A rationale for future studies. Orthop Clin North Am 1987; 18: 227 233. Stevenson S, Li XG, Martin B. The fate of cancellous and cortical bone after transplantation of fresh and frozen tissue-antigen matched and mismatched osteochondral allografts in dogs. J Bone Joint Surg (Am.) 1991; 73: 1143 1156. Muscolo DL, Caletti E, Schajowicz F, Araujo ES, Makino A. Tissue typing in human massive allografts of frozen bone. J Bone Joint Surg (Am.) 1987; 69: 583 595. van der Donk, S. Experimental and clinical data on the incorporation of impacted morsellized bone grafts. Thesis/Dissertation, University of Nijmegen, Netherlands, 2002. van der Donk S, Buma P, Slooff TJ, Gardeniers JW, Schreurs BW. Incorporation of morselized bone grafts: a study of 24 acetabular biopsy specimens. Clin Orthop 2002; 396: 131 141. Bavadekar A, Cornu O, Godts B, Delloye C, Van Tomme J, Banse X. Stiffness and compactness of morselized grafts during impaction: an in vitro study with human femoral heads. Acta Orthop Scand 2001; 72: 470 476.

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7
Stability of Impaction-Grafted Hip and Knee Prostheses: Surgical Technique, Implant Design, and Graft Compaction
Jan Herman Kuiper and James Richardson
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital Oswestry, Shropshire, England and Keele University Keele, Staffordshire, England

Ayman Soliman
The Robert Jones and Agnes Hunt Orthopaedic and District Hospital Oswestry, Shropshire, England

Kevin Cheah
Springeld Hospital, Chelmsford, Essex, England

I.

INTRODUCTION

Potential early problems of impaction grafting relate to subsidence of the prosthesis, which may be related to surgical technique (impaction, stem positioning, cementation), graft quality, host bone quality, and stem design. Eldridge et al. studied 79 consecutive revision hip arthroplasties using morselized allograft, bone cement and a double tapered, polished, collarless stem [1]. They reported nine cases of massive subsidence (.10 mm) on the femoral side, which they attributed to varus alignment of the stem. Franzen et al. used radiostereometric analysis (RSA) in a small series of six hips in ve patients followed up to one year [2]. They found one-year subsidence of 0.4 2 mm in ve out of six hips and 4.9 mm in the sixth. They supposed that insufcient distal compaction had caused the extra subsidence of the sixth hip.
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While these studies stress the importance of surgical technique, others mention the importance of stem geometry to the ultimate outcome [3]. These workers used double tapered polished Exeter stems and reported subsidence of 5 10 mm in 11 of 56 patients followed up between 18 to 49 months. In a recent clinical follow-up, Gokhale et al. reported on migration of three stem types in 56 patients [4]. They correlated stem migration with prosthesis type and various factors characterizing aspects of the surgical technique or patient population. Only variations in stem angulation could be predicted by these factors. They found that angulation was not a matter of type, technique, or patient, but that all three aspects were simultaneously important. Laboratory experiments are probably better suited than clinical studies to determine which of the factors that make up surgical technique and prosthesis type are important, since all other variables can be kept constant. Even a study conned to surgical technique and implant variations still needs to investigate many separate factors, since a description of technique or design requires a multitude of separate factors. For instance, surgical technique comprises impaction itself (e.g., degree of compaction or evenness of impaction) and stem insertion (e.g., stem angulation or positioning). Likewise, stem design comprises for instance geometry, material properties, and surface nish. Investigating multiple factors acting simultaneously is a common problem. Efcient methods to cope with this problem have been developed in a branch of statistics known as design of experiments (DOE) (see e.g., Ref. 5). The recommended approach according to DOE is a two-stage one. Stage one is the screening stage, in which all factors are efciently varied such that a minimum number of separate experiments can identify the effect of each factor. In this chapter we use an in vitro model of hip stem impaction grafting for this purpose and will nd that graft compaction is probably the single most important factor. Stage two is the analysis stage, in which the factor(s) found in stage one are further analyzed using more elaborate specic models. In this chapter we will show further experimental evidence that graft compaction is indeed likely to be an important factor also for impaction grafting of tibial trays. In the nal section of the chapter we will discuss the reasons for and the implications of the importance of compaction.

II. A.

IN VITRO SAWBONE EXPERIMENTS Factors Controlling Early Migration of Impaction-Grafted Prostheses

Many factors could inuence early migration of impaction-grafted stems. Those most under direct inuence of the orthopedic surgeon, and thus most relevant, are probably operative technique and stem design. However, even a single item such

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as technique hides a larger number of factors, such as angle of insertion, position of the cement restrictor, and graft compaction. To nd out which of these many factors is most relevant, we performed a screening experiment in which all factors were varied systematically such that the various factors are not correlated with each other. By doing so, the factors can be used as predictors in a regression analysis with stem migration as outcome. However, systematically varying aspects of surgical technique might be difcult because surgeons would be forced to use an unfamiliar technique. Instead, we ensured a large spread of surgical techniques by asking a large number of surgeons (n 9) to perform the operations. Because we were not interested in the individual surgeons ability to perform the operation, we measured factors that characterized the surgical technique and did a regression analysis afterwards to check whether these factors were uncorrelated. 1. Methods and Results

Briey, the experiment used glass epoxy femora which were prepared by removing the femoral head and all core material such that only a cortical shell remained (Mallory type II defect). Surgeons then inserted a cement restrictor, impaction-grafted human morselized bone into the cavity and cemented a femoral component in place. Four types of implants and matching instruments were used (Charnley Elite, Exeter, Ultima, and Stanmore). Surgical technique was characterized from AP and ML x-rays taken after implantation by measuring stem orientation in frontal and sagittal plane, height of the implant on insertion, and distance between stem tip and cement plug. The density of the graft at two locations (distal to the tip and at the calcar) was characterized by determining the ratio of local gray level to that of the medullary cortex of the Sawbone on the same x-ray. The bone with prosthesis was then positioned in a jig to ensure physiological loading directions for the prosthetic head and the greater trochanter, placed in a testing machine, and cyclically loaded up to a joint force of 2500 N. Movements of the prosthesis relative to the bone were measured at the proximal level. During the 100 cycles that the test lasted at each load level, the curve for each movement component resembled a logarithmic function of time (Fig. 1). Predominant movements of all stems were translation in longitudinal direction, rotation around the longitudinal axis (retroversion), and rotation around the A/P axis (varus/valgus). Average subsidence at 2.5 kN ranged from 0.20 mm for the Stanmore to 0.80 mm for the Ultima stems. Rotation around the longitudinal axis for all stems except one was to retroversion and ranged from 0.188 for the Charnley to 0.478 for the Stanmore stems. Based on the observation that subsidence followed a logarithmic function of time, we extrapolated from the 100 cycles forming the subsidence curve at 2.5 kN (+3.5 times body weight) to

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Figure 1 Typical pattern of subsidence as function of time at three load levels. Raw data and tted logarithmic curve are shown for an Ultima stem.

1 million cycles, equivalent to one year. The predicted average subsidence at one year ranged from 0.38 mm for the Stanmore to 1.39 mm for the Ultima stem. We then used regression analysis to determine whether stem type and technical factors had a strong inuence on migration of the implants, and which technical factor in particularinsertion or bone density. Prosthesis type and values of technical parameters (stem orientation on AP and ML x-ray, stem position, cement plug position, and proximal and distal graft density) were used as independent variables (predictors). Migration values were used as dependent variables (outcomes). Unfortunately, the technique-related predictor factors were not equally spread over the four stem types. The implication is that the regression analysis could have difculties to distinguish between prosthesis type and surgical technique as predictor variable. Stem subsidence after 100 cycles at 2500 N could be predicted equally well by stem type (r 2 0.69) and bone density around the tip of the implant (r 2 0.70) (Fig. 2). Similar results were found for prediction of stem subsidence extrapolated to 1 million cycles (stem type: r 2 0.67; tip density: r 2 0.78). All these correlations were highly signicant, even after adjusting for the fact that we tested seven predictors. Because the Ultima stem showed a signicantly lower distal graft density and higher subsidence than the other stems, it might skew the results. Without the Ultima, distal graft density was equally spread over the stem types. No good predictor for subsidence after 100 cycles was found. However,

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Figure 2 Relation between distal graft density, which reects rmness of impaction, and stem subsidence extrapolated to one million cycles (one year) at 2500 N. The open squares denote the results for the Ultima stem.

estimated subsidence at 1 million cycles correlated strongly with distal graft density (r 2 0.50, p 0.02) and less with prosthesis type (r 2 0.20, p 0.19). Varus rotation correlated with prosthesis type (r 2 0.55) and orientation in the sagittal plane (r 2 0.56). In this case, only the correlation with orientation was signicant. Variations in retroversion did not correlate with any factor. However, close inspection of the scatter plots revealed one outlier. Leaving it out showed that retroversion correlated well with prosthesis type (r 2 0.49) and particularly stem orientation in the sagittal plane (r 2 0.66). Only the correlation with orientation was signicant. 2. Conclusion

Clearly, the above screening experiment suggests that technical factors are strong determinants of early stem migration. Stem subsidence was largely predicted by graft density, which is a measure of graft compaction achieved by the surgeon. Varus rotation and retroversion were both predicted by stem orientation at insertion. We decided to focus the remainder of the work in particular on graft compaction, evidently the distinctive feature of impaction grafting. B. Graft Compaction as the Main Determinant of Early Implant Stability

Both centers that pioneered impaction grafting recommend vigorous impaction [3,6]. Two Scandinavian studies in which stem migration is monitored using RSA

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propose lack of sufcient compaction as the most likely explanation for substantial migration [2,7]. Although it evidently makes sense that more vigorous impaction improves implant stability, none of these authors provide direct data indicating how important impaction is. The above screening experiment gives some indication of the importance: between 50 and 80% of the variation in subsidence could be explained by density of the compacted graft or, in other words, level of graft compaction. It was, however, a study of many factors acting simultaneously. Moreover, graft density was measured from normal x-rays, which may not be an ideal method. We therefore decided to perform more experiments aimed directly at assessing the inuence of graft compaction on early implant stability. The rst experiment uses an alternative method to assess degree of graft compaction. The problem of deciding whether an object has been hammered down enough to support a load is not unique to orthopedics. The same problem occurs during production of piled foundations for constructions on weak soil. One needs to know at what point a pile has been driven down sufciently to support the load of the construction without risk of subsidence. One method used to assess loading capacity of driven piles is based on an energy balance [8 10]. The energy generated by the dropping pile hammer is converted to elastic energy (e.g., elastic compression of the pile) and an amount of work performed by the resisting force (i.e., loading capacity) of the pile. The latter amount is equal to the product of resisting force and permanent displacement of the pile or set [9,10]. In the most basic approach to calculate loading capacity of a pile, the loading capacity is calculated as the ratio of hammer energy and set. We hypothesised that impaction set (sinkage of the tamp per hammer blow) would be a direct characterization of the rmness of impaction achieved. The aim of the study was therefore to test that rmness of impaction is a major factor determining early stem migration by correlating impaction set with stem migration under load. As a second aim, we tested again the importance of stem design relative to rmness of impaction by using widely differing stem designs in the study. The second experiment was aimed at determining whether graft compaction was also a major determinant of implant stability in replacements of other joints than the hip. For this purpose, we used an in vitro model of proximal tibial joint replacement. Instead of x-rays, we used DXA scans to determine density of the compacted graft. 1. Methods and Results

For the hip joint experiments, the same model of a Mellory Type II defect was used as explained above. Two femoral stems were compared: the Stanmore (n 4) and the Taperloc (n 5) femoral stem (both Biomet-Merck, Bridgend, UK). The Stanmore is a collared cobalt-chromium stem, which has a tapered

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Figure 3 An implanted Stanmore (left) and Taperloc (right) femoral stem following impaction grafting using morselized bone.

curved stem, rounded medially and laterally. The Taperloc is a collarless titanium stem, with a plasma-spray coating covering the proximal 40% of the stem. The stem has a tapered rectangular shape, very different from the Stanmore (Fig. 3). Two experienced surgeons performed the impaction. They used their experience to decide when compaction was sufcient. At that point, ve standardized impulses were generated on the nal tamp by dropping the slaphammer, which is part of the instrumentation set. This hammer has a mass of 0.806 kg and drops from a height of 0.174 m, providing an amount of energy at impaction of 1.38 Nm and an impulse of 1.49 Ns. The sinkage per blow (or set) of the tamp into the canal during these impacts was measured using a linear potentiometer (Sakae Tsushin Kogyo Co, Kawasaki, Japan) (Fig. 4). The average sinkage of the tamp per blow, or the impaction set, varied from 0 to 70 mm. The set did not differ signicantly between the prosthesis types (mean difference 7 mm; 95% C.L. 243 to 58 mm). During cyclical loading,

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Figure 4

Experimental set-up for measuring set during impaction.

predominant movements of the stems were translation in longitudinal direction (subsidence) and posterior direction and rotation around the longitudinal axis. Average subsidence at 4 kN was 0.45 mm for the Stanmore and 0.05 mm for the Taperloc stems. Average posterior translation was 0.21 and 0.33 mm, respectively. The average total translation, which is the vector sum of all three components of translation, was 0.61 and 0.40 mm, respectively. Subsidence correlated poorly with set (r 0.10). However, total translation correlated highly with set (r 0.94; 95% C.L. 0.75 1.00) (see Fig. 5). A small difference in total translation (0.20 mm) was found between the stems, which was not signicant (95% C.L. difference 20.28 to 0.69 mm; p 0.36). When we repeated the analysis with impaction set as a covariate (ANCOVA), the corrected difference was smaller (0.12 mm), but still not signicant ( p 0.098). For the knee joint, eight articial proximal tibiae were produced using a rapid prototyping process. The cortex was replicated only, and the overall elastic properties were similar to those of human tibiae. The medullary bone stock was restored using impaction grafting of human morselized bone. Tibial trays (PFC-Sigma, Johnson & Johnson/DePuy, Leeds, UK) were cemented in place, ensuring full cortical support for four implants and support by impacted graft

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Figure 5 Stem translation after 100 cycles at 4500 N versus impaction set for the two stems. The best-t line and its 95% condence limits are shown. Open circles represent the Stanmore stem, and closed squares the Taperloc stem.

particles only for the remaining four. DXA was used to determine bone density (g/cm2) of the compacted graft and was measured in the tip region of the stem and proximally underneath the tray both medially and laterally. The trays were loaded with 100 cycles each of 500 N on the medial side, 500 N on the lateral side, increasing in steps of 500 N up to 1500 N. The tray movement relative to the cortical bone was measured in 6 D.O.F., and the data converted to maximum total cyclic and permanent displacement. Density of the impacted graft ranged from 1.04 to 1.25 g/cm2 proximally and from 0.96 to 1.85 distally in the tip region. Variations were therefore much larger distally. Implant movement was a combination of subsidence and toggling. Similar to femoral hip implants, resulting total displacement was a logarithmic function of time. Medial loading caused largest movements. Maximum permanent displacement varied from 0.8 to 4.6 mm for nonseated and 0.5 to 1.1 mm for seated implants. Cyclic total displacements varied from 0.47 to 0.79 for nonseated and 0.26 to 0.52 for seated implants. For both permanent and cyclic displacement, the mean difference between the two was small (1.6 mm, p 0.17 and 0.22, p 0.05 mm, respectively). However, when corrected for graft compaction characterized by DXA, mean differences were larger and highly signicant (3.1 mm, p 0.0006 and 0.35 mm, p 0.007) (Fig. 6). When adjusted for implant seating, there was a signicant correlation between distal graft com-

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Figure 6 Maximum total permanent movement of tibial trays xed by impaction grafting. Two groups of trays are compared: those with full cortical support (seated) and those without, (unseated). See text for further explanation.

paction and both permanent displacement (r 20.94, p , 0.002) and cyclic displacement (r 20.77, p 0.04) (Fig. 2). 2. Conclusion

Further Sawbone experiments on both hip and knee implants conrm the conclusion of the screening experiment, namely that early implant stability is in large part inuenced by graft compaction. Graft compaction is at least partly under the control of the surgeon: more vigorous impaction will lead to more compaction, which will increase stability. In addition, these experiments have demonstrated a feasible method for intraoperative prediction of early implant stability, namely by measuring impaction set.

III.

WHY IS GRAFT COMPACTION IMPORTANT?

Compaction is dened as an increase in bulk density (mass per unit volume) and a decrease in porosity resulting from applied loads, vibration, or pressure. More compacted soils (or other materials) can support greater loads (load-bearing capacity). Bulk density can be increased by controlling the moisture content, compaction forces and treatment procedures, as well as by manipulating the type

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Figure 7 Compaction curve of morselized cancellous bone, comparing bone before and after impaction. Note logarithmic scale for stresses.

of material being compacted [11]. Clearly, graft compaction is exactly what a surgeon achieves and probably aims for during impaction grafting.

A.

Compaction by Impaction: The Compaction Curve

Why compaction is so important can be understood from a compaction curve of morselized bone (Fig. 7). This graph was produced by compacting small samples of morselized human trabecular bone in a cylindrical mold using a materials testing machine and shows the stress needed to compact morselized bone a given percentage. Notice the line curves strongly upwards, so every extra compaction has an increasing yield in terms of graft strength and load-bearing capacity. The graph also shows that morselized bone can be compacted to become a very strong material: stronger than intact cancellous bone (typical strength 4.2 MPa; [12]) and certainly stronger than the average compressive stress levels around cemented stems (0.5 MPa; [13]). The same graph also shows the compaction curve of bone samples that have received 20 standardized hammer impacts by dropping a 0.7 kg weight from 10 mm. For large loads, the curve follows the same path as the noncompacted graft. However, for smaller loads the compacted graft is stiffer and deforms less. A more compacted graft will therefore reduce migration of the implant. To understand better what happens during graft compaction by impaction, we used the same set-up as above to compact graft into a cylindrical mold using standardized impulses, while measuring displacement of the plunger. The

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Figure 8 Displacement pattern of a plunger impacted onto a mass of morselized cancellous bone.

displacement pattern of the plunger (Fig. 8) is similar to that of a pile during pile driving [14]. Upon impact, the plunger is forced down by the hammer, deforming the graft. After a short period (typically 10 msec), maximum deformation is achieved and the graft partly recovers. During pile driving, this pattern is caused by elastic compression of the pile and permanent sinkage (set) of the pile in the ground. It forms the basis of calculating load-bearing capacity of piles from the set, as mentioned in the previous section. This same pattern during graft impaction is most likely caused by graft deformation, which is partly elastic and partly plastic or permanent. The latter component is equivalent to the impaction set we referred to in the previous section. Typically, with each consecutive hammer blow the set reduces and the elastic deformation increases. This pattern can be readily understood from the compaction curve (Fig. 7). Upon impact, the kinetic energy of the hammer is converted to elastic energy of the graft, which can be measured as the area under the curve. At rst impact, the energy will be the area under the curve AB (Fig. 9). However, the graft is elastic and rebounds to C. This complete event takes approximately 10 msec. The permanent displacement of the impactor, AC, is the set. At the second impact, the impactor rst travels along line CB and then follows further the compaction curve up to point D. The area under CBD is again the kinetic energy of the hammer. The graft then rebounds to E. The permanent

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Figure 9 Thick line represents compaction curve of morselized cancellous bone. The letters and thin lines demonstrate events during impaction. See text for further explanation.

displacement at second impaction, CE, is smaller than AC. In other words, the impactor set becomes smaller at each subsequent impaction. On the other hand, the elastic deformation at the second impact (DE) is larger than at the rst impact (BC). In the cylindrical mold with at impactor, this process continues until the point where all hammer energy is used to elastically compress the graft up and down (line FG) and no further compaction occurs: the impactor set is zero. Depending on the compaction curve, this occurs after approximately 20 blows. In this situation, the only way to achieve more graft compaction is to apply more energy per impact, i.e., impact more vigorously. In the cylindrical mold, the direction of compaction coincides with the main direction in which the impactor moves. Compaction by impaction in that case readily leads to the point where all further impaction only yields elastic compression of the graft and no further permanent compaction (zero set). Impaction grafting for acetabular revision is probably the most appropriate clinical example of this situation. During impaction grafting for hip revision, the tamp can, however, act as a wedge and gives compaction in a direction perpendicular to the movement of the impactor. Elastic rebound of the graft would require the tamp to be pushed out by the graft, which is less easy because the main directions of graft pressure and tamp movement are perpendicular. A situation of zero set may therefore not occur as readily, which probably explains why impaction set is such a good predictor of early hip stem stability.

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B.

Bone Density, Particle Size, and Impaction-Compaction

In the previous section we showed how more vigorous impaction increases graft compaction and in this way will improve implant stability. Another way in which implant stability would improve is use of morselized graft with a steeper compaction curve. Even with the same hammer energy, such a graft would be compacted to a stronger material since the hammer energy would be used more efciently. Among factors that could inuence the steepness of the compaction curve are graft characteristics such as donor bone density and particle size. It stands to reason that denser donor bone will produce stiffer and stronger graft. Increasing particle size has also been shown to increase the stability of impaction-grafted components, although not every surgeon would benet equally [6]. To determine the effects of these two factors on graft compaction, we performed a study using uniaxial compaction. Bone samples with a range of densities and sizes were compacted in a cylindrical mold using 20 blows of a 0.7 kg hammer dropping from 10 mm while measuring the position of the plunger. Bone mineral density (BMD) was determined using DXA and particle size distribution using image analysis of a digitized contact x-ray showing individual bone particles. In all cases, a straight line could be tted between the logarithm of blow number and plunger position, clearly demonstrating how each consecutive blow produces a smaller plunger displacement or set and thus increases bearing capacity. Earlier in this chapter, we showed that identical implant stability requires identical set. The linear t between logarithm of blow number and plunger position allows calculating the number of blows needed to achieve an identical set for each bone sample. This number turns out to be proportional to the slope of the linear t. This is logical: a steeper slope denotes a larger set at identical blow number, and thus more blows are needed to reduce the set to an acceptable level. Since the slope itself is proportional to the plunger sinkage, it follows that the total number of blows required is proportional to plunger sinkage after a given number of blows. A plot of plunger sinkage as function of particle size and bone density clearly shows the interaction between the three (Fig. 10). Compared to large particles of high bone density, plunger sinkage increases for smaller particles or donor bone of lower density. The difference is largest when small particles from low-density donor bone are used, when sinkage is about four times as much. Such particles would therefore need four times as many blows to achieve similar bearing power, in other words, they have a low impaction efciency. The difference in bearing power between the two would be particularly clear when the surgeon impacted less vigorously. Delivering more energy per hammer blow will always give more compaction and is thus more likely to give sufcient bearing

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Figure 10 Total sinkage of plunger into a mass of morselized cancellous bone after 20 standard blows as a function of host bone density and characteristic particle diameter. Dots represent data points, and the curved surface is a thin plate spline interpolant.

power whatever the graft quality. That surgeons who impact less vigorously benet more from larger particles was indeed shown in an in vitro experiment [6]. Donor bone is often in short supply, which makes it difcult to reject lowdensity bone beforehand. To ensure good impaction efciency, it thus seems advisable to avoid morselizing them into small particles.

IV.

DISCUSSION

This chapter presents two major messages. First, for medullary defects of either proximal femur or proximal tibia, migration of the prosthesis is mainly a function of technical aspects of the operation, in particular graft compaction achieved. Graft compaction around hip stems proved a stronger predictor of subsidence than stem design. Moreover, we demonstrated that early subsidence could be predicted by measuring the set of the impactor during impaction. Second, both donor bone density and particle size inuence the amount of effort required by the surgeon to achieve sufcient compaction to ensure implant stability. Lower donor bone density and smaller particles increase effort to compact by as much as four times. Many factors can play a role in determining subsidence levels. They can be related to patient activity, host bone quality and geometry, graft, surgical technique, and stem design. This chapter concentrated on the last three because they are most readily inuenced by the surgeon. However, geometry and quality of host bone and geometry and patient activity will clearly be important too.

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Major complications with the technique of impaction grafting seem mainly related to fractures of the host bone, whether intraoperatively or later, suggesting that host bone quality may well be the most important clinical factor [15]. However, many intraoperative fractures can probably be avoided by applying cerclage wiring prophylactically [4,7,16,17]. Restricting attention to donor graft, surgical technique, and implant design, this chapter provides strong evidence to suggest that technical aspects of the operation form the major factor determining early stability of impaction-grafted implants among these three, in particular the degree of graft compaction achieved. Many authors have stressed the importance of impaction vigor. In their original paper on impaction grafting for femoral components, Gie et al. [3] recommend vigorous impaction and comment on the impressive stability that can be achieved in this way. In their recommendations, Schreurs et al. [6] stress that it is imperative that the grafts be impacted very vigorously. Two Scandinavian studies in which stem migration is monitored using RSA propose lack of sufcient compaction as the most likely explanation for substantial migration [2,7]. Ornstein et al. [18] found that a considerable amount of migration of impaction-grafted implants occurs during the rst week after surgery, which they regard strong evidence of graft compaction due to patient activity. The importance of graft compaction is therefore supported by much circumstantial evidence, and clearly has a strong logical appeal. However, the work summarized in this chapter provides the rst direct research into the importance of graft compaction compared to other factors. Using density of compacted graft as a measure of graft compaction, 70% of variation in stem subsidence was explained by graft compaction. With impaction set, the sinkage of the impaction tamp per standard blow, as a more direct measure of impaction vigor, almost 90% of variation in stem migration could be explained. In both sets of experiment, hip implants of widely differing design were used. A similar dependence of implant migration on graft compaction was found for tibial trays. Moreover, we demonstrated that donor bone quality and particle size of the morselized graft inuence the impaction efciency of the graft, i.e., the number of blows required to achieve sufcient bearing strength. Donor bone of low density milled into small particles requires up to four times as many blows to compact to a comparable strength level. A. Risks of Increased Compaction

Sufcient graft compaction is clearly important to ensure that the graft is sufciently strong to carry the implant load. Thus, a denite risk of undercompaction exists. Is there also a risk of overcompaction? Probably the most important risks of increased compaction are decreased porosity of the impacted graft, possibly leading to reduced bone formation and cement penetration and

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host bone fracture. As indicated earlier, prophylactic wiring may be needed to prevent host bone fracture. In addition, the work presented here has indicated a trade-off between hammer impulse and required number of blows, in particular for tapered stems. If host bone fracture were associated with high-impulse hammer blows, then using less vigorous blows but applying more of them would be a solution. However, this association does not necessarily exist because wedging by the tamp could also cause host bone to fracture. Clearly, more research is needed to clarify this aspect. Whatever the cause, quantication of degree of compaction achieved, for instance by measuring impaction set, may provide a way to standardize compaction and reduce the risk of fracture. Graft compaction will also reduce the porosity of the graft. Reduced porosity may make it more difcult for new bone to grow into the compacted mass. Tagil and Aspenberg [19] compared bone ingrowth into noncompacted and compacted bone and found that compaction reduced ingrowth. Pratt et al. [20] compared bone ingrowth into compacted material with an ideally graded particle size distribution (a distribution that ensures at each level that voids between larger particles are lled with smaller particles) and a nonideally graded one (leaving more open voids). They found more ingrowth into the nonideally graded graft, again suggesting that reduced graft porosity may decrease bone ingrowth. A second effect of smaller graft porosity may be to reduce its permeability to bone cement, giving less cement penetration. For primary implants, cement/bone interdigitation is regarded important to ensure good xation. The optimum level is under debate, but 3 4 mm has been suggested as a reasonable compromise [21]. Although level of cement penetration inuences early stability of impaction-grafted stems only marginally [22], it may well become important after replacement of the graft by new bone. We have therefore investigated the

Figure 11 Cement penetration into a mass of morselized cancellous bone after compaction with 20 standard blows as a function of amount of compaction and characteristic particle diameter. Dots represent data points, and the curved surface is a thin plate spline interpolant.

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inuence of effective particle size and amount of compaction on cement penetration by forcing cement into the compacted mass at a standard pressure of 200 kPa, which is a typical level [23]. The experimental set-up was the same as in the previous section, and the amount of compaction was characterized by total plunger sinkage. Within the range of particle sizes that we studied (3.2 6.3 mm), cement penetration ranged from 2.4 to 16 mm and proved to depend to a larger degree on particle size than on degree of compaction (Fig. 11). The correlation between effective particle size and penetration depth was, however, not strong (r 0.47), probably because particle shape and the amount of interlock vary widely. The data suggests minimal risk of too little cement penetration under any circumstances, but does probably have some implications for bone ingrowth. First, the minor dependence of penetration on degree of compaction suggests that any extra compaction to improve stability will only marginally affect bone ingrowth. Second, the stronger dependence of cement penetration on particle size suggests the main risk to bone ingrowth stems from inappropriate particle sizing. This ties in with Pratt et al.s nding that particles leaving small voids cause a reduction of bone ingrowth.

B.

Conclusion

Early stability of impaction-grafted implants depends to a large extend on the degree of graft compaction achieved. Morselized graft with larger particles and higher donor bone density requires less impaction effort to compact enough to carry the implant load. Producing larger bone particles will thus increase the likelihood of a stable implant. In addition, larger particles increase permeability of the compacted mass, facilitating cement penetration and formation of new bone.

ACKNOWLEDGEMENTS The authors thank Mr. Mike Haddaway, Mr. Ian May, Dr. Damien McLelland, Dr. John Merry, Mr. Bernd Netzer, and Dr. Andy Toms for their help during the experiments and all surgeons who performed the impaction grafting of the femoral stems. We also thank Johnson & Johnson (Leeds, UK) and Biomet (Swindon, UK) for their nancial support, and Johnson & Johnson, Biomet, and Howmedica (Staines, UK) for providing implants and instruments. Finally, we thank the Oswestry and Clwyd bone bank for donating some of the bone used in this study.

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REFERENCES
1. 2. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early subsidence following femoral impaction grafting. J Arthroplasty 1997; 12: 535 540. Franzen H, Toksvig-Larsen S, Lidgren L, Onnerfalt R. Early migration of femoral components revised with impacted cancellous allografts and cement. A preliminary report of ve patients. J Bone Joint Surg 1995; 77B: 862 864. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993; 75B: 14 21. Gokhale S, Dantas JP, Richardson JB, Soliman A, Cook F, Kuiper JH, Jones P. Variables affecting initial stability of impaction grafting for hip revision. Clin Orthop. In press Box GEP, Hunter WG, Hunter JS. Statistics for Experimenters: An Introduction to Design, Data Analysis, and Model Building. New York: Wiley; 1978. Schreurs BW, Slooff TJ, Buma P, Verdonschot N. Basic science of bone impaction grafting. Instr Course Lect 2001; 50: 211 220. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem in revisions of the hip using impaction allograft. Evaluation with radiostereometry and dual-energy x-ray absorptiometry. J Bone Joint Surg 1999; 81B: 135 142. Smith GN. Elements of Soil Mechanics. 6th ed. Oxford: Blackford Science; 1995. Tien NT. Dynamic and Static Behaviour of Driven Piles. Gothenburg: Chalmers University of Technology; 1987. Wilun Z, Starzewski K. Soil Mechanics in Foundation Engineering. 2nd ed. London: Surrey University Press: International Textbook Co.; 1975. Felluga B. GEMET, General European Multilingual Environmental Thesaurus. Copenhagen: EEA; 1999. http:/ /eionet.eu.int/GEMET Carter DR, Hayes WC. The compressive behavior of bone as a two-phase porous structure. J Bone Joint Surg 1977; 59A: 954 962. Verdonschot N, Huiskes R. Mechanical effects of stem cement interface characteristics in total hip replacement. Clin Orthop 1996; 329: 326 336. Smith EJ, Richardson JB, Learmonth ID, Evans G, Nelson K, Lee R, Dyson J. The initial stability of impaction grafting. Hip Int 1996; 6: 166 172. Ornstein E, Atroshi I, Franzen H, Johnsson R, Sandquist P, Sundberg M. Early complications after one hundred and forty-four consecutive hip revisions with impacted morselized allograft bone and cement. J Bone Joint Surg 2002; 84-A: 1323 1328. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Contained morselized allograft in revision total hip arthroplasty. Surgical technique. Orthop Clin North Am 1993; 24: 717 725. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction bone grafting in revision hip surgery. A high incidence of complications. J Bone Joint Surg 2000; 82B: 103 107.

3.

4.

5. 6. 7.

8. 9. 10. 11. 12. 13. 14. 15.

16.

17.

94 18.

Kuiper et al. Ornstein E, Franzen H, Johnsson R, Sundberg M. Radiostereometric analysis in hip revision surgeryoptimal time for index examination: 6 patients revised with impacted allografts and cement followed weekly for 6 weeks. Acta Orthop Scand 2000; 71: 360 364. Tagil M, Aspenberg P. Impaction of cancellous bone grafts impairs osteoconduction in titanium chambers. Clin Orthop 1998; 352: 231 238. Pratt JN, Griffon DJ, Dunlop DG, Smith N, Howie CR. Impaction grafting with morsellised allograft and tricalcium phosphate-hydroxyapatite: incorporation within ovine metaphyseal bone defects. Biomaterials 2002; 23: 3309 3317. Walker PS, Soudry M, Ewald FC, McVickar H. Control of cement penetration in total knee arthroplasty. Clin Orthop 1984; 155 164. Berzins A, Sumner DR, Wasielewski RC, Galante JO. Impacted particulate allograft for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of cement pressurization. J Arthroplasty 1996; 11: 500 506. Davies JP, Harris WH. In vitro and in vivo studies of pressurization of femoral cement in total hip arthroplasty. J Arthroplasty 1993; 8: 585 591.

19. 20.

21. 22.

23.

8
Preparation of the Femoral Head Prior to Milling: Does Inclusion of the Articular Cartilage Inuence Impaction?
An In Vitro Study with Human Femoral Heads
Ashit Bavadekar, Olivier Cornu, Bernard Godts, Christian Delloye, and Xavier Banse
Universite Catholique de Louvain Brussels, Belgium

John Van Tomme


Royal Military Academy Brussels, Belgium

I.

INTRODUCTION

The impaction bone grafting procedure has become an option in revision hip surgery and has been popularized by Slooff et al. [1] for the reconstruction of cavitary acetabular defects in revision hip arthroplasty. It was further modied by Gie et al. [2] for the femoral revisions. The procedure involves progressive impaction of morselized cancellous bone grafts in the femoral canal or the acetabular cavity, which are both decient in bone stock due to wear effects from a previous arthroplasty. A standard prosthesis is then cemented directly in contact with the impacted graft layer, which becomes a load-bearing material. The grafts can be remodeled and progressively transformed in normal living bone, restoring the patients bone stock. Achievement of correct implant stability is the technical goal of this procedure as well as a prerequisite for further remodeling of the grafts [3].
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Karrholm et al. [4] claim that hardness (or stiffness) of the impacted grafts is of primary importance to be able to sustain the cyclical loading forces of normal gait. The practice of impaction bone grafting has led the surgeons to assume that there is a relationship between impaction, compactness, and stiffness of the grafts. However, such a relationship is not substantiated by the literature. If it is obvious that impacting the grafts will aggregate the bone morsels, and repeated shocks could theoretically damage them and cause a reduction in their individual stiffness. Consequently, the rst goal of this study was to address the relationship between the number of impactions applied to the grafts layer and its resulting compactness and stiffness. The composition of the grafting material is another variable that may deeply affect the mechanical properties. The osteoarthritic femoral head harvested during hip replacement is the most common source of fresh frozen allografts for impaction bone grafting. It contains three different types of tissues: cancellous bone in its bulk, cortical bone (mainly from the neck), and remnants of articular cartilage or synovial lining. Regarding the tissues, our second goal was to address two questions: 1. 2. Is it really necessary to remove the residual articular tissues before the milling of the head? Can we leave and use the cortical bone from the femoral neck, or is it mandatory to use only cancellous bone?

II. A.

MATERIALS AND METHODS Preparation of Morselized Grafts

Twelve fresh frozen human femoral heads from 12 patients (4 females and 8 males) were procured at the time of primary hip arthroplasty for osteoarthritis and stored at 2808C. Each femoral head was subjected to plain radiography for a qualitative assessment to exclude evidence of severe osteopenia or important osteoarthritic cystic lesions. Two separate batches were made of 6 femoral heads each. The median age of the patients was 63 (58 73) years in batch 1 and 72 (51 83) years in batch 2. Each separate batch was processed to produce two types of graft, thus allowing a paired comparison. The femoral heads were cut into two halves in the coronal plane (anterior and a posterior half ), keeping the fovea femora capitis as the reference point, on a band saw. Half-femoral heads were weighed separately on a digital weighing scale (Mettler PE 3000, Zurich, Switzerland) before and after processing to estimate the loss of material. In the rst batch, one half of each head (alternatively the anterior or the posterior) was cleared of all adherent soft tissue, articular cartilage, and cortical

Femoral Head Preparation Table 1 Particle Data for 5 g Samples: Mean (min-max) Type of graft Batch 1 Cortico-cancellous with cartilage (n 17) Pure cancellous (n 18) Cortico-cancellous (n 18) Pure cancellous (n 18) No. of particles 222 (198 262) 252 (213 322) 210 (181 234) 270 (214 270) Mean particle size (mm2) 9.53 (7.37 11.08) 8.63 (6.78 10.50) 8.52 (7.20 9.65) 7.46 (6.11 8.99)

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bone from the neck to obtain pure cancellous grafts. The clearance was performed by holding the bone surface against the running blade of a band saw until cancellous tissue could be seen. This technique resulted in minimal bone loss. The other half of the same head was left intact. These half heads were used to prepare the cortico-cancellous grafts with articular cartilage. For the second batch, one half of each femoral head was processed to obtain pure cancellous samples, in a similar way to the rst batch. Preparation of the cortico-cancellous graft samples involved the retaining the cortical bone from the femoral neck, but removal of the articular cartilage and adherent soft tissue. In this experimental design, the pure cancellous bone in each batch bone was considered as the gold standard or the control and the other type of graft (cortico-cancellous with or without cartilage) as the test group. These half heads were milled separately twice for each type, as done in our surgical practice, with the small rasps of the Noviomagnus bone mill (Spierings, Nijmegen, Netherlands) (Table 1). The size of the morselized particles was 3.3+1 mm (mean+SD). For randomization of the samples, each type of morselized graft was mixed in a bowl and sampled in units of 5 g each. Eighteen samples of each type were selected randomly for mechanical testing.

B.

The Impaction Procedure

The impaction grafting was tested on a specially designed piece of apparatus (Fig. 1) that consisted of an aluminium tube (inner diameter 14.6 mm) to contain and conne the grafts. Thirty-six holes (1 mm diameter) facilitated the expulsion of the bone marrow during the course of an impaction. The tube was xed to a solid aluminium block. A solid cylindrical aluminium impactor (diameter 14.4 mm) telescoped freely in the cylinder. A 1 m iron rod was placed on top of the impactor. This served as a guide for a mass (simulating the classical impaction instrumentation) of 455 g.

98 Bavadekar et al. Figure 1 The grafts were impacted in a contained cavity with the vents for marrow expulsion during the course of an impaction. The design was based on the ancillary for impaction bone grafting, in which the weight travels over a xed distance (see text).

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The bone comprised 5 g samples of morselized graft thawed at room temperature 2 hours prior to the mechanical test. One sample at a time was loaded in the cylinder and tested. Information from preliminary tests indicated that, using this model, some changes could be expected for up to 150 impactions.

C.

Parameters

Three parameters were measured to describe the evolution of the material during impaction. Two of these, the height of the contained cylinder of morselized grafts and its elastic modulus, were measured at the rst, third, fth, and tenth impactions and thereafter in multiples of 10 up to the 150th impaction. The height was measured between two points (the top of the cylinder and the top of the impactor) with a digital calliper (Mitutoyo, Hiroshima, Japan) following the telescoping of the impactor into the tube. Elastic modulus (or stiffness) was measured by placing the testing device, without its guiding rod and mass, between the plates of a testing machine (Zwick Machine, Zwick GmbH & Co. Ulm, Germany). The upper plate of the machine gently compressed the impacting material at a speed of 0.5 mm/min. The load was measured by a 2 KN load cell and the displacement by an extensometer (Multisens, Zwick) positioned across the tube and the impactor. To avoid excessive compression of the grafts during elastic modulus measurement, the test was limited to a range of either 80 N of force (0.5 MPa) or 0.3 mm of displacement. The elastic modulus (in MPa) was calculated as the slope of the curve between 60 and 98% of maximal load (the linear part of the curve). After reaching the measurement limit, the cylinder of grafts was immediately unloaded. Knowing the time-dependent mechanical properties of morselized grafts (creep and recoil) [5], we chose to standardize the testing conditions for each sample. The height and elastic modulus measurement were performed over a constant time of one minute between impactions. The third parameter was the development of the apparent density of the impacted material. For the progession of density we stopped the procedure at different levels of impaction, gently expressed the impacted cylinders of graft in their original plastic tubes (diameter 15 mm), and rapidly froze the specimens. Consequently, out of the 18 samples in each group, 4 were impacted until the third impaction, 4 until the tenth impaction, 4 until the ftieth impaction, and 6 until the nal 150th impaction. To assess the density, the frozen graft samples were subjected to peripheral quantitative computerized tomographic scanning (XCT Research SA pQCT, Pforhzeim, Germany). Density measurements were taken from four different levels of the impacted graft cylinder (slice thickness 0.7 mm). These levels were selected by dividing the height of the cylinder into four equal parts. The density

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of a sample was calculated as the mean value of the four slices (g/cm3 of bone content) according to calibrations performed under the same conditions. D. Statistics

The differences in the evolution of the height and elastic modulus of the different grafts were analyzed using repeated measure ANOVA. The within-subject (sample) factor was the number of impactions, and the between-subject factor was the type of graft. Because the density was analyzed on different samples during the impaction, we compared the mean density of each type of graft at the four different levels of impaction considered with a paired t-test. These analyses were performed using SPSS 9.0 (SPSS Inc. Chicago, IL) separately for batch 1 and batch 2. Signicance level was xed at p , 0.05. III. A. RESULTS Material Weight Loss on Preparing Different Grafts

Preparing pure cancellous samples from a femoral head caused a mean loss of 36+6% of material in batch 1 and 40+7% in batch 2. In batch 2, removal of soft tissue and cartilage caused a loss of 25+2% of material weight (Table 2).

Figure 2 The diminution of the height due to progressive impaction for batches 1 and 2. Note that the number of impactions is presented as a log scale. The line represents the mean value and the bars the standard error of this mean value. Up to 3 impactions, n 18 (number of measurements performed); up to 10 impactions, n 14; up to 50 impactions, n 10; up to 150 impactions, n 6 for each type of graft.

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Figure 3 The evolution of the stiffness (Emod) of the material grafts with progressive impaction. The same amounts of data as in Figure 4 are used for mean and standard error of the mean (bars) calculations. In batch 1, note the difference in the modulus values reached between the pure cancellous and the cortico-cancellous with cartilage, while in batch 2 such a difference is not observed.

B.

Height

The height (Fig. 2) showed a steady decline corresponding to the log of the number of impactions. In batch 1, the ANOVA with repeated measures showed that height was higher for the cortico-cancellous with cartilage than for the pure cancellous bone (p 0.018). In batch 2 there was a slight but non-signicant difference, with a faster impaction for the cortico-cancellous without cartilage when compared to pure cancellous grafts ( p 0.06).

C.

Elastic Modulus

The grafts were rendered progressively stiffer until the 30th impaction (Fig. 3). In batch 1, rise in the elastic modulus was signicantly higher for the pure cancellous (p , 0.001) than for the cortico-cancellous with cartilage. The mean nal modulus of the pure cancellous impacted grafts was about 48.4 MPa while it was 26.3 MPa for cortico-cancellous grafts with articular cartilage. Furthermore, the cortico-cancellous with cartilage reached the same value of elastic modulus after 150 impactions as compared to the pure cancellous after 5 impactions .

102

Table 2 Whole head Fresh frozen (FF) half head

Origin of Material and Weight Loss on Preparation of Morselized Grafts Freeze-dried (FD) half head

Donor

Name Post. Post. Post. Ant. Ant. Ant.

Sex

Age (yr)

Weight (g)

Weight without cartilage (g) Ant./Post. half Weight (g) Ant./Post. half Ant. Ant. Ant. Post. Post. Post.

Weight (g)

Treated weight (g)

Freezedried weight (g)

VP PC WM DG LC TJ

M F F M M M

Mean:

75 61 72 53 72 72 67.5

90.9 86.0 79.6 100.9 94.4 87.2 89.8

73.8 67.0 66.2 66.8 71.4 66.7 68.7

37.1 35.2 32.6 31.4 39.0 32.4 34.6

35.0 29.8 31.8 33.6 35.1 32.5 33.0

18.5 15.4 13.7 22.8 15.2 18.7 17.4

12.5 11.3 9.4 13.5 10.2 12.6 11.6 Bavadekar et al.

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In batch 2, rise in the elastic modulus was similar for the pure cancellous and the cortico-cancellous without cartilage (p 0.62). Mean nal elastic modulus was, respectively, 41.7 and 41.9 MPa, cortico-cancellous having a similar value to that of the pure cancellous impacted grafts. D. Mean Density

The mean density increased in proportion to further impaction (Fig. 4). In batch 1 the pure cancellous grafts showed higher density values than the corticocancellous with cartilage after 10 (p 0.013), 50 (p 0.045), and 150 impactions (p , 0.001). Mean density of the impacted cylinders in batch 2 showed signicant differences between the pure cancellous and cortico-cancellous grafts after 50 (p 0.032) and 150 impactions (p 0.001). Cortico-cancellous grafts reached a slightly higher density than pure cancellous controls.

IV.

DISCUSSION

Morselized grafts were obtained from human femoral heads that were harvested during primary hip arthroplasties. The femoral heads were neither treated nor defatted [6] to perform the tests with all their normal constituents, especially the

Figure 4 The increase in density (g/cm3) in batches 1 and 2 on successive impactions. At 3, 10, and 50 impactions, density measurements were carried out on four samples of each type of graft. At 150 impactions, six measurements were done. Note the signicant difference in the rise in densities between impactions 50 and 150.

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marrow. In preparing the material for batches 1 and 2, the goal was to get two groups of samples as homogeneous as possible and prepared from the same six femoral heads. To rule out local discrepencies of bone quality due to different trabecular patterns [7], the femoral heads were divided in the coronal plane in two halves. Mixing the morselized grafts reduced the variability between the samples that would be linked to the quality of each individual head [8]. Therefore, the only difference between the groups could be linked to the presence or absence of some constituent of the original femoral head (cartilage or cortical bone from the neck). The experimental impaction procedure was standardized in keeping many parameters constant (e.g., time between every round of impactions and the persons performing them). Grafts were impacted by intermittent blows in rounds of 10 and were not continuously compressed to t the clinical impaction procedure [5,8]. The drop in mass was highly reproducible, but did not exactly mimic the clinical situation. The characteristics of the shock wave are certainly not the same as those found during an actual surgical procedure. Expulsion of the marrow though small holes in the tube might not be as complete and easily performed in the bleeding diaphysis. Keeping these caveats in mind, it must be clear that the number of impactions presented in this study do not correspond to the number of impactions that the surgeon would have to perform. The experimental set-up simulated the impaction procedure but not the progressive prosthetic migration observed in clinical practice (subsidence). This implant migration is a process going on over thousands of physiological loading cycles, while we tested the effect of a few blows on the morselized grafts. Studies have been carried out on the mechanical behavior of morselized grafts considered as a material. Brewster et al. [6] investigated the shear modulus of impacted grafts, showing, in a small number of samples, that there was a relationship between shear strength and energy of impaction. Brodt et al. [8] performed triaxial compression tests on unimpacted but slightly compressed morsels. Giesen et al. [9] and Ullmark and Nilsson [5] worked on the timedependant properties (creep and recoil) of impacted material. Effective impactions on the graft layer caused stiffening of the grafts in a more or less tightly packed homogeneous layer from a loose particulate state towards a well-impacted state. Compactness and compressive stiffness of the graft layer were monitored to obtain insight into the evolution of the material during the impaction process. The values of the elastic modulus may not be precise but do give the reader an idea of the relative stiffness these grafts would reach on receiving effective impaction blows. Morselized grafts become consistently more deformed, compact, and dense during the impaction. The decrease in height (a relative measure of compactness) is due to the deformation of the grafts and expulsion of the

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marrow and fat globules through the vents in the testing tube. The evolution of the height or density further t a decimal log (log 10) of the number of impactions (Figs. 2, 4). This suggests that the reduction in height was almost the same during the rst 10 impactions as from the 10th to the 100th impaction. For the modulus such a relationship did not hold true. Beyond the 30th impaction, the modulus stabilized and reached a plateau (Fig. 3). We observed a limit of impaction beyond which, on further impactions, there was no further rise of the elastic modulus. During that phase the aggregated particles were probably accumulating damage. Structurally damaged cancellous bone is known to present a dramatically reduced elastic modulus [10]. However, on impacting the graft layer, such damage would be offset by the ongoing slow rise in compactness of the morselized grafts. On the other hand, in our experiment there was no drop in the modulus of the grafts, so we have no experimental data to suggest that overimpaction is dangerous for the mechanical integrity of the graft layer and hence for the initial implant stability. The general relationship between number of impactions and stiffness demonstrates that the quality of the impaction itself is of primary importance to obtain a sufciently stiff layer of grafts and a stable implant. The data presented here were also aimed at giving the surgeon some experimental indications about the best way to prepare femoral heads before milling. We estimated that the minimal loss of material in preparing a femoral head for obtaining pure cancellous bone is 40% of the initial graft mass. In comparison, the minimal loss related to the removal of soft tissues and retaining the neck is 25%. This loss is mainly due to bone debris produced by the saw, and the mass of cartilage on an osteoarthritic head probably represents less than 10% of the cortico-cancellous morselized grafts with cartilage. Comparing the loss in batches 1 and 2, it can also be calculated that the cortical neck represents 15% of the mass of the allograft. Although Slooff et al. [11] report the use of cancellous graft alone, Gie et al. and other teams in United Kingdom morselize the whole femoral head [6,12]. This terminology is somewhat confusing, but there are no reports specically stating that cartilage remnants were retained while milling the heads. The presence of cartilage prevents efcient impaction of the morselized grafts, probably due to its elastic nature. At any level of impaction, the measured elastic modulus of the graft layer with the cartilage was always about the half of its pure cancellous control group. The presence of cartilage particles delayed effective impaction and prevented the grafts from reaching a relatively high density (Fig. 4) and a high modulus (Fig. 3). This conrms that cartilage must be removed before milling. The cortico-cancellous grafts without the articular cartilage had stiffness values as good as their control group (Fig. 3). They reached slightly higher values

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of compactness and density (probably due to cortical struts) (Figs. 2, 4) when compared to their purely cancellous control. It seems unlikely that a few cortical bone fragments will signicantly alter the biological response of the graft. However, our experiment did not address the biological aspect of the impaction bone grafting technique, and further clinical follow-up studies or in vivo animal studies should address this question. Leaving the cortical bone from the neck did not interfere with the compaction of the morselized grafts or the creation of a stiff layer of bone. In these days of imbalance between supply and demand of allografts [13], saving 15% of material would be in the interest of bone banks worldwide.

ACKNOWLEDGMENTS The authors would like to extend their gratitude to Aime Decoster for his constant and skillful support in the mechanical testing.

REFERENCES
1. 2. Slooff TJ, Huiskes R, van-Horn J, Lemmens AJ. Bone grafting in total hip replacement for acetabular protrusion. Acta Orthop Scand 1984; 55:593 596. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg Br 1993; 75:14 21. Ling RS. Femoral component revision using impacted morsellised cancellous graft (letter; comment). J Bone Joint Surg Br 1997; 79:874 875. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem in revisions of the hip using impaction allograft. Evaluation with radiostereometry and dual-energy x-ray absorptiometry. J Bone Joint Surg Br 1999; 81:135 142. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength. J Arthroplasty 1999; 14:1019 1023. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR. Mechanical considerations in impaction bone grafting. J Bone Joint Surg Br 1999; 81:118 124. Brown TD, Ferguson ABJ. Mechanical property distributions in the cancellous bone of the human proximal femur. Acta Orthop Scand 1980; 51:429 437. Brodt MD, Swan CC, Brown TD. Mechanical behavior of human morselized cancellous bone in triaxial compression testing. J Orthop Res 1998; 16:43 49. Giesen EB, Lamerigts NM, Verdonschot N, Buma P, Schreurs BW, Huiskes R. Mechanical characteristics of impacted morsellised bone grafts used in revision of total hip arthroplasty. J Bone Joint Surg Br 1999; 81:1052 1057.

3. 4.

5. 6.

7. 8. 9.

Femoral Head Preparation 10. 11.

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12.

13.

Keaveny TM, Wachtel EF, Guo XE, Hayes WC. Mechanical behavior of damaged trabecular bone. J Biomech 1994; 27:1309 1318. Slooff TJ, Buma P, Schreurs BW, Schimmel JW, Huiskes R, Gardeniers J. Acetabular and femoral reconstruction with impacted graft and cement. Clin Orthop 1996; 324:108 115. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Contained morselized allograft in revision total hip arthroplasty. Surgical technique. Orthop Clin North Am 1993; 24:717 725. Galea G, Kopman D, Graham BJ. Supply and demand of bone allograft for revision hip surgery in Scotland. J Bone Joint Surg Br 1998; 80:595 599.

9
Impaction Bone Grafting with Processed Freeze-Dried Allografts
Evolution of the Compactness and Stiffness During Impaction
Olivier Cornu, Ashit Bavadekar, Bernard Godts, Christian Delloye, and Xavier Banse
Universite Catholique de Louvain Brussels, Belgium

John Van Tomme


Royal Military Academy Brussels, Belgium

I.

INTRODUCTION

Impaction bone grafting is become an accepted procedure for managing revision arthroplasties with bone defects. Most papers have reported good implant stability and pain relief [1 4]. The aim of the procedure is to pack bone densely into the cavity in which a new prosthesis will be implanted. One of the key factors inuencing outcome is the stiffness of the impacted material [2,5]. Usually the impaction bone grafting is performed with fresh-frozen femoral heads. The use of this grafting material has the potential for disease transmission [6], which is further increased when the grafts come from multiple donors. A hip revision with impaction bone grafting usually requires two to three femoral heads [7,8], and most bone banks currently face a limited supply of fresh-frozen femoral heads [9]. Processed freeze-dried bone allograft has been used for selected indications in orthopedics and is now a long tested material [10 12]. Nowadays, preparation of these grafts includes removal of marrow and bone cell, treatment with solventdetergent, prion inactivation treatment, freeze-drying, and nally gamma
109

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irradiation. These steps all have a cumulative effect in reducing the risk of disease transmission, producing very safe human grafting material. Due to the alteration of the mechanical properties of bone by freeze-drying, mostly because of nal gamma irradiation [13,14], it has been used rather cautiously in clinical practice. Irradiated freeze-dried bone is known to be less strong, less stiff, and signicantly more brittle than the fresh-frozen control when tested in static compression [15]. Because of this, Duncan et al. have questioned the suitability of freeze-dried graft in impaction bone grafting [1]. It would be interesting to know if the altered mechanical properties of freeze-dried grafts affect their ability to create a morselized bony layer of adequate stiffness. To the authors knowledge, there has been neither a documented study of use of freeze-dried, irradiated morselized grafts in impaction bone grafting nor any study concerning their mechanical properties. The goal of this study was to investigate, in vitro, the development of the density and stiffness of processed freeze-dried cancellous bone during impaction grafting and explore its mechanical suitability for this procedure.

II. A.

MATERIALS AND METHODS Donor Selection and Source of Grafts

Six fresh-frozen human femoral heads from six patients (two females and four males) were procured at the time of primary hip arthroplasty for osteoarthritis and stored at 2808C. The median age of the donors was 72 (53 75) years. Each femoral head was weighed separately (Table 1) and radiographed to exclude severe osteopenia or osteoarthritic lesions. B. Graft Processing

In a previous study [16] it was shown that retaining the articular cartilage in the preparation of the morselized grafts had a deleterious effect on the mechanical outcome during impaction, while inclusion of the cortical bone from the neck had no effect except to increase the amount of material. Consequently, the femoral heads were cleared of all their soft tissues (articular cartilage remnants and synovium), while the cortical neck was retained. The heads were then cut with a bandsaw into two halves in the coronal plane, keeping the fovea femora capitis as the reference point. Half femoral heads were weighed separately on a digital weighing scale (Mettler PE 3000, Zurich, Switzerland) (Table 1). Two groups consisting of six half femoral heads were made, with the anterior or posterior half of the same head being alternatively included in one of the batches. The half heads of the fresh frozen group were stored frozen at 2808C (Forma Scientic Inc., Marietta, Ohio). The other halves underwent the following

Processed Freeze-Dried Allografts

111

Table 1 Origin of the Material and Weight Loss on Preparation of the Morsellized Grafts Fresh frozen (FF) half head

Donor

Whole head

Freeze Dried (FD) half head

FreezeWeight Treated dried Ant/ without Ant/ Weight cartilage Post Weight Post Weight weight weight (g) (g) half (g) half (g) (g) Name Sex Age (g) VP PC WM DG LC TJ Mean: M F F M M M 75 61 72 53 72 72 67.5 90.9 86.0 79.6 100.9 94.4 87.2 89.8 73.8 67.0 66.2 66.8 71.4 66.7 Post Post Post Ant Ant Ant 68.7 37.1 35.2 32.6 31.4 39.0 32.4 Ant Ant Ant Post Post Post 34.6 35.0 29.8 31.8 33.6 35.1 32.5 33.0 18.5 15.4 13.7 22.8 15.2 18.7 17.4 12.5 11.3 9.4 13.5 10.2 12.6 11.6

processing. They were thoroughly washed under a jet of deionized water to remove bone marrow and blood cells. Lipids were extracted by a 1: 1 (v/v) chloroform-methanol solution renewed 3 times for at least 2 days and rinsed with methanol and water [11]. Denaturation of the bone proteins (prion-inactivating procedure) was then applied and followed once again by a 1-day rinsing in tap demineralized water. At the end of this chemical treatment, the half heads were gently centrifugated to eliminate the water and weighed to measure the loss due to removal of some bone constituents. Half heads from both groups were then morselized twice, when wet, with the small rasps of the Noviomagnus bone mill (Spierings, Nijmegen, Netherlands). The morselized grafts from the processed group were placed in open vials separately, freeze-dried for 48 72 hours (temperature condensor 2808C, temperature of the chamber 2308C, working vacuum 11024 mmHg) and irradiated at a minimal irradiation dose of 25 kGy source of irradiation Cobalt 60 [15]. After freeze-drying and irradiation, the residual moisture of the bone was calculated by gravimetry to be 2.5% of dry material (Sartorius MA 30, Goettingen, Germany).

C.

Sampling and Randomization of Samples

The fresh-frozen morselized grafts were mixed in a bowl and separated into 5 g samples. The processed morsels were also mixed to homogenize the whole

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Figure 1 Typical appearance of the two types of morselized grafts. Note that 5 g of fresh frozen morselized grafts corresponds to 1.75 g of freeze-dried. Their apparent volume remains the same.

batch and sampled in units of 1.75 g (Fig. 1). The 5 g/1.75 g ratio was determined according to our measurements of weight loss during the processing (see Table 1), and equivalent amount of bone material was present in both types of sample. Eighteen randomly selected samples of the two types of graft were chosen for the mechanical testing. The experiment was designed so that the freshfrozen bone was the control and the processed bone the test group. D. Impaction on the Grafts

The bone was impacted into a specially designed apparatus consisting of an aluminum tube (inner diameter 14.6 mm) to contain and conne the grafts. Thirty-six holes (1 mm diameter) were made in it to facilitate the expulsion of the bone marrow during the course of an impaction. The tube was xed to a solid aluminum block. A solid cylindrical aluminum impactor (diameter 14.4 mm) telescoped freely in the cylinder. A 1 m iron rod was placed on top of the impactor and served as a guide for a mass (simulating the classical impaction instrumentation) of 455 g. One fall of the mass on the impactor was considered as one impaction [16]. The fresh-frozen morselized grafts were thawed at room temperature 2 hours prior to the mechanical test. The freeze-dried samples were separately

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rehydrated with saline for 30 minutes [15] before being tested. One sample at a time was loaded in the cylinder and tested. The impaction procedure was interrupted regularly (at 1, 3, 5, 10, 20, and every 10 impactions up to 150) to measure the height of the column of morselized grafts and its stiffness. The height was measured with a digital caliper as the distance between the top of the tube and a xed point on the impactor. The compressive stiffness (or Emod, MPa) of the impacted grafts was measured by placing the experimental setting in a testing machine (Zwick model Z50/TH3A, Zwick GmbH, Ulm, Germany). The upper plate of the machine compressed gently the impacting material at a speed of 0.5 mm/min. The load was measured by a 2 KN load cell and the displacement by an extensometer (Multisens, Zwick) positioned across the tube and the impactor (Fig. 2). To avoid excessive compression of the grafts during the measurement, the test was limited to a range of either 80 N of force (0.5 MPa) or 0.3 mm of displacement. Stiffness was calculated as the slope of the curve between 60 and 98% of maximal load (the linear part of the curve).

Figure 2 The experimental setting: the aluminum cylinder containing the grafts placed between the plates of the testing machine for determination of the stiffness of the impacted grafts. The same setting was used with a guiding rod and a gliding mass to impact the samples before stiffness measurement.

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After reaching the measurement limit, the cylinder of grafts was immediately unloaded. Knowing the time-dependent mechanical properties of morselized grafts (creep and recoil, [17]), we chose to standardize the testing conditions for each sample. The height and stiffness measurements were performed over a constant time of one minute between impactions. The third variable was the development the density of the impacted material. To monitor the densitometric changes, the procedure was interrupted at different levels of impaction. The impacted cylinders were gently expressed from the aluminum cylinder, placed in plastic tubes, and immediately frozen on dry ice. Consequently, out of the 18 samples of each group, 4 were impacted until the third impaction, 4 until the tenth, 4 until the ftieth, and 6 until the nal 150th. The frozen impacted specimens were scanned using a pQCT (peripheral quantitative computed tomography machine, model XCT Research SAw, Stratec, Pforzheim, Germany). Density value is expressed in g/cm3. E. Statistical Analysis

Statistical analysis was performed using the ANOVA with repeated measures for studying the differences in the mechanical parameters (height and stiffness) between the graft types (SPSS 9.0, SPSS Inc., Chicago, IL). This analysis was performed considering results from one to 3, one to 10, one to 50, and one to 150 impactions to investigate the initial part of the impaction procedure. As the density was measured on different samples during the impaction, the mean density obtained with both type of grafts was compared using a paired t-test. This test was repeated for the four different levels of impaction.

III. A.

RESULTS Weight Loss

Removal of the cartilage from a femoral head caused, in weight, a loss of 24% of material. During the processing, the removal of the bone marrow, fat, and cellular debris with water jet and the chemical treatment yielded a drop of 47% of the weight. After freeze-drying, the weight of these chemically treated bone samples further dropped to 35% of their initial weight (Table 1). B. Height

The density or the decrease in height of the column of grafts (deformation on impaction) showed a considerable difference between the two types of grafts (Fig. 3). Freeze-dried graft layer deformed to about one third of its initial height, while the fresh-frozen control reached half of its initial height. Both the rate of

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Figure 3 The evolution of the height during impaction for the two types of grafts. Note that the number of impactions is presented as a log scale. The line represents the mean value and the bars the standard error of this mean value. Up to three impactions, n 18 (number of measurements performed); up to 10 impactions, n 14; up to 50 impactions, n 10; up to 150 impactions, n 6 for each type of graft.

deformity after up to 3, 10, or 50 impactions and the nal height after up to 150 impactions was lower for the freeze-dried bone ( p , 0.001 ANOVA). C. Stiffness

The pattern of increase in the stiffness of the two types of grafts showed the following similarities and differences (Fig. 4). Both the freeze-dried and the fresh-frozen grafts reached a nal mean modulus of about 55 MPa after 150 impactions. The freeze-dried bone achieved this after only 20 impactions. In contrast, the fresh-frozen morselized bone showed a slow but constant increase of the modulus levels after successive impactions. After the 70 impactions, the value was the same as for the freeze-dried bone. The ANOVA with repeated trials showed that the stiffness increased signicantly faster up to 3 ( p , 0.001), 10 ( p , 0.001), and 50 ( p 0.005) impactions but no more when considering the whole curve until 150. This emphasizes that the difference between the two curves is noted only in the initial stages of the experimental impaction procedure (Fig. 4). D. Density

In both groups the density increased during impactions (Fig. 5). The mean density of fresh-frozen morselized graft rose from a value of 0.45 g/cm3 at 3 impactions

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Figure 4 The evolution of the stiffness (stiffness) of the two types of grafts with progressive impaction. Same amounts of data as in Figure 3 are used for mean and standard error of the mean (bars) calculations. Note the difference in the trends of the curves, which reach more or less the same nal modulus. This implies that the freeze-dried morselized grafts are impacted faster as compared to the fresh frozen, which steadily becomes stiffer, but never reaches a plateau in its values. ANOVA indicated signicantly higher modulus up to three impactions (p , 0.001, ), up to 10 impactions (p , 0.001, ), and up to 50 impactions (p 0.005, ), but not up to 150 impactions (p . 0.05, NS).

to 0.65 g/cm3 at 150 impactions. In contrast, the freeze-dried morselized grafts showed a rapid rise in density from 0.5 g/cm3 at 3 impactions to nal value of 0.95 g/cm3 at 150 impactions. At 3, 10, 50, and 150 impactions the density was signicantly higher for the freeze-dried bone ( p 0.005, p , 0.001, p , 0.001, and p , 0.001, respectively).

IV.

DISCUSSION

For obtaining unbiased comparison of two types of morselized allografts, the pairing of samples is a critical aspect of the experimental design. In this study, the osteoarthritic femoral heads were split in two halves, and each half was accorded to one group. This allowed us to obtain two groups of grafts coming from the same set of femoral heads. After processing and milling, the morselized grafts from each group were mixed to increase the homogeneity of the samples within that group and reduce the between-sample variability. In the freeze-dried group

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Figure 5 The evolution of density (g/cm3) for the two types of graft on successive impactions. At 3, 10, and 50 impactions, density measurements were carried out on four samples of each type of graft. At 150 impactions, six measurements were done.

the weight of material for one sample was adjusted to account for loss of marrow, fat, and water during the processing. Therefore, the same amount of bone matter was poured in the cylinder. Although it not shown on the log chart (Fig. 3), the mean height before impaction was the same for both groups (26 mm). All of these experimental details standardized the comparison between the fresh-frozen and the processed morselized bone grafts. The encouraging mechanical properties of processed freeze-dried bone in impaction bone grafting may seem inconsistent with the results of static compressive tests previously performed in our laboratory [15]. As in the present study, these tests were done after 30 minutes of rehydration on similarly treated cancellous bone from femoral heads. The treatment induced a 42% reduction of the strength, a 21% reduction in modulus, and 75% reduction in work to failure (embrittlement of the bone). However, the mechanics of impaction morselized grafting is completely different from static testing. This study conrmed that stiffness of the graft layer was most dependent on the bone density achieved by successive impactions [16]. Our model clearly shows that the processed bone became impacted much faster than the fresh-frozen control (Fig. 4). This may be caused by different factors. First, on impacting the grafts, the stress is applied at high speed on the material. In such conditions, bone marrow may play an important role [18], and hence, the replacement of bone marrow by saline in the

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processed bone may accelerate the compaction of the grafts [2]. Second, the embrittlement due to bone processing [15] may be helpful in impaction bone grafting. The higher the brittleness, the faster the compaction, and even if the morsels of graft has a 21% lower modulus [15], a faster rise in bone density leads to a faster rise in stiffness (Fig. 5). Although the main advantage of the processed bone is the striking reduction of the risk of disease transmission because of multiple treatments, it could also improve surgical practice. In practice, three to ve times fewer hammer blows are required to impact the processed bone correctly and get an equivalent modulus to fresh-frozen bone. In the operating room, this may spare surgical time and reduce the risks of fracture of the femoral cortex, which remain one of the complications of the impaction procedure [3,4,19]. Dispensed as ready to use and stored packed at room temperatures, the morselized freeze-dried grafts could have further clinical implications in saving the surgical time lost morselizing fresh-frozen femoral heads. Finally, as there is no quarantine period for the processed freeze-dried grafts [20], such grafts could be made more readily available than fresh-frozen femoral heads. On the other hand, the use of processed bone may also be disadvantageous. As shown by the height and density data, if the surgeon impacts the processed grafts as much as the fresh-frozen ones, the amount of bone needed to ll a given cavity will be 70% higher, but with the benet of a more stable reconstruction. It can be concluded that, contrary to what was expected, the present model of impaction failed to show that processed freeze-dried was mechanically inferior to the fresh-frozen material. Because it can be impacted faster, it could be mechanically more efcient than the fresh-frozen bone in surgical conditions. The highest safety standards do not necessarily impair implant stability.

ACKNOWLEDGMENTS The authors would like to extend their gratitude to Prof. J. P. Devogelaer for obtaining density data.

REFERENCES
1. 2. Duncan CP, Masterson EL, Masri BA. Impaction allografting with cement for the management of femoral bone loss. Orthop Clin North Am 1998; 29:297 305. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem in revisions of the hip using impaction allograft. Evaluation with radiostereometry and dual-energy x-ray absorptiometry. J Bone Joint Surg 1999; 81:135 142.

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5. 6. 7. 8. 9. 10.

11. 12. 13. 14. 15.

16.

17. 18. 19.

20.

Leopold SS, Jacobs JJ, Rosenberg AG. Cancellous allograft in revision total hip arthroplasty. A clinical review. Clin Orthop 2000; 371:86 97. Slooff TJ, Buma P, Schreurs BW, Schimmel JW, Huiskes R, Gardeniers J. Acetabular and femoral reconstruction with impacted graft and cement. Clin Orthop 1996; 324:108 115. Ling RS. Femoral component revision using impacted morsellised cancellous graft (letter; comment). J Bone Joint Surg 1997; 79(B):874 875. Tomford WW. Transmission of disease through transplantation of musculoskeletal allografts. J Bone Joint Surg 1995; 77(A):1742 1754. Galea G, Kopman D, Graham BJ. Supply and demand of bone allograft for revision hip surgery in Scotland. J Bone Joint Surg 1998; 80(B):595 599. Henman P, Finlayson D. Ordering allograft by weight: suggestions for the efcient use of frozen bone-graft for impaction grafting. J Arthroplasty 2000; 15:368 371. Norman-Taylor FH, Villar RN. Bone allograft: a cause for concern? (editorial). J Bone Joint Surg 1997; 79(B):178 180. Cornu O, de Halleux J, Banse X, Delloye C. Tibial tubercle elevation with bone grafts. A comparative study of autograft and allograft. Arch Orthop Trauma Surg 1995; 114:324 329. Delloye C, Allington N, Munting E, Vincent A. Lyophilized banked bone. Technique and results after 3 years of use. Acta Orthop Belg 1987; 53:2 11. Fabry G. Allograft versus autograft bone in idiopathic scoliosis surgery: a multivariate statistical analysis. J Pediatr Orthop 1991; 11:465 468. Anderson MJ, Keyak JH, Skinner HB. Compressive mechanical properties of human cancellous bone after gamma irradiation. J Bone Joint Surg 1992; 74(A):747 752. Pelker RR, Friedlaender GE, Markham TC. Biomechanical properties of bone allografts. Clin Orthop 1983; 174:54 57. Cornu O, Banse X, Docquier PL, Luyckx S, Delloye C. Effect of freeze-drying and gamma irradiation on the mechanical properties of human cancellous bone. J Orthop Res 2000; 18:426 431. Bavadekar A, Cornu O, Godts B, Delloye C, Van Tomme J, Banse X. Stiffness and compactness of morsellised grafts during impaction: an in vitro study with human femoral heads. Acta Orthop Scand 2001; 72(5):470 476. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength. J Arthroplasty 1999; 14:1019 1023. Carter DR, Hayes WC. The compressive behavior of bone as a two-phase porous structure. J Bone Joint Surg Am 1977; 59:954 962. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction bone rafting in revision hip surgery. A high incidence of complications. J Bone Joint Surg 2000; 82(B):103 107. European Association of Musculo Skeletal Transplantation (EAMST) and European Association of Tissue Banks (EATB). Common Standards for Musculoskeletal Tissue Banking. Vienna, 1997.

10
Bone Graft Substitutes for Impaction Grafting
Ashley W. Blom and Ian D. Learmonth
University of Bristol, Bristol Royal Inrmary Bristol, England

Total hip arthroplasty is one of the most successful surgical procedures of the last century. Periprosthetic osteolysis and aseptic loosening is the most common cause of failure. The incidence of revision surgery has increased with the increasing number of primary hip arthroplasties performed annually worldwide. Loss of bone stock is the major challenge at revision hip arthroplasty. This has been addressed, with good medium-term results, by morselized impaction allografting [1]. However, there are now concerns over availability [2 4], infection [5 7], and cost [8]. An aging population will result in an increase in the number of primary total hip replacements. Galea has warned of the impending shortage of donor femoral heads and said: This source cannot meet the demand for revision surgery of the hip or for other operations because of the increase in the number of revisions and the use of techniques which require more bone, such as impaction grafting, which may use up to ve femoral heads. Other studies reached similar conclusions [2 4,9]. Allografts have the potential to invoke rejection by activating T-cell mediated immune responses from the host [10]. Friedlander et al. have identied donor-specic anti-HLA antibodies in human recipients of freeze-dried allografts [11]. Sensitization does not seem to adversely inuence clinical outcome [12]. Viral, bacterial, and prion infections remain a potential problem with bone grafting despite all the meticulous standard preventative measures. Hepatitis C and human immunodeciency virus (HIV) are of particular concern, the latter
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more so because of the problem with effective screening consequent upon the highly variable window between infection with HIV and the presence of detectable antibodies [5,13,14]. The incidence of postoperative infection is twice as high with allograft bone as compared with autograft bone [7] and is inuenced by a number of variables. Burgeoning health care costs make cost containment an important consideration. Meding et al. outlined the costs of the disposables used at impaction grafting and noted that femoral heads cost $950 each, with up to ve being used at a time [8]. The issues of availability, antigenicity, infection, and expense can all be addressed by the introduction of a less costly but equally effective bone substitute. An ideal bone graft substitute needs to impart structural stability under load in order to permit early weight bearing of the patient. It also needs to maintain this stability over time while subjected to the biological processes and responses of the body. Ideally the bone graft substitute should itself in time be replaced by living host bone, thereby restituting bone stock loss. This would be particularly helpful in younger patients, who would be expected to require further revision surgery. The ideal bone substitute should: 1. 2. 3. 4. 5. 6. Impart structural stability Encourage neo-ossication by means of osseoconduction, substitution, and osseoinduction Be inexpensive Have unlimited availability Have no infectivity Provoke no antigenicity

Bone grafts and bone graft substitutes can be broadly classied as shown in Table 1. More than 50 types of bone graft substitutes are now on the market, all attempting to address the above problems (Table 2).

I.

XENOGRAFT

Bovine bone has been investigated as a potential substitute for human allograft bone since the 1960s [15]. More recently Levai and Boigard reported good results in 27 out of 30 cases using bovine bone in acetabular reconstruction in total hip revision [16]. Bovine bone is biocompatible for human osteoblasts [17]. Hubble et al. showed that when cyclically loaded, bovine bone exhibited stability similar to human bone when used as a morselized graft in impaction grafting of the femur. Their pilot studies in sheep showed graft incorporation with new bone formation comparable with allograft [18].

Bone Graft Substitutes for Impaction Grafting Table 1 Biological human Autograft Classication of Bone Graft Substitutes Biological nonhuman Xenograft Synthetic nonabsorbable Methylmethacrylate Synthetic absorbable Calcium sulfate

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Biological/ synthetic combinations Collagen matrix (ceramic/ brillar collagen)

Allograft

Corraline

Glass-ionomers

Ceramic: Hydroxyapatite Tricalcium phosphate Polyhydroxy acids

Other (e.g., bamboo [103,104], and eggshell [105])

Other studies have highlighted problems with bovine xenograft. Begley et al. demonstrated that bovine xenograft causes intense inammatory reactions that are not provoked by coral when used in identical circumstances [19]. There are also fears with regard to prion infection and patient acceptability in view of recent scares caused by bovine spongioform encephalopathy (BSE). II. POLYMETHYLMETHACRYLATE (BONE CEMENT)

This is a nonabsorbable material widely used to x prostheses in joint replacement surgery. It is a lling material and not a glue. Although it has been used as a bone graft substitute in tumour surgery [20], it has many limitations, including low tensile strength, brittleness, and a tendency to provoke an aggressive osteolytic response [21]. When used to replace lost bone stock in revision total hip arthroplasty, the results have invariably been poor [22 25]. Its application as a bone graft substitute is therefore limited. III. CALCIUM SULFATE (PLASTER OF PARIS)

Calcium sulfate was used as long ago as 1892 by Dreesman to ll bony defects caused by tuberculous osteomyelitis [26]. Since then it has fallen into disfavor as it is quickly absorbed (within 4 8 weeks) and thus provides poor structural

124 Table 2 Commercially Available Allograft Substitutes

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Allograft substitute Bovine xenograft

Commercial products and sources Bio-Oss (Osteohealth, Shirley, NY) Unilab (Barrie, Ontario, Canada) Pyrost (Stryker Howmedica, Rutherford, NJ) Luboc (Ost Developpement, France) Biocoral (INOTEB, Saint Gonnery, France) ProOsteon (Interpore Cross Int., Irvine, CA) Interpore 200 (Interpore Cross Int., Irvine, CA) HTR-PMI (Lorenz, Jacksonville, FL) Ionogran (Ionos Medizinische Produkte, Germany) Bioglass (US Biomaterials, Alachua, FL) BioGran (Orthovita, Malvern, PA) Hapset (Lifecore Biomedical, Chasla, MN) Biosorb (Aesculap, Lourdes, France) Norian SRS (Synthes-Stratel, Cupurtino, CA) BoneSource (Stryker Howmedica, Rutherford, NJ) Alpha BSM (ETEX Corp., Cambridge, MA) Osteogen (Impladent, Holliswood, NY) Cerapatite (Ceraver Osteal, Roissy, France) Synatite (Aesculap, Lourdes, France) Cementek (Teknimed, Vic-en-Bigorre, France) Triosite (Zimmer, Cedex, France) porous Apacoram (Asahi Optical, Tokyo, Japan) porous Calcitite (Calcitek International, Carlsbad, CA) Ostilit (Stryker Howmedica, Rutherford, NJ) porous Collagraft (Zimmer, Cedex, France) Callopat (Osteo AG, Switzerland) Grafton (Osteotech, Eatontown, NJ) Ne-Osteo (Stryker Howmedica, Rutherford, NJ)

Coralline hydroxyapatite

PMMA Glass ionomer

Calcium sulfate TCP ceramics

HA ceramics

Biphasic HA TCP ceramics

Collagen matrix

stability [27,28]. In addition, it is prone to fracture when shear loaded. Nevertheless, Coetzee [29] reported excellent results in 110 patients when using calcium sulfate to repair cranial defects. He reported complete substitution of calcium sulfate with bone within 8 weeks. There have been no other reports in the literature to support these dramatic results. IV. GLASS-IONOMER CERAMICS

These are formed by sintering glass in different proportions of SiO2, Al2O3, CaF2, and AlPO4, with or without hydroxyapatite. Glass-ionomers are not resorbable,

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as bone cannot eliminate the silicate and aluminum from which they are constructed. They have been demonstrated to have good osseoconductive potential between particles, but not within them, as well as being biocompatible without causing foreign body reactions [30]. After bony ingrowth has occurred, the glass-ionomer remains permanently within the new bro-osseus matrix [31]. It remains unclear whether this enhances structural stability or whether the persistence of unresorbed foreign particles prevents restitution of normal morphology with permanent weakening of the bone. These issues are still to be resolved in long-term studies. An ovine study using a glass-ionomer as a bone graft expander in impaction grafting of the femur performed at the University of Bristol showed good clinical but poor histological results (with multiple voids within the graft and little graft incorporation) at 6 months [32].

V.

POLYHYDROXY ACIDS

Polyhydroxy acids have been used for the past 30 years to manufacture absorbable sutures such as DexonR, which is made from polyglycolic acid (PGA) [33]. Glycolic acid is a naturally occurring substance produced during normal human metabolism. It belongs to the same family of acids as lactic acid. PGA is most commonly used to manufacture multilament yarns, but a variety of substances can be manufactured, including screws [34], pins [35], rods [36], and mesh [37]. These have a wide range of clinical applications ranging from pinning wrist [38] and elbow [39] fractures to the xation of osteotomies [40]. These products have the advantage of obtaining good fracture xation and then gradually resorbing. PGA and polylactic acid (PLA) multilament yarns have been synthesized as delivery agents for bone morphogenetic proteins (BMPs). These yarns have very consistent and predictable rates of bioabsorption and thus produce a controlled delivery of BMPs. In 1995 Robinson et al. described the use of blocks of porous PGA, which structurally mimic cancellous bone, to repair calvarial bone defects [41]. Polyhydroxy acids have not been demonstrated to provide the structural support needed in high load-bearing bone, such as the acetabulum and proximal femur.

VI.

COLLAGEN MATRIX

These are formed by a combination of puried brillar collagen (usually bovine) and ceramic composed of hydroxyapatite and tricalcium phosphate. The collagen provides a structure similar to extracellular matrix, but it potentially has the same

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problems of bovine bone xenograft with regard to infection and antigenicity. Chapman et al. [42] reported raised antibody titers in 12 patients treated with a bovine collagen calcium phosphate graft material for long bone fractures. Despite this, the patients showed no ill effects. With regard to fracture healing, those treated with the collagen matrix material did as well as those treated with autograft [42]. Collagen matrix substances have also been used experimentally in animals as cranial onlay grafts [43] and to heal tibial defects in sheep [44] and rabbits [45]. Not all reports have been favorable. Muschler et al. [46] compared a collagen matrix substance to autograft when attempting spinal fusion in dogs. The collagen matrix substance performed markedly worse than the autograft. At present, these materials are available in a paste form and have U.S. FDA approval for xation of long bone fracture defects, providing they are used in conjunction with internal or external xation.

VII.

CORALLINE-DERIVED HYDROXYAPATITE

This biomaterial is derived from reef-building coral of the genus Porites. The calcium carbonate exoskeleton is converted to hydroxyapatite by means of a hydrothermal chemical exchange, while still maintaining the original microstructure [47]. The microstructure of the coral is similar to bone, with a porous structure and pore size that facilitates bony ingrowth [48]. A pore size of around 500 mm has been demonstrated to be optimal for bony ingrowth [49,50]. Coral has a low potential for infectivity [51,52] and antigenicity [53]. Coralline hydroxyapatite has been shown to osseointegrate well in rabbits [54], rats [55], dogs [56], baboons [57], and sheep [58]. It has been successfully used in humans as a space-lling material in maxillofacial surgery [59,60]. However, it is fragile and does not appear to possess the mechanical strength [61] to be used in load-bearing bone such as the proximal femur.

VIII.

ABSORBABLE CERAMICS

Ceramics are manufactured by baking or ring minerals. The ceramics most commonly used as bone graft substitutes are made of tricalcium phosphate [Ca3(PO4)2] and hydroxyapatite [Ca10(PO4)6(OH)2]. Ceramic powder is obtained by precipitation from an aqueous solution, e.g., by adding ammonium phosphate [(NH4)HPO4] to a calcium nitrate solution [Ca(NO3)2] at pH 11 12 [62]. This is then cold-pressed to form tablets. These are baked or red at a high temperature (.8008C), causing their crystals to fuse. This process, called sintering, produces a dense material with a porosity by volume of 1 5%

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(depending on parameters such as sintering temperature, sintering time, and grain distribution). A number of synthesis parameters have a profound effect on the behavior of absorbable ceramics. These include structural strength, resorption of the ceramic, and osseointegration and osseoconduction.

A.

Structural Strength

Authors are divided as to whether absorbable ceramics have the required strength to withstand the forces within the proximal femur [61,63]. Hanft et al. state: The principle limitation of calcium phosphate materials as hard-tissue implants has apparently been their mechanical properties. They go on to say, Unfortunately, these mechanical weaknesses have prevented this material from being used in cases where they must bear the initial structural load alone [64]. In rebuttal, Jarcho [63] cites compressive strength of porous calcium phosphate as similar to that of cancellous bone, while the tensile strength is 72% of the tensile strength of cancellous bone. Nonporous calcium phosphate has a tensile and compressive strength far in excess of both cancellous and cortical bone (Table 3). The structural strength would need to be determined for any particular bone graft substitute constructed from these materials. Bouler et al. [65] studied the inuence of ve synthesis parameters on compressive strength of porous biphasic calcium phosphate ceramics. These parameters were: 1. 2. 3. 4. 5. Chemical composition Percentage of macropores Mean size of macropores Isostatic compaction pressure Sintering temperature

Table 3 Compressive and Tensile Strength of Bone and Calcium Phosphate Ceramics Material Cortical bone Cancellous bone Porous calcium phosphate Dense calcium phosphate
Source: Ref. [64].

Compressive strength (103 psi) 20 69 1 10 30 130

Tensile strength (103 psi) 10 0.5 0.36 10 28

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Macroporosity and nal sintering temperature exerted the major inuences on compressive strength. Two ratios of HA to TCP were studied45% HA:55% TCP and 75% HA:25% TCP. The lower ratio of HA provided slightly better compressive strengths. Isostatic compression had comparatively little inuence on compressive strength. The more porous the ceramic, the less resistant it was to compressive forces. For a given volume percentage porosity, a few 500 mm pores were better than many 100 mm pores. When the thickness of the bridges between the pores fell below a critical size, the ceramic structure disintegrated when subjected to even low compressive forces. These ndings are conrmed by data released by SBM on their ceramic bone graft substitute (Biosorb), detailed in Table 4 [66]. Bouler et al.s study [65] also showed that compressive strength increased signicantly with a rise in sintering temperature. At 9008C, boundaries between grains of ceramic were formed. Mechanical properties of biphasic ceramics are dependent on the number and size of these grain boundaries. At temperatures between 900 and 11008C, densication (the elimination of connected and nonconnected micropores) occurred. This densication corresponded with further increase in compressive strength. Blom et al. [67] and Grimm et al. [68] designed and mechanically tested a biphasic ceramic bone graft substitute specically for use in impaction grafting at revision hip arthroplasty. Various ratios of the ceramic and allograft were compared with pure allograft. Impaction grafting was performed in a specially designed model, which was then cyclically block loaded in a servohydraulic testing machine. The load cycle was up to 20,000 cycles, with forces up to 800 N. Pure allograft subsided signicantly when loaded. When ceramic was added to the allograft, the composite was signicantly more stable. This increased stability was proportional to the amount of ceramic added. Not only did the addition of ceramic make the composite more stable, it also made the behavior of the composite more predictable (see Figure 2).

Table 4 Compressive and Bending Strength of a TCP Ceramic as a Function of Porosity Porosity (%) 5 Compressive strength (MPa) Bending strength (MPa) 150 15 30 100 10 45 15 2

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Figure 1 Histology slide showing osseointegration between a ceramic bone graft substitute and new bone. (From the authors work on the development of a bone graft substitute for impaction grafting.)

B.

Resorption of the Ceramic

The body resorbs ceramics at different rates, depending on their chemical composition and structure. Two different biological processes govern resorption: dissolution (in physiological solutions) and phagocytosis. Frayssinet et al. [69] observed both these processes causing resorption of calcium phosphate ceramics implanted into sheep bone. Multinucleated giant cells caused localized areas of resorption. In addition, a uniform dissolution was observed around the implant surfaces. Guillemin et al. observed osteoclast resorption of implanted coral-derived ceramic [70]. The dissolution of HA and TCP in both buffered acid and buffered basic solutions has been compared. The HA and TCP ceramics studied were prepared with similar structural characteristics, so that any difference in resorption would be due to their chemical compositions. The TCP ceramic dissolved 12.3 times faster in the acid and 22.3 times faster in the basic solution than the HA ceramic [71].

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Kay [72] compared the dissolution rate of various calcium phosphates in an aqueous solution at 378C and pH 7.3. TCP was 25 times more soluble than HA. Calcium phosphate was 667 times more soluble than HA. Shimazaki and Mooney compared both implant resorption and new bone formation between HA and TCP ceramics implanted into rabbit tibiae. At 24 weeks postimplantation, 46.4% of the TCP had resorbed compared with 27.5% of the HA. The HA, however, allowed 8% more new bone formation than the TCP [73]. C. Osseointegration and Osseoconduction

Calcium phosphate ceramics have an ability to bond directly to bone at a molecular level. This process is known as osseointegration. This has been noted in a number of studies [74,75]. This process does not rely on a macro-interlock. Dental studies have shown that, once osseointegration has occurred, the bond between the bone and the ceramic is so strong that attempts to separate the two usually result in fracture of either the ceramic or the bone, but rarely separation at the interface [76]. Osseoconduction is a term used to describe the growth of bone along a predetermined pathway or scaffolding. When used with reference to porous ceramic bone graft substitutes, it usually refers to bony ingrowth into the pores within the ceramic. This has two main effects. First, it allows osseointegration within the ceramic particles and not only around the periphery. Second, it allows neo-ossication within the ceramic, thereby increasing the total amount of new bone formation possible within the construct (see Figure 1). Tsugura et al. have demonstrated the importance of porosity in allowing osseoconduction [49]. High porosity is achieved in the manufacturing process by one of a number of methods, including the addition of glucose (which expands when heated and is then combusted) or the addition of hydrogen peroxide (H2O2) or naphthalene [77]. Tsugura et al. compared the same ceramic with different pore sizes, thus isolating pore size as the only variable. Their studies showed that a porosity of around 500 mm allowed greater bony ingrowth than smaller pores. Guillemin et al. [78] compared the bony ingrowth into two species of coral implanted into both ovine and porcine long bones. Porites coral resorbed twice as fast as Acropora coral and had twice the bony ingrowth. Interestingly, Porites has a mean pore diameter of 250 mm (range 150 400) and Acropora coral has a mean pore diameter of 500 mm (range 200 800). It would therefore appear that both pore size and rate of resorption of the ceramic inuence osseoconduction. Porosity also allows a greater degree of resorption to occur (by both dissolution and phagocytosis) as the surface area of the ceramic is increased. Ceramics have been used extensively as bone graft substitutes in humans. In a randomized study of spinal fusion in 341 patients, Ransford et al. obtained

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similar results with autograft and TriositeR (a ceramic consisting of 60% hydroxyapatite and 40% tricalcium phosphate) [79]. As these materials contain no proteins, they do not provoke an antigenic response from host tissue [80,81]. Porous hydroxyapatite was used to repair tibial plateau fractures in a series of 17 patients with fracture union occurring in all cases [82]. Hydroxyapatite and tricalcium phosphate ceramics have demonstrated marked osseointegration and osseoconduction, both radiologically and histologically, in a number of studies in humans and animals [83 88]. There is, however, very little experience with ceramic bone graft substitutes in impaction grafting. Blom et al. [89] compared allograft with mixtures of allograft and two ceramic bone graft substitutes in impaction grafting. Sheep underwent femoral impaction grafting with a cemented, custom-made, highly polished double-taper prosthesis. At 2, 4, 6, 12, and 18 months postoperatively, they were assessed functionally and radiologically and the bone mineral density of the impacted area was measured. At 22 months the femora were harvested and examined histologically. In all outcome measures the ceramic bone graft substitutes performed as well or better than allograft. At 22 months the ceramic demonstrated good osseintegration with a stable construct (Figure 1). The ceramic, however, seemed to obstruct retrabecularization. Retrabecularization

Figure 2 Subsidence in impaction grafting. The blue bars show pure allograft. The purple bars show a 50/50 mixture of allograft and ceramic bone graft substitute. The yellow bars show a mixture of 90% bone graft substitute and 10% allograft. (From Ref. xx.)

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was clearly visible on the specimens of pure allograft, but not on the specimens of ceramic and allograft (see Figure 4). Oonishi et al. report excellent clinical results using hydroxyapatite to ll massive acetabular [90] and femoral [91] defects at the time of revision hip replacement, despite the loads of up to 240% of body weight achieved while mobilizing with crutches [92]. An acetabular specimen of impacted hydroxyapatite granules retrieved 2 years after implantation showed osseointegration between granules and bone with bony ingrowth 20 mm into the mass of granules [93].

Figure 3 Radiograph of impaction grafting with a bone graft substitute 3 years after implantation.

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Figure 4 Radiograph from an ovine study showing ceramic granules still clearly visible 2 years after impaction grafting.

IX.

SUMMARY AND DISCUSSION

Allograft has problems of infection [94] and antigenicity [95,96]. Allograft is unpredictably variable in quality [97]. Preparing allograft is laborious, expensive, and time-consuming. It requires dedicated bone banks that pay rigorous attention to graft preparation, or the consequences can be disastrous. For these reasons attempts are being made to manufacture allograft substitutes. As yet there is no

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commercially available ideal allograft substitute suitable for use in all cases of bone stock loss. Some substitutes do not address all the problems associated with the use of allograft. For example, xenograft and collagen matrix substances can cause infection or invoke antigenicity [98,99]. Other substitutes introduce new problems. Polymethylmethacrylate and glass-ionomers are nonresorbable and nonporous, thereby preventing the restitution of normal bone morphology [100]. Calcium sulfate resorbs very quickly and thus does not provide long-term stability [101,102]. Of the types of bone graft substitute discussed above, the literature suggests that certain xenografts, ceramics, and corrallin-derived hydroxyapatites may have the requisite strength to withstand the high forces within the proximal femur. Absorbable ceramics most nearly fulll the requirements for an ideal bone graft substitute. They have low potential for infectivity and antigenicity. They can be completely reabsorbed and therefore potentially can be replaced by living host bone. They can be manufactured so that their material characteristics are uniform and reproducible. They can be manufactured at relatively low cost from a nonbiological source. They have been successfully used in impaction grafting in animals, with results comparable to allograft. Initial outcomes in impaction grafting with ceramic bone graft substitutes in humans are encouraging, but there is a need for long-term multicenter prospective randomized clinical trials comparing allograft with ceramic bone graft substitutes.

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11
The Contribution of Synthetic Bone Grafting Material to Impaction
Douglas Dunlop
Southampton University Hospitals NHST Southampton, England

I.

INTRODUCTION

Current estimates place the total number of hip replacements performed in the United Kingdom as 50,000 (worldwide .800,000) per annum, with revision rates around 15% in major centers. According to a survey of emerging technologies in orthopedics, synthetic substitutes are on the verge of expanding their current share of the market from 10% to a potential 35% in 2003 [1] as the likely demand increases. A large number of different graft types are therefore available to the revision surgeon for impaction grafting. A greater understanding of their mechanical and biological properties would be benecial before widespread adoption. Some of the mechanical and biological aspects of a few are addressed in this and other chapters. A more detailed description of the mechanical testing mentioned here is outlined in Chapter 5. Bone graft alone, either morselized or whole, has had some success in replacing lost bone stock [2 10], but limited supply and increasing concerns regarding transmission of pathogens has prompted interest in synthetic materials. There has been an increasing interest in bone substitute materials [1], which may be osteoconductive [11,12] (providing a scaffold over which bone may grow) or osteoinductive [13] (active stimulation of osteoblast activity 1+1 a scaffold), although their current use and future role have yet to be dened, together with cost-benet analysis.
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II.

MECHANICAL ASPECTS

Inert materials with high mechanical strength have been tested clinically [14 19]. Pro-Osteon, a naturally occurring material, has been investigated as a bone void ller in several studies [20]. Bone substitutes are often hard, brittle materials that may be crushed on impaction, where available space becomes an issue or, worse, causes femoral fracture or implant malposition. Constant micromotion as found in the proximal femur might subject the particles to wear and failure. The potential detrimental role of the particles as third body wear particles is as yet unreported. The addition of synthetic materials to morselized processed bovine bone [21] or fresh frozen human bone [22,23] has been shown to enhance the mechanical strength of the bone graft. This occurred in all test groups and when used as either a bulking agent or to improve the particle size distribution compared to bone graft alone.

III.

BIOLOGICAL ASPECTS

Synthetic materials are not usually osteoinductive and interlock with the host, allowing ingrowth or ongrowth along unnatural pathways. Apatite-wollastonite (A-W) glass ceramic has been used in combination with milled allograft and brin glue [15] with some success in revision total hip arthroplasty (THA). Direct bonding between bone and A-W glass ceramic granules was seen histologically. There is no replacement over time of the lost bone stock, should a subsequent revision be necessary. Interest in bioactive materials has evolved to address this problem. These include inductive agents, physical agents that can be remodeled, and cellular agents. Osteogenic protein-1 (BMP-7) is a growth factor in the TGF-b superfamily that has been shown to stimulate bone-producing cells in vitro and in vivo [24 27] and which may also enhance bone incorporation around implants. Hydroxyapatite (HA) may be an alternative to bone allograft, as it allows remodeling. Developments in tissue engineering in which amplied autogenous marrow elements are seeded onto processed/washed allograft or bone substitutes and recent developments in gene therapy [28] are providing further avenues of study. The smallest particle size allowable is problematic due to the potential to restrict neovascularization and ingrowth [29] as well as handling and third body wear problems. Experiments with particles down to 300 mm did not show neovascularization and ingrowth to be a problem [22], which is not unsurprising as capillaries are in the order of 15 mm. However, if these small particles are not

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inert, the particles with increased surface area have been shown to inhibit cellular activity due to the high local ion concentration [22,30].

IV.

IN VITRO MODELING

Previous work has shown that the addition of synthetic particles of the correct size to bone graft can improve shear strength [23]. This is because the mechanical properties of any collection of particles are more dependent upon the particle size distribution and their shape than on the individual properties of the particle material, unless there is a signicant release of lubricant uid. Synthetic additives, including nonsilicated bioresorbable glass (Corglaesw Giltech, Ayr) and a tricalcium phosphate hydroxyapatite mixture (TCP/HA, Stryker Howmedica), have been shown to uniformly improve graft strength when used as either bulking or idealizing agents (to improve particle size distribution) [21,22]. The bulking agent groups were produced as a 50/50 mixture, by volume, of synthetic agent combined with bone graft. The idealized groups were produced as bone graft from a specic mill of known particle size distribution combined with the correct amount of synthetic agent in the relevant particle sizes to make a well-graded sample. The results of shear tests are shown in Table 1. It is thought that these improvements were the result of adoption by the composite graft of the high shear resistance characteristics of the synthetic materials when tested alone. Additionally, a desiccant effect, reducing inter-particle lubrication, whereby free uid from the bone graft was adsorbed onto the synthetic materials, was observed.

V.

IN VIVO MODELING

Trials of new synthetic materials have been compared in animal model defects or revision hip simulation in animal models [22,31,32]. The graft in the defect models can be loaded or unloaded. Unloaded defects are more akin to a fracture
Table 1 Shear Test Results Interlocking (kPa) Graft & Corglaesw 50/50 Graft & TCP/HA 50/50 Graft idealized with Corglaesw 3.0 6.8 6.5 Friction angle 36.8 37.6 37.8 Shear strength (kPa) at s 350 kPa 264 277 278

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model and produce dramatically different results from revision hip simulation [22]. Loaded defects behave variably and biological and immunological factors affect incorporation rates independent of load, at least in the early stages [29]. Revision simulations appear to reproduce the mechanical as well as the biological environment and may be more relevant.

A.

Defect Model

An ovine model was used to investigate the in vivo properties of impacted TCPHA [35 38]. Aggregates, varying in chemical composition (ratio of TCP to HA) and particle size distribution (8 vs. 3 particle size ranges), were analyzed. An impactor (Fig. 1) was designed to produce 15 mm diameter pellets that were implanted in an ovine defect model. All aggregate pellets were impacted to a standard compactive effort. Eight sheep underwent implantation of pellets in 4 metaphyseal defects in both rear limbs. Treatment groups consisted of: 1. 2. 3. 4. Allograft (clinical control) 0/50 allograft/80% HA/20% TCP in 8 particle size ranges 30/50 allograft/80% TCP/20% HA in 8 sizes 50/50 allograft/80% HA/20% TCP in 3 sizes

Healing of defects was evaluated at 14 weeks with computed tomography, histology, and histomorphometry. The computed tomography (CT) density measured in all defects containing synthetic agents was higher than in defects lled with allograft alone (p , 0.01). Defects containing 8 sizes of 80% HA/ 20% TCP granules (group 2) achieved lower histological scores and contained

Figure 1 (a) Sample undergoing standardized impaction (b) pellet introduced into one of the pre-drilled defects.

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less bone than the clinical control ( p , 0.05), whereas groups 3 and 4 did not differ from the control. Although all synthetic agents were osteoconductive, the results suggest that increasing the ratio of TCP over HA and limiting the number of particle size ranges to 3 instead of 8 improves the performance of impacted aggregates as graft expanders. Evaluation under loading conditions of morselized allograft expanded with 80% TCP/20% HA (BoneSavew, Stryker Howmedica) in 3 particle size ranges is warranted. An ovine unloaded defect model was also used to examine a bioresorbable glass (Corglaesw) [22,39]. The addition of small particles to optimize mechanical strength did not inhibit revascularization. The ovine pellet model is a useful tool for evaluating new synthetic graft materials, particularly due to the reproduction of compaction, which has been shown to be an important variable [32]. It allows comparison of three test samples (Fig. 2) with a positive control, a negative control, and standard treatment (allograft). The biological environment was clearly very different from loaded graft seen in the revision hip simulation (below), which suggests that the resorption rate of Corglaesw is much more rapid in this defect model than in the revision hip scenario. Indeed, based on bone remodeling rate data, the defect model is similar in vascularity to a fracture model and as such is only similar to the most proximal environment of the femur in the revision model below. Future defect models may consider the effect of loading the graft, as this has recently been reported to have a variable effect [29,34,40]. Ideally, a revision hip simulation model should be used. B. Revision Hip Simulation Model

An ovine model to simulate femoral impaction grafting was developed [22,41], based upon a previous primary hip replacement model [42,43]. Overreaming of

Figure 2 Pellet layout in a typical randomization.

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the proximal femur produced a slippery tube, which visually appeared to emulate the proximal femur of humans, which is often encountered by revision hip surgeons after removal of the failed implant, cement, and lining membrane (Fig. 3). Two groups of ten animals were randomized to either impaction grafting with morselized allograft alone or impaction grafting with a 50/50 mixture by volume of bone graft and Corglaesw. After 12 weeks, eight animals remained in each group and the animals were euthanized. Subsequent analysis was undertaken to determine subsidence of the hemiarthroplasty, micromotion of the implant under physiological load, histology, and histomorphometry. 1. Subsidence

Instead of using roentgen stereophotogrammetric analysis (RSA), which has been described by others [44,45] along with certain complications [46,47], a simpler system was developed. We were able to reproduce the position of the femur in three dimensions over an x-ray plate with reasonable precision on the two occasions that x-rays were taken, hence reducing the need for stereo x-rays. Fortunately, as subsidence tends to be relatively large in impaction models compared to primary cemented models, the tolerable error was acceptable [measured errors (mean+2SEs): technique error 71+0.16 mm, interobserver error 74.9+0.18 mm, intraobserver error 74.7+0.04 mm). Two radiographs were taken of each animal. The rst radiograph was taken immediately postoperatively, while the animal was still anesthetized to reduce movement artefact, and the second radiograph was a contact radiograph of the ex-planted femur. A standard technique for each procedure was followed, after development of the most reliably accurate method from experimental trials. The x-rays were examined for evidence of radiolucent lines, subsidence, fracture, or other signicant abnormality [48]. Measurements from each x-ray were then taken, standardized for magnication variables, and compared. From these comparisons a measure of the degree of subsidence of the femoral component down the femur could be calculated for the 12-week period between the two x-rays. No statistical difference in subsidence was detectable between the two groups. 2. Micromotion

The stability at the time of surgery and from thenceforward of the femoral stem is a major determinant of long-term success. Relatively little movement has prevented ingrowth for biological xation [49,50]. Given that these movements are around 0.1 mm, precise measurement of stability is not a simple task, especially when the femur itself deforms on loading, providing us with the challenge of a moving target. Previous authors have often concentrated on either

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Figure 3 (a) Femoral canal prior to impaction, (b) graft introduced with open ended syringe around centralizer and (c) phantom impactor introduced.

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axial or rotational instability [43,51 55], usually due to the ease of doing so. As failure is usually a function of both of these components, ideally the threedimensional movement of the implant relative to the femur should be measured. A physiological model of the gait cycle of a sheep hind limb during normal walking was modeled. The harvested implants in their femora were tested, with the load applied through the testing jig set up to model the acetabulum and the ve major muscle groups around the hip joint dynamically to simulate pelvic movement (Fig. 4). To allow both mechanical testing and subsequent histological assessment (more ethically satisfactory), the femora in our study were tested fresh, after storage at 2708C, and then placed in a series of xative solutions for future histomorphometry. The system was validated by a microstrain assessment of the proximal femur. The load and application positions were seen to reproduce femoral microstrains within the in vivo range previously reported by Lanyon et al. [56 60] in the medial and lateral proximal femur. Two targets, one on either side/end of the implant, allowed determination of six degrees of freedom of movement of the implant relative to the overlying femur (Fig. 5). Real-time measurement during the dynamic loading cycle was performed using LASER target cubes, referenced to linear variable displacement transducers (LVDTs) on the adjacent femur (Fig. 6). This technique reduces problems of interfacial strains and other errors by adaptation of a similar reported technique [61].

Figure 4 Testing jig alignment (AP and lateral views) with X/Y table above and xed knee below, together with strap muscles (abductor, iliotibial band, adductor/ hamstrings and quadriceps with strain guage).

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Figure 5 Target set-up (a) antero-superior laboratory view (b) AP x-ray view.

Repeatability studies were performed and showed a high level of conformance. Instrument calibration showed an error of +20 mm for the LASER/LVDT coupling. There are no other reported systems that are capable of recording implant interface micromotions in three dimensions at two points simultaneously. Those that have measured three-dimensional micromotion at single points can be divided into three groups. The rst group includes that of Buhler et al. [61], who mounted their measuring device through a single drill hole and referenced the femur via this overlying drill hole. Our methodology is similar to this rst group, but our system is less compact (and hence cheaper and easier to modify) and simultaneously records data at two points. The second group comprises authors [50,62,63] who mounted their measuring devices onto the implant proximally and referenced variable points on the femur. This group may be considered rather unsatisfactory due to difculty in obtaining rigid xation to the stem and errors in the choice of the femoral reference point, which was often at a distance. Deformation in the femur during loading becomes a signicant factor with these systems. The third group comprises those authors who have used noncontact measuring devices. These authors do not clearly address the xation problem [64] and describe problems with performing experiments in total darkness [65] when using photosensitive devices (PSDs).

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Figure 6

(a) Instron set-up (b) close-up of distal targets orthogonal LASER/LVDT jig.

When interpreting the results, three bands of motion were determined prior to analysis: 1. 2. 3. ,50 mm: stable bone/cement/graft/implant 50 150 mm: probably stable/brous ingrown bone/cement/graft/ implant 150 mm: loose

Mechanical testing showed stable or probably stable implants in 15 of 16 animals, with excessive micromotion in one implant know to be infected. No statistically signicant difference between the two groups could be determined.

3.

Histology/Histomorphometry

Bone graft incorporation was common though not complete by harvest at 12 weeks postsurgery. Angioneogenesis of the graft had occurred distally, but was more rapid from the proximal end. Corglaesw was present primarily in the distal portion of the graft mantle, suggesting a more biologically isolated environment than the defect model described above. Centripetal vascularization occurred more slowly. There was no brous tissue at the cement/graft interface, suggesting stable component xation in all samples.

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VI.

SUMMARY

Corglaesw and TCP/HA appear to be worthy of consideration as potential synthetic agents. They can be used to improve graft strength by improving particle size distribution or simply as bulking agents. These agents may ultimately be used as carriers for growth promoters, which may counteract any negative effects of washing. The addition of growth factors to scaffolds, including bone graft, has been a subject of recent interest [66 70], and clinical trials are in progress.

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12
Comparative Dynamic Loading of Paired Femurs
Comparison of Freeze-Dried Versus Fresh-Frozen Bone Allografts
Bernard Godts, Ashit Bavadekar, Olivier Cornu, M. Verhelpen, and Christian Delloye
Universite Catholique de Louvain Brussels, Belgium

I.

INTRODUCTION

Arthroplasty failure is multifactorial and most often results from an interplay of biological and mechanical factors [1 8]. In assessing new implant design, new techniques of reconstruction, or different bone grafting materials, it is important to have available instruments to compare new items to standard ones. A hip simulator has the advantage of reproducing in vitro the mechanical behavior of a reconstructed proximal femur. Compared with in vivo investigation, this method is more accurate and allows variables such as load, frequency of loading, and load case to be tested in reproducible conditions [1,9]. With two hip simulator stations, it was possible to compare two methods provided that the testing devices gave comparable results. An in vitro experiment was performed to compare the initial stability of implants in a reconstructed upper femur [1 8]. The investigations were designed to analyze initial stability of a hip component under cyclic loading, measure the micromotion of a cemented prosthesis at 106 cycles, compare motion on both sides, and compare the prosthetic behavior in both femurs impacted with two different bone grafting materials. Impaction bone grafting has been advocated as a method to restore bone stock deciency during a revision hip arthroplasty [10,11]. Two different kinds of bone morsels were tested: freeze-dried
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and gamma-irradiated bone morsels (FDFH) and fresh-frozen morsels (FFFH) from femoral heads in both a short- and long-term comparative mechanical study.

II. A.

MATERIALS AND METHODS Hip Simulator

A full and detailed description of the simulator has been previously reported [12,13]. Several modications were made for this study and will be further described. In brief, a cyclical load was applied to the femur by a pneumatic actuator that acted directly on the prosthetic head. The acetabulum comprised a cup of high-density polyethylene. The loading cycle pattern reproduced force and movement following the Mshape curve close to those of a single limb phase of the slow gait cycle described by Kotzar [14] and Davy et al. [15]. Figure 1 shows a typical load-time curve. During a cycle, the maximum applied load represented 1.5 times the body weight and the minimum was xed at about 30 N, the force necessary to avoid separating the cup from the prosthetic head with each cyclical load. The loading frequency was about 1 Hz, which represents a mean of 90,000 cycles a day. One test required 10 days (240 hours) to reach a total of 900,000 cycles. The applied

Figure 1 Typical cyclic loading force acting on the femoral head. This resultant force is similar to that encountered during in vivo level walking.

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load had an angle of 208 in the frontal plane and 128 in the sagittal. The inuence of muscle force was not taken into account. Any deformation was balanced by movement of the implant and the elasticity of the bone, cement, and implant in the reconstructed femur. Two stations were available for allowing two concurrent testings. A load cell (Entran, ELF-26-5000, Les Clayes sous Bois, France) placed between the actuator and the acetabular cup measured the force applied on the femoral head. The values obtained by the load cell were validated by making 10 consecutive measures, and the observed variation was less than 2%. The load cell output was recorded to an A/D conversion card through a Wheatstone bridge. All tests were performed under load control and in real time. No preload cycle was used because it is a cyclic dynamic test.

B.

Human Material

Eleven pairs of femurs were harvested within 24 hours of death and kept frozen at 2308C until the time of testing. Five were used to validate the right and left sides of the simulator, whereas six pairs were investigated for comparison of impacted allografts. Bone quality and analysis of mineral content was performed by osteodensitometry (QDR-2000 DEXA, Hologic, Waltham, MA). Femora that varied from right to left were discarded. X-rays with lateral and antero-posterior views were taken for each pair of femora. The femur was cleared of soft tissue, wrapped in moistened bandage, and continuously irrigated during the test with 2% formalin in 0.9% saline.

C.

Prosthetic Insertion and Instrumentation

A great deal of trouble was taken to position the implant reproducibly. The femur was meticulously resected and instrumented using ancillary templates and jigs (Fig. 2). Each femur was kept upright by embedding 10 cm of the distal metaphysis in a polymer cement (Fig. 3). The symmetry of the anteversion angle was obtained with the help of a laser pointer that was xed on the prosthesis. By measuring the projection of the laser on a reference plane, the anteversion angle could be measured accurately and reproduced on the both femora. Neutral positioning of the implant in the coronal plane was achieved by implanting the prosthesis with imaging uoroscopy. Each femur was prepared for a hip replacement according to standard protocol and by the same surgeon. The femoral canal was reamed with standard rasps and washed to remove marrow and bone debris. A tightly tting bone plug was inserted in the medullary canal 2 cm beyond the distal tip of the prosthetic stem. The cement (Palacos E ow with Gentamicin, Schering-Plough, Brussels, Belgium) was injected retrograde using a pressure gun. A straight stem prosthesis

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Figure 2 The femur was osteotomized cautiously with a band saw in light of the anteversion angle and the positioning of a neutral valgus-varus angle.

with a collar (Charnley-Kerboull CMK 3, Bone and Joint Research, Luxembourg, L) was introduced 5 minutes after mixing the cement. For the comparative bone grafting material study, a cavitary bone defect was created by reaming the medullary cavity to 18 mm diameter. The proximal femoral cortex was further thinned out with broaches to allow the implantation of a 403 Charnley-Kerboull hip prosthesis. D. Bone Grafting Materials and Preparation

Osteoarthritic human femoral heads were used as grafting material. The median age of the donors was 67.5 (53 75) years. To exclude osteopenia or osteolytic lesions, femoral heads were weighed and radiographed. The femoral heads were cleared of articular cartilage [16] and soft tissue while the neck was retained. The six heads (1 6) were then cut into two halves in the coronal planeanterior (A) and posterior (P)with a band saw. Half femoral heads were weighed separately on a digital weighing scale (Mettler PE 3000, Zurich, Switzerland) (Table 1). Two groups were formed: The FFFH group consisted of halves numbered P1, A2, P3, A4, P5, and A6, which were stored frozen at 2808C (Forma Scientic Inc., Marietta, Ohio).

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Figure 3 A square is used to cement reproducibly the femur in an upright position.

The FDFH group included halves numbered A1, P2, A3, P4, A5, and P6, which were washed with a jet of distilled water to remove bone marrow and blood, treated chemically with chloroform-methanol solution for 5 days, rinsed with methanol and water [17], and nally treated chemically to prevent bovine spongiform encephalopathy (BSE). The halves from both groups were then morselized twice with the small rasps of the Noviomagnus bone mill (Spierings, Nijmegen, Netherlands). The grafts from the FDFH group were freeze-dried for 72 hours and gamma-irradiated at a 25 kGy dose. E. Impaction Bone Grafting

Prior to the impaction procedure, the freeze-dried morselized grafts were rehydrated in 0.9% saline for 30 minutes. For both the FDFH and FFFH groups,

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Table 1 Whole head Fresh-frozen (FF) half head

Origin of Material and Weight Loss on Preparation of Morselized Grafts Freeze-dried (FD) half head

Donor

Name 75 61 72 53 72 72 67.5 90.9 86.0 79.6 100.9 94.4 87.2 89.8 73.8 67.0 66.2 66.8 71.4 66.7 68.7 Post. Post. Post. Ant. Ant. Ant. 37.1 35.2 32.6 31.4 39.0 32.4 34.6

Sex

Age

Weight (g)

Weight without cartilage (g) Ant./ post. half Weight (g) Ant. Ant. Ant. Post. Post. Post.

Ant./ post. half

Weight (g) 35.0 29.8 31.8 33.6 35.1 32.5 33.0

Treated weight (g) 18.5 15.4 13.7 22.8 15.2 18.7 17.4

Freezedried weight (g) 12.5 11.3 9.4 13.5 10.2 12.6 11.6

VP PC WM DG LC TJ

M F F M M M Mean:

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the following procedure was applied. Reconstruction was carried on with the X-change revision set (Howmedica, Brussels, Belgium). An intramedullary plug was chiseled out from the resected femoral head. Impaction was performed retrograde, layer by layer, by introducing and impacting a few grams of bone morsel. The procedure was stopped when the nal impactor could not be driven any further by the operators slap hammer. Final proximal impaction was achieved using the tamps. Palacos E ow with Gentamicin cement (Schering Plough, Brussels, Belgium) was inserted retrograde in the newly constructed canal at the third minute after mixing and maintained pressurized until the fth minute. A 301 Charnley-Kerboull hip prosthesis (Bone and Joint Research, Luxembourg, Luxembourg) was cemented under image intensier control.

F.

Stability Measurement

The initial interface motion between proximal femur and prosthesis was measured by two commercial digital extensometers. One extensometer (QLR digit) measured axial motion between femur cortex and prosthesis. It had a sensitivity of 10 mm and a measure range of 7.5 mm deection around the zero position. It was xed to an aluminum frame, which was rigidly secured to the femur, just below the resection, with 10 pointed stainless screws. It reacted perpendicularly to its axis against a corrected surface of a second frame, which was xed at the prosthetic neck. No relative motion occurred between the assembly extensometer and its frame or between the frame and bone. A second extensometer (Digimatic Indicator, 543-551D, Mitutoyo, Japan) was used to measure the magnitude of the rotational movement between femur and implant. This extensometer was xed to the second aluminum frame, which was rmly secured around the prosthetic neck. It reacted perpendicularly against a corrected surface of the rst frame. It had a resolution of 1 mm and was linear up to 12.5 mm about the zero position. The xation system of these extensometers was placed just below the resection, while their opposite counterpart was just above the resection (Fig. 4). In this manner, we minimized the inuence of bone deformation. Rotational angles were calculated as arc tangent (horizontal displacement measure by extensometer/offset of the extensometer). The accuracy of this measuring system was checked by repeating 15 consecutive measurements. Motion between femur and prosthesis could be determined with an accuracy of less than 10 mm and less than 0.018. Figure 5 shows a pair of instrumented femur in simulators. Before and after each test, every pair of instrumented femurs was radiographed accurately using orientation devices to get the same projection angle and magnication factor.

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Figure 4 The implant stability was evaluated by measuring the displacement between the proximal femur and the prosthesis in both the frontal and sagittal planes by two extensometers.

G.

Denitions

The following denitions were used (Fig. 6): Axial micromotion (recoverable motion): position difference between loaded and unloaded state at each cycle Axial subsidence (unrecoverable motion): position difference between rst and current cycle with regard to the unloaded femur Total axial displacement: axial micromotion axial subsidence Rotational micromotion: difference in degree of rotation between loaded and unloaded state at each cycle

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Figure 5 This two-station hip dynamic simulator using a pair of human femora allowed the comparison of conventional prosthesis as well as new surgical techniques and new prosthesis design.

Permanent rotational displacement: degree of unrecovered rotation between rst and current cycle with regard to the unloaded femur Total rotational displacement: rotational micromotion permanent rotational displacement H. Measurements

Measurements were made every 50,000 cycles to minimize the amount of data. For each measurement, eight variables were measured on the femur: number of cycles, load, total axial displacement, axial subsidence, axial micromotion, total rotation, rotational micromotion, and rotational subsidence. Each displacement curve was modeled for statistical analysis according to the law y ax b. The parameters a and b obtained for each curve of the ve right

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Figure 6

Graph with denitions of terms that have been used.

femurs were compared with those obtained for the ve left femurs by a paired Student t-test (Systat 8.0 Data, SPSS Inc., Chicago, IL). The difference was considered statistically signicant at p , 0.02 to account for the small number of specimens and observations.

III. A.

RESULTS Cemented Prosthesis in Normal Right and Left Femurs

All specimens were carried out to over 900,000 loading cycles without failure of bone, failure of the cement mantle, or loosening of the implant. The mean displacement and standard deviation for each of the 10 femora are shown in Table 2. A typical stability curve of femoral component is presented in Figure 7. The x-axis represents the number of loading cycle, while the y-axis represents the movement of the implant. The axial subsidence, total axial displacement, and axial micromotion for the right and left femora are indicated for the loaded and unloaded situations. All specimens subsided rapidly during the rst 100,000 cycles, decreasing over subsequent cycles. The axial displacement during implant positioning had a mean value of 151+54 mm during the rst day of testing and despite a strong collar-calcar contact. The axial subsidence from 100,000 to the end of loading test was 55+57 mm. The measured total axial displacement had a mean of 181+80 mm. No signicant difference in the motion (qualitative and quantitative) between both sides was found (p . 0.1). Displacement included both movement of the prosthesis within the cement and displacement of the cement mantle in the femur. The total rotational displacement had a mean value of 0.188 (range 0.08 0.34). Comparison of variables a and b on the curves that represented axial

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Data for Five Femoral Pairs Used to Validate Right/Left Symmetry (mm)
Total axial displacement after 9 105 cycles Left Right 120 120 320 160 180 180 82 Axial micromotion after 9 105 cycles Left 90 90 130 90 90 98 18 Right 90 90 180 90 130 116 40 Axial subsidence after 9 105 cycles Left 20 20 160 80 140 84 65 Right 30 30 130 70 310 114 117 Subsidence rate Swing phase of gait Left 1 0 13 1 3 4 5 Right 3 23 10 9 33 10 13 Subsidence rate Stance phase effect Left 1 1 10 0 3 3 4 Right 8 21 16 0 0 5 7

DJ DN CJ GR HJ Mean SD

110 110 290 170 230 182 78

Implant positioning total axial displacements after 1 105 cycles Left DJ DN CJ GR HJ Mean SD 100 100 210 170 210 158 55 Right 60 130 190 160 180 144 52

Implant positioning axial micromotion Left 90 80 150 100 90 102 28 Right 50 80 140 160 130 112 45

Implant positioning axial subsidence Left 10 20 60 70 120 56 44 Right 10 50 50 0 50 32 25

displacement, i.e., subsidence, axial micromotion, and total axial displacement, showed no difference (p 0.3). Similarly, no signicant difference (p 0.5) was observed in the curves recording rotation. Figure 8 shows an x-ray of the same specimen at the rst cycle and after 900,000 cycles. No radiolucent lines were seen at either the bone/cement or the stem/cement interface. No radiological analysis was performed because motion was too minute to be measured. There was no gross failure in any of the experimental models. B. Cemented Prosthesis in Right and Left Impacted Femurs

Comparing FDFH and FFFH, 1.5 heads were used in the fresh-frozen group while 2 2.5 heads were needed in the freeze-dried group to ll a femoral defect. There

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Figure 7 The right-left symmetry is shown on this graph and represents the unloaded and loaded curves from a paired femur during 1 106 cycles.

was good implant stability throughout the experiment. All femora tolerated 900,000 cycles without bone, cement, or impacted bone graft failure. The micromotion of the prosthesis in the FDFH group (110 mm) was signicantly lower (p 0.049) than in the FFFH group (175 mm). Micromotion was not signicantly affected by the number of cycles in either the control or the freezedried group, and there was no signicant change in micromotion during the entire test. In both groups, axial subsidence of the prosthesis increased rapidly during the rst 100,000 loading cycles, as observed during right and left standardization. After initial settling of the prosthesis, axial subsidence decreased. As in axial micromotion, subsidence was lower in the FDFH group than for the FFFH group. At the end of the test, the subsidence of the implant was 265 mm (+34 mm) in the FFFH group and 81 mm (+16 mm) in the FDFH group. Analysis of variance with repeated measures showed that axial subsidence was less in the freeze-dried group than in the fresh-frozen group ( p 0.012) and that this variable was dependent on the number of cycles in both groups ( p , 0.001). From 1 105 to 9 105 cycles, the subsidence rates were higher for the fresh-frozen than the freeze-dried group (p , 0.05). The rotational micromotion of the implant was extremely small in both groups (,0.18). Very small angles of rotational migration (,0.58) were observed. They were overall smaller in the freeze-dried group (p 0.022) and had a tendency to rise during the test as it progressed in both groups ( p , 0.05). No implant migration or radiolucent lines were observed on x-rays. Implant recovery and push-out were more difcult in the FDFH than the FFFH group and

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Figure 8 On the left, the femur lled with impacted freeze-dried bone during the rst cycles is shown. On the right, the same femur after 900,000 loading cycles.

required the use of a hammer. The impacted graft layer was xed rmly enough to resist at the push-out test. It was always the stem/cement interface that failed, whereas the cement mantle was intact.

IV. A.

DISCUSSION Cemented Prosthesis in Normal Right and Left Femurs

In this study, the degree of implant stability was assessed from the immediate postoperative period up to an average 6- to 12-month period after loading equivalent to slow walking. We measured the total displacement, i.e.,

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Figure 9 Implant positioning after 1105 cycles of the six pairs of the impacted femurs.

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Figure 10 Total axial displacement after 9 105 cycles as obtained with the six pairs of impacted femurs. 171

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displacement of the stem in relation to the femur (including the relative displacement into the cement and the cement itself). The maximum load equated to 1.5 times the body weight, as suggested by Kotzar et al. [14]. Most published studies [18 22] have assessed the behavior of hip prostheses over the short term (,5000 cycles), whereas a long-term study was needed to further document implant behavior. There was comparable migration between right and left sides with a mean of 182 mm total axial displacement on the left and 180 mm on the right. The implant was stable throughout with a mean axial subsidence of 99 mm after 900,000 cycles. Several conditions were taken into account in this investigation. In contrast to studies [8,20,23] using synthetic bone, pairs of human femurs of variable size were used. Preparation was rigorous to obtain full collarcalcar contact and a reproducible setup of the femur. During the prosthesis implantation, special care was taken to obtain an average thickness and continuity of the cement mantle, as already emphasized by others [24,25]. Comparison of these results with those from other studies [21,22,26 32] must be guarded because loading conditions, measurement protocol, and testing environment were different. Nevertheless, the observed results matched those from previous studies. Loudon and Charnley [33] measured by x-ray a mean subsidence of 0.54 mm in a cemented prosthesis after one year. McKellop et al. [20] found subsidence of 0.2 mm for a cemented stem in synthetic femurs with a load of 2000 N during 5000 cycles. Walker et al. [1] found 42 mm for a cemented stem loaded statically with a force of 1000 N and a torsion of 0.0188. No fracture in the cortex or in the cement were detected by x-rays. The analysis of the cement mantle after the removal of the prosthesis showed no fracture. This suggests that it is the expansion of the cement mantle by creep that causes prosthetic subsidence. The absence of fracture conrms the results obtained by the extensometers and emphasizes the stability of the prosthesis. Most of the implant migration took place during the 100,000 rst cycles, which would correspond to about 2 months in a patients life. This early subsidence concurs with other clinical observations [34,35] where subsidence, when present, was apparent within the rst 6 months. At unloading there was a permanent migration of the implant. This can be explained by the fact that the stem was unpolished and that creep occurred in the cement. This study had the following limitations: The inuence of particulate debris was not considered [36]. Dead bone has no capacity to adapt itself to new stresses. There was no alternate rest period during which stress relaxation could occur [37].

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The effects of muscles and soft tissue were not included in this study. The applied load is only equilibrated by the elasticity of the bone. The experiment was performed at room temperature, giving more standardized observations than would occur in an actual patients life. Despite these limitations, the long-term behavior of these implants was similar on both sides and imitated the clinical observations rather well.

B.

Cemented Prosthesis in Right and Left Impacted Femurs

Throughout this study, every detail for adequate and symmetrical positioning was considered. The two displacements measured in the impacted femurs described the early stability of the prosthesis in two different settings. From a mechanical point of view, processed freeze-dried bone was superior to fresh-frozen. The implants in the freeze-dried group showed less micromotion than in the fresh-frozen one. Their subsidence as well as subsidence rate were much lower. Rotational micromotion and migration conrmed these results. It is noteworthy to observe that no loosening was found in either group. Displacements were small in this investigation and could be explained by various reasons. The loading regimen was not at the level of a full weight-bearing gait or in the range value used by others [38]. A nonpolished stem that limited subsidence of the implant into the cement mantle was used [39]. The impaction was more efcient than in an operating theater and performed on a femur rmly xed on a rigid base with no capacity to absorb shock. The alignment between the implant and the actuator was never perfect (this is technically difcult), generating a torque ranging from 0 to 5 N/m. The higher stability (less micromotion) and the lesser subsidence and subsidence rate of the stems inserted in processed freeze-dried morselized grafts was probably related to the grafts ability, when impacted properly, to create a layer that had a higher density/ compactness and hence higher modulus (see Chapter 9). This hypothesis is supported by the fact that for lling similar femoral defects, the operator had to use more freeze-dried bone (2 2.5 heads) than fresh-frozen (1.5 head). The longterm simulation (900,000 cycles) showed survival of the stability that was not compromised by cyclical loading. Previous work emphasized the importance of the time-dependent properties of the impacted grafts [40,41].

V.

CONCLUSION

In this study, we directly measured the stability under conditions that were close to the surgical procedure. The freeze-dried bone was found superior to

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fresh-frozen bone when the mechanical properties of the impacted bone were dynamically assessed using two hip simulators.

REFERENCES
1. 2. Walker PS, Schneeweis D, Murphy S, Nelson P. Strains and micromotions of press-t femoral stem prostheses. J Biomech 1987; 20:693 702. Berzins A, Sumner DR, Andriacchi TP, Galante JO. Stem curvature and load angle inuence the initial relative bone-implant motion of cementless femoral stems [published erratum appears in J Orthop Res 1995 Jan; 13(1):151]. J Orthop Res 1993; 11:758 769. Berzins A, Sumner DR, Wasielewski RC, Galante JO. Impacted particulate allograft for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of cement pressurization. J Arthroplasty 1996; 11:500 506. Sumner DR, Turner TM, Urban RM, Galante JO. Experimental studies of bone remodeling in total hip arthroplasty. Clin Orthop 1992; 83 90. OConnor DO, Burke DW, Jasty M, Sedlacek RC, Harris WH. In vitro measurement of strain in the bone cement surrounding the femoral component of total hip replacements during simulated gait and stair-climbing. J Orthop Res 1996; 14:769777. Burke DW, OConnor DO, Zalenski EB, Jasty M, Harris WH. Micromotion of cemented and uncemented femoral components. J Bone Joint Surg Br 1991; 73:33 37. Callaghan JJ, Fulghum CS, Glisson RR, Stranne SK. The effect of femoral stem geometry on interface motion in uncemented porous-coated total hip prostheses. Comparison of straight-stem and curved-stem designs. J Bone Joint Surg Am 1992; 74:839 848. Sugiyama H, Whiteside LA, Engh CA. Torsional xation of the femoral component in total hip arthroplasty. The effect of surgical press-t technique. Clin Orthop 1992; 187 193. Naidu SH, Cuckler JM, Burkholder T, Ducheyne P. Initial stability of a modular uncemented, porous-coated femoral stem: a mechanical study. Am J Orthop 1996; 25:829 834. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993; 75-B:14 21. Ling RS, Timperley AJ, Linder L. Histology of cancellous impaction grafting in the femur. A case report. J Bone Joint Surg 1993; 75-B:693 696. Munting E, Verhelpen M. Mechanical simulator for the upper femur. Acta Orthop Belg 1993; 59:123 129. Munting E, Verhelpen M. Fixation and effect on bone strain pattern of a stemless hip prosthesis. J Biomech 1995; 28:949 961. Kotzar GM, Davy DT, Goldberg VM, Heiple KG, Berilla J, Heiple-KG J, Brown RH, Burstein AH. Telemeterized in vivo hip joint force data: a report on two patients after total hip surgery. J Orthop Res 1991; 9:621 633.

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Davy DT, Kotzar GM, Brown RH, Heiple KG, Goldberg VM, Heiple KG J, Berilla J, Burstein AH. Telemetric force measurements across the hip after total arthroplasty. J Bone Joint Surg 1988; 70-A:45 50. Bavadekar A, Cornu O, Godts B, Delloye C, Van Tomme J, Banse X. Stiffness and compactness of morsellised grafts during impaction: an in vitro study with human femoral heads. Acta Orthop Scand 2001; 72:470 476. Delloye C, Allington N, Munting E, Vincent A. Lyophilized banked bone. Technique and results after 3 years of use. Acta Orthop Belg 1987; 53:2 11. Hua J, Walker PS. Relative motion of hip stems under load. An in vitro study of symmetrical, asymmetrical, and custom asymmetrical designs. J Bone Joint Surg 1994; 76-A:95 103. Malkani AL, Voor MJ, Fee KA, Bates CS. Femoral component revision using impacted morsellised cancellous graft. A biomechanical study of implant stability [see comments]. J Bone Joint Surg 1996; 78-B:973 978. McKellop H, Ebramzadeh E, Niederer PG, Sarmiento A. Comparison of the stability of press-t hip prosthesis femoral stems using a synthetic model femur [published erratum appears in J Orthop Res 1991 Nov; 9(6):933]. J Orthop Res 1991; 9:297305. Schneider E, Eulenberger J, Steiner W, Wyder D, Friedman RJ, Perren SM. Experimental method for the in vitro testing of the initial stability of cementless hip prostheses. J Biomech 1989; 22:735 744. Schneider E, Kinast C, Eulenberger J, Wyder D, Eskilsson G, Perren SM. A comparative study of the initial stability of cementless hip prostheses. Clin Orthop 1989; 248:200 209. Huiskes R, Verdonschot N, Nivbrant B. Migration, stem shape, and surface nish in cemented total hip arthroplasty. Clin Orthop 1998; 355:103 112. Dall DM, Learmonth ID, Solomon MI, Miles AW, Davenport JM. Fracture and loosening of Charnley femoral stems. Comparison between rst-generation and subsequent designs. J Bone Joint Surg 1993; 75-B:259 265. Sochart DH, Hardinge K. Comparison of the Wrightington FC hip with the Charnley low-friction arthroplasty. 10- to 15-year results and survival analysis. J Bone Joint Surg 1998; 80-B:577 584. Buhler DW, Oxland TR, Nolte LP. Design and evaluation of a device for measuring three-dimensional micromotions of press-t femoral stem prostheses. Med Eng Phys 1997; 19:187 199. Larsson S, Elloy M, Hansson LI. Fixation of unstable trochanteric hip fractures. A cadaver study comparing three different devices. Acta Orthop Scand 1988; 59:658663. Markolf KL, Amstutz HC, Hirschowitz DL. The effect of calcar contact on femoral component micromovement. A mechanical study. J Bone Joint Surg 1980; 62-A:1315 1323. Nunn D, Freeman MA, Tanner KE, Boneld W. Torsional stability of the femoral component of hip arthroplasty. Response to an anteriorly applied load. J Bone Joint Surg 1989; 71-B:452 455. Phillips TW, Messieh SS, McDonald PD. Femoral stem xation in hip replacement. A biomechanical comparison of cementless and cemented prostheses. J Bone Joint Surg 1990; 72-B:431 434.

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33. 34.

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37. 38.

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41.

13
The Inuence of Particle Size at the Femur
Is Morsel Size a Critical Parameter? Does It Inuence the Stiffness of the Impacted Layer?
Ashit Bavadekar, Olivier Cornu, Bernard Godts, Christian Delloye, and Xavier Banse
Universite Catholique de Louvain Brussels, Belgium

John Van Tomme


Royal Military Academy Brussels, Belgium

I.

INTRODUCTION

Bone mills in current practice produce morselized grafts of sizes that are more or less standardized when their mean sizes are plotted on a graph [1]. Rotating bone mills in current practice are usually equipped with coarse and ne rasps to obtain both large and small bone morsels, respectively. These morsels, when impacted in the medullary cavity of a femur during revision hip arthroplasty, form a neomedullary cavity. Clinically the outcome of a revision arthroplasty depends on the mechanical integrity of this layer of impacted graft and its ability to support a revision prosthesis as well as other factors [2 5]. Thus, we were interested in investigating the mechanical integrity of impacted grafts at various levels of impaction, keeping all other factors constant except the morsel size. The tests were aimed at establishing whether morsel size was critical in inuencing the efciency of impaction. A series of in vitro impaction tests were performed on morselized grafts of two different sizes obtained from the same rotating type of
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bone mill (Noviomagnus, Spierings, Nijmegen) currently used by surgeons at the University hospital (St-Luc University Hospital, Brussels). The literature suggests that an impacted layer of large particles would be mechanically superior, as a greater magnitude of force would be required to deform and break (impact) the large particles compared to smaller morsels. Previous experiments on impacted layers of graft [1 4,6] clearly indicate that larger morsels (particles) resist deformation on cyclical loading better than smaller ones. Small morsels give a higher elastic recoil than large ones [3]. These studies were carried out on layers of graft after an unknown number of impactions [3,4,6], which were then tested for creep and elastic recoil after loading with a cemented prosthesis. The aim of this study was to identify the changes taking place when a loose slurry of bone particles was impacted into a tightly organized material. Dynamic creep studies [3,4,6 8] suggested that morsel size would be a critical factor in determining the stiffness or mechanical superiority of layers of impacted graft. This study was done in two parts. The rst part involved a thorough particle analysis and measurement of each bone morsel included in the mechanical testing. The data were then plotted on histograms to give the reader a clearer picture of the spread of the particle size and their frequency. The second part was mechanical testing in which morsels, divided in samples of 5 g, were put through a series of in vitro impaction tests in containment. The experiments were carried out in exactly the same manner as a study done by the same team of researchers in the past to investigate if the basic tissue content of the graft inuences an efcient impaction [9]. We chose the same mechanical outcome measures: the height (or the extent of deformation) of a column of morselized graft, the stiffness (or the elastic modulus in Mpa), and the density of the grafts reached after successive impactions.

II. A.

MATERIALS AND METHODS Graft Origin

Three fresh-frozen human femoral heads from three male patients of median age 65 (53 78) years were obtained at primary hip arthroplasty for osteoarthritis. These heads were stored at 2808C in sterile conditions. Each femoral head was analyzed by plain radiography for evidence of severe osteopoenia or signicant osteoarthritic cystic lesions. B. Preparation and Sampling of Morselized Grafts

The heads were cut into the frontal plane by a band saw to obtain an anterior and a posterior half of each head. Each half head was randomly selected to be passed

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through the rotating bone mill (Noviomagnus, Spierings, Netherlands) to obtain large and small particles (Fig. 1). Half-femoral heads were weighed separately on a digital weighing scale (Mettler PE 3000, Zurich, Switzerland) before and after processing to estimate the loss of material. The femoral heads were prepared by carefully removing all articular cartilage and soft tissue but retaining the cortical neck in place on the basis of our previous research. Cortico-cancellous femoral morselized grafts without cartilage of two different sizes was mechanically tested. As small morselized grafts were more commonly used for impaction bone grafting in practice, the large particles were the test group and smaller particles represented the control. The half heads used for the smaller particles were passed twice through the bone mill separately as in surgical practice using the ne rasps of the Noviomagnus bone mill (Spierings, Nijmegen, Netherlands). The other half heads

Figure 1 Appearance of the femoral heads on shaving the articular cartilage and cutting in the coronal plane.

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used for the large particles were passed only once through the coarse rasps of the same bone mill. To randomize the samples, each type of morselized graft was mixed in a bowl and stored as samples of 5 g (Fig. 2). Eighteen samples of the different-sized morselized graft were selected randomly for the particle analysis and mechanical testing.

C.

The Analysis of Particle Prole

Each 5 g of grafts loaded in plastic tubes (Fig. 3) was analyzed one at a time for particle analysis. This commenced with thawing of the grafts for 30minutes and then laying them out on clear glass plates, avoiding any loss of material. Following this, each morsel was manually separated by a pair of microsurgical forceps. This involved a careful dissection of each morsel from any obvious soft tissue adhesions and separating it from any of its neighboring morsels. These morsels were then laid out on clear plastic plates in rows at a distance of about 0.5 mm from each other.

Figure 2 On morselization, large pieces of cortical struts (held in the forcep) resist fragmentation and remain as relatively large sized particles.

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Figure 3 Plastic tubes containing 5g of graft each. Large particulate morselized graft (left) show an initially greater height than their small particulate counterparts (right).

The plastic plates with the spread-out morselized grafts were then subjected to contact x-rays at the following exposure (0.4 mA; 12 mV for 9 minutes) after placing them on x-ray lms (Kodak 20 14 cms). The developed x-ray plates were then fed into the computer by scanning each of the x-rays separately. These images had the appearance of white polygons (the morsels) on a black background (Fig. 4). Particle analyses were done on these converted les for each sample using the perimetric area occupied by each morsel. The number of particles occurring in 5 g samples of morselized graft was calculated. Particle size was calculated as a perimetric evaluation of each morsel in mm2 using the Scionimage image analysis program downloaded from the Internet (Scion Corporation, Frederick, MD). D. Morselized Grafts in Mechanical Testing (The Impaction Procedure)

See Chapter 8. E. Mechanical Parameters

See Chapter 8.

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Figure 4 Morselized grafts spread out on plastic plates and subjected to contact x-ray for particle measurements and analysis. Particles were measured in mm2 representing their perimetric area.

F.

Statistics

The differences in the evolution of the height and elastic modulus due to the type of grafts were analyzed using repeated-measures ANOVA. The within-subject (sample) factor was the number of impactions, and the between-subject factor was the type of graft. Because the density was analyzed on different samples during the impaction, we compared the mean density of each type of graft at the four different levels of impaction considered with a two-sample t-test. These analyses were performed using SPSS 9.0 (SPSS Inc., Chicago, IL) separately for batches 1 and 2. Signicance level was xed at p , 0.05.

III. A.

RESULTS Material Weight Loss on Preparing Different Grafts

Preparing the cortico-cancellous samples by removing the articular cartilage and soft tissues adhesions from a femoral head and retaining the neck caused a mean loss of 25% (SD 2%) of material by weight. In the present era of imbalance

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between the demand and supply for tissues from bone banks [10], a loss of one quarter of the femoral head by weight would cause concern to some bone bankers. A further 2% of material is lost on passing the heads through the bone mill. This could be attributed to the loss in bone marrow with soft tissue and very minute bone morsels that are stuck on the rasps of the mill. Loss in material weight was three times more when femoral heads were passed through coarse rasps than ne rasps.

B.

Particle Analysis on Morselized Grafts

The morselized grafts presented in a malleable slurry form consist of a mixture of bone particles with soft tissue remnants, bone marrow, blood vessels, articular cartilage, and fat. To carry out the particle analysis for studying the dimensions, size, and number of morsels in a 5 g sample, every attempt was made to isolate the bone morsels. Particle analysis was carried out on 18 5-gram samples of the two morselized graft types. There were 26 (+12) large morsels and 258 (+24) small morsels of bone in each 5 g of morselized graft (Table 1). The mean particle size of morsels passed through the ne rasp was 9 mm2 and through the coarse rasp 48 mm2.

C. 1.

Mechanical Outcome on Impaction Height (Extent of Deformation)

The height of the column of a xed quantity of grafts (Fig. 5) declined progressively in proportion to the log of the number of impactions. The larger morsels occupied a greater height when lled into the impaction cylinder that the smaller morsels, which were more compact and made a shorter column. Both graft types deformed to the same extent, and their nal heights showed no signicant differences (p , 0.05). This would infer that morsel size does not interfere with the extent of deformity in the size range studied.

Table 1

Characteristics of 18 Graft Samples Mean particle size (mm2) 9 48 Mean number of particles 26 (+12) 258 (+24)

Particle type Small particles Large particles

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Figure 5 Evolution of height on progressive impaction. (Note the initial greater height of the large particles compared to the small ones.) Both grafts deform to the same extent and show no difference in compactness.

2.

The Elastic Modulus (Stiffness)

Both types of graft were rendered successively stiffer with progressive impaction, but the increase in stiffness (Emod) was different. Larger morsels seemed to reach a plateau in their stiffness at the end of the seventh impaction blow, beyond which there was a slight decline in the stiffness curve rate ( p , 0.05). By contrast, the smaller morsels got stiffer up to the 30th impaction, and beyond that there was no apparent decline in their stiffness curve (Fig. 6). All parts of these two stiffness curves were analyzed by ANOVA, but there was no signicant difference in the two moduli. 3. Evolution of Densities

Both types of graft showed the same pattern in density increase, although the smaller one was ultimately denser.

IV.

DISCUSSION

Two distinct sizes of morselized graft obtained using two different rasps showed no signicant difference in their compressive axial stiffness during progressive impaction in a contained volume. The source of the morselized grafts and their milling was similar to the actual surgical procedure. Many interesting papers have referred to the superior quality of a graft layer made up of large bone morsels compared to the smaller ones [3,4,68]. This holds

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Figure 6 Stiffness of both types of graft increased progressively with every impaction. However, at higher levels of impaction (.10), large particle stiffness declined while smaller particle stiffness continued to rise.

true when the impacted graft layer is subjected to dynamic compression and serially loaded to see its extent of deformation and recoil. Impacting the grafts deforms them to the same extent, and their stiffness is similar independent of morsel size. In this simple model for impaction, morsel size is not a critical factor during impaction, and a similar mechanical outcome can be expected on progressively impacting the grafts. If a denser layer of graft is desired with more bone content, smaller morsels are better, as more bone is packed into the same area than with large morsels. These preliminary ndings were designed to model femoral impaction, and no shear tests were performed [7]. The grafts were tested only in compression (impaction), and any inferences from the study should not be confused with the preference for large particles when reconstructing the acetabulum. Acetabular and femoral grafts are subjected to different forces, so these ndings should not be generalized. Future research is needed to test morselized grafts of different shapes, in different types of containment, and in different mechanical environments to dene the differences between femoral and acetabular impaction grafting.

REFERENCES
1. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani SP, Fairbrain DR. Mechanical consideration in impaction bone grafting. J Bone Joint Surg 1999; 81B:118 124.

186 2. 3. 4.

Bavadekar et al. Brodt MD, Swan CC, Brown TD. Mechanical behavior of human morselized cancellous bone in triaxial compression testing. J Orthop Res 1998; 16:43 49. Ullmark G, Nilsson O. Impacted corticocancellous grafts: recoil and strength. J Arthroplasty 1999; 14:1019 1023. Giesen EB, Lamerigts NM, Verdonschot N, Buma P, Schreurs BW, Huiskes R. Mechanical characteristics of impacted morsellised bone grafts used in revision of total hip arthroplasty. J Bone Joint Surg 1999; 81B:1052 1057. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993; 75B:14 21. Kobayashi et al. Comparison of morsellised grafts in compression: comparative study of grafts obtained from reciprocating and rotating bone mills. Oral Presentation at the 8th Annual EAMST meeting, Rhodos, Greece, June 6, 2001. Gosta Ullmark. Bigger size and defatting of bone chips will increase cup stability. Arch Orthop Trauma Surg 2000; 120:445 447. Griffon DJ, Dunlop DG, Howie CR, Gilchrist T, Salter DM, Healy DM. Early dissolution of a morsellised impacted silicate-free bioactive glass in metaphyseal defects. J Biomed Mater Res 2001; 58(6):638 644. Bavadekar A, Cornu O, Godts B, Delloye Ch, Van Tomme J, Banse X. Stiffness and compaction of morselized grafts during impaction: an in vitro study on human femoral heads. Acta Orthop Scand 2001; 75(5):470 476. Galea G, Kopman D, Graham BJ. Supply and demand of bone allograft for revision hip surgery in Scotland. J Bone Joint Surg 1998; 80-B:595 599.

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14
Mechanical Studies of the Bone Particle Size at the Femur
Akio Kobayashi
Osaka City University Medical School and Osaka Social Medical Center Hospital Osaka, Japan

Hirotsugu Ohashi and Yoshinori Kadoya


Osaka City University Medical School Osaka, Japan

Yuji Tanabe
Niigata University Niigata, Japan

I.

INTRODUCTION

It has been generally accepted that the polyethylene wear and subsequent osteolysis is the most critical factor causing aseptic loosening, which is the principal limiting factor in the long-term survival in total hip arthroplasty (THA). In such loose prostheses, massive bone loss in the proximal femur is frequently observed and surgical reconstruction of the defect and restoration of bone stock is the aim of revision THA. Impacted morselized cancellous allograft technique has been developed for such decient bone stock, and favorable results have been reported compared to conventional reconstruction with bone cement alone [1]. However, early and signicant subsidence of the femoral stems was also reported, which might have resulted from poor mechanical properties of the grafted bone [2,3]. Preparation of the morselized allograft and impaction technique are both considered to be important factors for the mechanical properties of the graft and initial stability of the femoral stem. However, there has been a paucity of data about preparation
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methods such as preimpaction graft treatment (wash and defating), elimination of the cartilage, and the optimum size of the bone particles. In this study, we compared mechanical properties of the graft from two commercially available bone mills in four different conditions to examine the effect of the bone particle size on the mechanical properties. Two series of studies were performed as follows: Study 1: Mechanical property of cylindrical specimens of graft was evaluated under quasi-static compression and shear with special reference to the range and distribution of particle sizes, and the number of dynamic impactions. Study 2: Axial and torsional load tests were performed on femoral stems xed in model bones with bone cement on to impacted morselized graft.

II. A.

STUDY 1 Graft Bone Preparation

Seventy-ve human femoral heads were obtained from patients with femoral neck fractures (47 patients) and osteoarthritis (28 patients) during primary THA. The femoral heads were stored at 2708C until tested. After removing soft tissue and cartilage, the femoral heads were cut equally into four pieces and divided into four groups at random to minimize heterogeneity among the groups. Morselized allografts were prepared in four different conditions made by two types of bone mills of the rotating rasp type (Tracer Designs, Santa Paula, CA) and reciprocating blade type (Recipro) (Lere Bone Mill, DePuy, Warsaw, IN). In the rotating type, three kinds of rasps were used: coarse, medium, and ne (Fig. 1). B. Measurement of Particles Size of Morselized Graft

To determine the size of the bone particles, seven specially designed sieves were made of plastic plates with drilled holes. The size of the drill holes ranged from 2 to 8 mm with 1 mm increment. The sieves were used in order of decreasing hole diameter with the largest at the top. Approximately 500 mg of morselized bone was rst washed in ethanol in order to remove fat and prevent aggregation, then passed through the sieve with the largest holes. The sieve was manually shaken until there was no further passage of fragments. The same procedure was applied to the other sieves. The weight of the graft bone remaining in each sieve was measured, and the percentage of the graft in each sieve was calculated. This procedure was repeated four times to process the four quadrants.

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Figure 1 (a-1) Rotating rasptype bone mill with (a-2) three kinds of rasps (coarse, medium, and ne). (b) Reciprocating blade type bone mill.

C.

Evaluation of the Impact Force Using Operating Devices

The magnitude of an impact force was calculated based on the one-dimensional elastic wave propagation theory [4] in a simulated operation using morselized allograft and plastic model bones (Sawbones, Pacic Research Laboratories, Vashon, WA). We used exactly the same devices and procedure as used clinically (CPT, Zimmer, Warsaw, IN). Two sets of strain gauges were attached on the femoral packer, as shown in Figure 2. The impact force (Fc) applied to the upper end of the bone at any time (t) could be calculated by the following equation: Fc A{sa (t t1 ) sa (t t1 ) sb (t)} where sa , sb stress histories detected by strain gauges at point a and b (Fig. 2), respectively A cross-sectional area of the femoral packer t1 time required for stress wave propagation from point a to b or from point b to a Ten consecutive impacts were applied for each trial procedure, and the impact force was standardized during the rst 10 impacts. Thus, we chose the value at the tenth impact as a representative value for each trial. The average after ve experiments was 4.2 kN.

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Figure 2 The femoral packer. Strain gauge (a, b) location is shown on the schema (L1 L2 L3). Four-gauge method was used to evaluate impact load applied to the graft.

D.

Production of Cylindrical Bone Specimens by Dynamic Impaction

Cylindrical graft specimens 10 mm in diameter and 10 mm in length (Fig. 3) were prepared by a specially designed dynamic impaction apparatus (Fig. 4). The apparatus consisted of a striker bar, a force transmitter bar, a setting table, and recording equipment. Approximately 500 mg of the morselized bone was packed into the hole of the setting table and the force transmitter bar was placed

Figure 3

Cylindrical graft bone specimen.

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Figure 4 A specially designed dynamic impaction apparatus.

on it. The striker bar struck the upper end of the force transmitter bar generating a pulse of compressive force traveling down it dynamically loading the morselized bone. The magnitude of an impact force selected was the same as that observed in the simulation described in the previous section and set at approximately 4.2 kN by monitoring with strain gauges on the force transmitter bar. The impact force was applied to the bone 15 or 30 times to investigate the effect of the number of impactions on the mechanical properties of the graft preparations.

E.

Mechanical Testing

Quasi-static uniaxial compression tests as well as quasi-static shear tests at various normal compression loads were performed using an Instron-type materials testing machine (Autograph AG-25TD, Shimadzu Co. Ltd., Kyoto, Japan). The specimens were tested without lateral constraint in the compression tests. A new shear testing apparatus modied from the commercial one used in the previous study [5] was made for this study (Fig. 5). The cylindrical bone specimen was put into a cylindrical plastic container with a load of 9.8, 19.6, or 29.4 N applied by a spring and then sheared by moving the cross-head downward at a constant speed (3 mm/min) at room temperature (208C). All specimens were kept moist during testing. Ten specimens were used for each test and each graft group. The results were statistically analyzed among four groups of bone specimens using ANOVA with a statistical software program (SPSS Inc., Chicago, IL).

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Figure 5

Experimental set-up for quasi-static shear tests.

F. 1.

Results Particle Sizes in Morselized Bone

The size distribution of bone particles in each group is shown in Figure 6. Compared to rotating rasps (coarse, medium, and ne), morselized bone prepared by the reciprocating blade (Recipro) contained larger bone particles with greater size distribution.

Figure 6

Percentage size distribution of graft bone for different milling conditions.

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2.

Stress-Strain Behavior of Impacted Bone Specimen Under Compression

Nonlinear or downward convex characteristics were found in nominal compressive stress-strain curves of all specimens independently of the number of times they were impacted. Stiffness in compression dened by the tangent modulus at strain of 0.2 on the stress-strain curve in each group is shown in Figure 7. The stiffness generally increased in proportion to the number of impactions in each group, but the difference between 15 and 30 times was not signicant in every group. After 30 impactions, specimens prepared by the reciprocating blade (Recipro) showed signicantly higher stiffness than those prepared by any other rotating rasp (coarse, medium, and ne) (p , 0.01). 3. Mechanical Strength of Impacted Bone Specimen Under Shear

Load-displacement curves of all specimens under quasi-static shear obtained in this study were upward convex. Shear strength, dened as the maximum shear stress on the curve, was determined as a function of axial compressive stress (Fig. 8). As the number of impactions had no effect on the relationship between

Figure 7 Stiffness of cylindrical bone specimens in quasi-static compression for each graft group.

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Figure 8 Shear strength of cylindrical bone specimens impacted 30 times plotted against axial compressive stress.

shear and axial compressive strength, only the results for the specimens impacted 30 times are shown in this study. The average of shear strength can be formulated by the Mohr-Coulomb equation [5,6] given as tu c sa tanf where (1)

tu shear strength sa axial compressive stress c cohesive force f angle of shearing resistance or angle of internal friction
The shear strength parameters, c, f, and tu , of each group are listed in Table 1. Impacted bone specimens prepared by the reciprocating blade (Recipro) showed signicantly higher shear strength than those prepared by any other rotating rasp (coarse, medium, and ne) ( p , 0.01).

Bone Particle Size at the Femur Table 1 Shear Strength Parameters for Eq. (1)

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Group Fine Medium Coarse Recipro


a

Cohesion (c) (MPa) 0.34 0.22 0.28 1.07

Angle of internal friction (f) (rad) 0.38 0.46 0.48 0.25

Average shear strength (tu ) (0.37 MPa compressive stress) (MPa) 0.49 0.37 0.46 1.27a

p , 0.01 compared to the other three groups.

G.

Summary

The results of study 1 indicated that the mechanical properties of cylindrical specimens were affected by the preparation method of morselized bone and the number of impactions. The size distribution varied among the four types of bone mill. The main factors that inuenced the mechanical properties of impacted morselized bone were not identied, but the samples with larger bone particle size and/or broader particle size distribution seemed to have superior mechanical properties.

III. A.

STUDY 2 Preparation of Femoral Models

The mechanical characteristics of impacted morselized allograft were assessed in more clinically relevant conditions. Plastic model femora (6 in each group) (Sawbones, Pacic Research Laboratories, Vashon, WA) were overreamed (15 mm in diameter at the distal end of the femoral stem) (Fig. 9) to reproduce the bone decit seen in aseptic loosening. Four kinds of morselized allograft were prepared under the same conditions as used in study 1. The impaction allograft procedure was performed exactly like an operative procedure with specially designed instruments (CPT, Zimmer, Warsaw, IN). Collarless polished tapered femoral stems (CPT, Zimmer, Warsaw, IN) (Fig. 10) were cemented into the impacted bone bed with acrylic bone cement (Fig. 11).

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Figure 9 Plastic model femur over-reamed by 15 mm in diameter canal reamer to reproduce the bone-decient condition.

B.

Mechanical Testing

Cyclic compression and torsional tests were performed using Instron-type mechanical tester (Autograph AG-25TD, Shimadzu Co. Ltd., Japan) (Fig. 12). Cyclic loading was applied between 440 and 690 N at a frequency of 0.4 Hz up to 200 cycles. In this test, stiffness and absorbed energy were calculated from the relationship between load and displacement of the stems. Stiffness was dened as the Youngs modulus of the loading curve. Absorbed energy was dened as the area surrounded by the loading and unloading curves at given cyclic compression. Torsional test was performed with

Figure 10

Collarless polished tapered femoral stems (CPT).

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Figure 11 cement.

CPT xed into the reconstructed femoral canal with acrylic bone

an axial load of 440 N at angular rate of 2.0 degrees/s. Stiffness in torsion was dened as the tangent modulus at 14 degrees of the twist angle in torque-twist angle curve. Results were statistically analyzed among four groups using ANOVA with a statistical software program (SPSS Inc., Chicago, IL).

C. 1.

Results Cyclical Compression Test

The greatest subsidence was seen during the rst 50 cycles, but stems became stable afterwards. The differences among the four groups were not statistically signicant (Fig. 13). Stiffness in the Recipro group was signicantly higher than in the rotating rasp groups (coarse, medium, and ne) ( p , 0.01) (Fig. 14). Absorbed energy in the Recipro group was also smaller than in rotating groups (p , 0.01) (Fig. 15).

2.

Torsional Test

Stiffness in the torsional test showed a similar tendency as seen in compression test, but the differences between bone mill types were not signicant (Fig. 16).

D.

Summary

These ndings indicated a similar tendency as observed in study 1. The femoral stems xed with morselized bone containing large bone particles were more stable under compressive and torsional conditions.

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Figure 12

Experimental set-up for cyclic compression test and torsional test.

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Figure 13 Axial displacement (subsidence) under cyclic compression. The differences among groups were not signicant (NS).

Figure 14 Stiffness under cyclic compression. In Recipro group, stiffness was signicantly higher than those in rotating rasp groups (coarse, medium, and ne).

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Figure 15 Absorbed energy under cyclic compression. In Recipro group, absorbed energy was smaller than those in rotating groups (coarse, medium, and ne).

Figure 16 Stiffness in torsional test. A similar tendency was seen as in compression test, but the differences among groups were not signicant.

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IV. A.

DISCUSSION Experimental Procedure

Several studies have been done on the mechanical behavior of morselized graft in vitro. In some recent reports, morselized graft was considered to be a particulate aggregate, and its mechanical behavior was characterized by engineering soil mechanics [5,7]. Giesen et al. [8] and Bavadekar et al. [9] analyzed the mechanical properties of the graft in a contained cavity under compression simulating the clinical conditions in the femoral canals. Malkani et al. [10] and Berzins et al. [11] used cadavers to reproduce the impaction grafting procedure. In the current study, however, plastic model bones were used. The mechanical properties of the model bones were considerably different from that of human femora, and the denite values of the result in our study 2 might be inuenced by this difference. However, the authors believe that the comparison among the groups is still valid and provides useful information. In fact, there is a denite advantage in using the model bones. The model bones are more consistent than cadaveric bones, and thus it is easier to reproduce the bone defect in the proximal femur to standardize the experimental conditions. B. Inuence of Bone Preparation Condition on Mechanical Properties of the Graft

Clinically, it is practically difcult to obtain pure cancellous bone as the source of morselized allograft. Contamination of some soft tissue, cartilage, and cortical bone is inevitable. Bavadekar et al. [9] compared the mechanical behavior of pure cancellous and cortico-cancellous bone and revealed that there was no difference between them, reporting that the contamination of the cartilage weakened the stiffness of the graft specimens. Ullmark [12] and Hostner et al. [13] assessed the effect of washing and defatting on morselized bone before impaction and discovered that they strengthened the impacted specimens. C. Inuence of Particle Size of Morselized Graft

There have been few reports on the inuence of bone particle size on the mechanical properties of the graft. Brodt et al. [7] sieved the morselized bone and divided it into three size range groups (,0.53 mm, 0.53 1.14 mm, and 1.52 2.46 mm), showing no difference among the groups. Ullmark and Nilsson [14] compared two different bone mills (particle volume range up to 40 mm3 and up to 12 mm3), and larger bone chips had superior mechanical properties. In our study the Recipro group, which included both larger bone particles and a wide range of size distribution, demonstrated superior mechanical properties. This is exactly

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Figure 17 A stone wall in Himeji Castle, Himeji City, Hyogo, built in 1609, a national treasure and World Heritage site. Broad size distribution may provide a stable structure.

like the stone walls of ancient Japanese castles, which survived despite exposure to repeated earthquakes (Fig. 17). Morselized bone prepared by the reciprocating blade type bone mill contained larger bone particles with a wide variation of size and showed signicantly higher stiffness and shear strength compared to those prepared by rotating bone mills. Although there were no signicant differences in torsional tests among the bone mill types, the tendency to superior stability in the Recipro group was demonstrated, indicating that the selection of bone mill is very important when using impaction morselized allograft for revision total hip arthroplasty.

REFERENCES
1. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993; 75-B:14 21. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early subsidence following femoral impaction grafting. J Arthroplasty 1997; 12:535 540. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction bone grafting in revision hip surgery. A high incidence of complications. J Bone Joint Surg 2000; 82-B:103 107.

2. 3.

Bone Particle Size at the Femur 4.

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12. 13.

14.

Tanabe Y, Kobayashi K, Sakamoto M, Hara T, Takahashi H. Identication of the dynamic properties of bone using the Split-Hopkinson pressure-bar technique. Biomaterials Mechanical Properties, ASTM (American Society for Testing and Materials, Philadelphia) 1994; STP1173:127 141. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR. Mechanical considerations in impaction bone grafting. J Bone Joint Surg 1999; 81-B:118 124. Craig RF. Soil Mechanics. 5th ed. London: Chapman and Hall, 1993. Brodt MD, Swan CC, Brown TD. Mechanical behavior of human morselized cancellous bone in triaxial compression testing. J Orthop Res 1998; 16:43 49. Giesen EBW, Lamerigts NM, Verdonschot N, Buma P, Schreurs BW, Huiskes R. Mechanical characteristics of impacted morsellised bone grafts used in revision of total hip arthroplasty. J Bone Joint Surg 1999; 81-B:1052 1057. Bavadekar A, Cornu O, Godts B, Delloye C, Van Tomme J, Banse X. Stiffness and compactness of morselized grafts during impaction: an in vitro study with human femoral heads. Acta Orthop Scand 2001; 72:470 476. Malkani AL, Voor MJ, Fee KA, Bates CS. Femoral component revision using impacted morsellised cancellous graft. A biomechanical study of implant stability. J Bone Joint Surg 1996; 78-B:973 978. Berzins A, Sumner DR, Wasielewski RC, Galante JO. Impacted particulate allograft for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of cement pressurization. J Arthroplasty 1996; 11:500 506. Ullmark G. Bigger size and defatting of bone chips will increase cup stability. Arch Orthop Trauma Surg 2000; 120:445 447. Hostner J, Hultmark P, Karrholm J, Malchau H, Tveit M. Impaction technique and graft treatment in revisions of the femoral component: laboratory studies and clinical validation. J Arthroplasty 2001; 16:76 82. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength. J Arthroplasty 1999; 14:1019 1023.

15
Impaction Grafting: How Does It Work?
Magnus Tagil and Per Aspenberg
Lund University Hospital Lund, Sweden

I.

INTRODUCTION

The initial problems in hip arthroplasty with infection, poor implant design, and fatigue fractures of the implant have essentially been solved, and some authors even doubt the need for further research in these elds [1]. However, the problem of what to do when prosthetic loosening occurs remains. The results of revision surgery are not as good as those of primary replacements [2,3]. When there is major bone loss, bone grafts are used in the proximal part of the femur or the acetabulum. Autogeneic and allogeneic structural grafts have been used in the acetabulum with good initial results [4], but resorption of the graft and subsequent loosening of the implant have been reported to occur later [5,6]. Others have reported more favorable mid-term results with a similar technique [7]. On the femoral side, good short- and medium-term results have been obtained with structural grafts [8 10]. In the late 1970s, the Slooff-Ling technique, named after its inventors, was introduced (Figs. 1 and 2), based on Hastings and Parkers [11] operation for acetabular protrusion in rheumatoid arthritis. Hastings and Parker placed an autograft in the acetabulum and cemented a cup with a vitallium mesh between the graft and the cement. In 1978 Slooff started to use this method for acetabular component loosening with osteolysis. Instead of the autograft, he used allograft chips, which were impacted into the acetabular cavity, and a cup was cemented directly onto the graft. The results were reported in 1984 [12]. One year later, Ling started to use the same technique for femoral reconstructions [13]. With this
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Figure 1 Schematic drawing of a femoral revision with morselized and impacted graft between the cortex and the cement.

technique, the bone chips are impacted with a phantom into the femoral canal. A cavity is produced, surrounded by a layer of tightly impacted allograft chips forming a compact lining of the thin cortical walls (Fig. 1). The graft is contained within the cortex of the femur. A cemented prosthesis is then inserted in the same way as in a primary hip replacement with the cement pressurized into the graft during cementation. Theoretically, the impacted allograft would be expected to fail. A large volume of necrotic tissue placed under high mechanical stress should resorb and collapse, just as the necrotic bone collapses after avascular necrosis of the hip or

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Figure 2 (A) Hip revised with impaction grafting. The marrow cavity was cleansed of soft tissue and bony debris and lled with morselized allograft, which was impacted with a phantom. A prosthesis was cemented into the cavity surrounded by a wall of impacted bone within the thin cortex. (B) The postoperative radiograph (left) shown in higher magnication. Note the thin cortex. (C) One year after the operation, the cortex looks thicker.

knee, without being able to maintain its volume during healing and remodeling. Moreover, the morselized and impacted graft is of allogeneic origin, and an immunological reaction with activation of macrophages and osteoclasts would further enhance the resorption and lead to graft collapse and loosening again. Compared to the rather drastic introduction of a 0.5 1 cm thick layer of necrotic tissue, much more subtle changes in the periprosthesic tissue have been incriminated as the cause of aseptic loosening, e.g., heat necrosis, brous layer development, and inammatory cytokines. However, the clinical results of the Slooff-Ling technique are good in the hands of the innovators, with re-revision rates no higher than after a primary

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arthroplasty [14 16]. Others have also reported good short- and mid-term results with this method, but poor results have also been noted, raising concerns over a high rate of subsidence [17 19]. II. HYPOTHESES

Why does the method of using morselized and impacted allograft work so well? Often, when the clinical need for a solution is great, clinical trials start before the theoretical basis of the method is clear. Ingrowth of host bone into a large, structural, nonmorselized allograft is usually limited to a few mm [20 23], whereas in the morselized and impacted graft a distance of at least 10 mm in the trochanteric region is considered to be remodeled or in the acetabulum even more. Why should a thick layer of morselized necrotic, allograft bone become better incorporated, without causing the resorption and recurrent loosening often encountered in structural grafts? Several years ago, we decided to test three hypotheses that we thought could explain the excellent long-term results of impaction grafting: 1. 2. Impaction improves the osteoconductive properties of the graft. The production of a large fracture surface area by fracturing the bone during morselization permits release and access to biologically active substances in the graft. The compliance of the impacted graft enables mechanical load to cause deformations, which stimulate bone formation.

3.

III.

IMPACTION AND INGROWTH

Does impaction improve osteoconduction and enhance ingrowth into the graft? Theoretically the ingrowing tissue could benet from a decreased distance between the graft trabeculae, the network being more dense compared to a cancellous graft but without the transient weakening of a cortical graft during remodeling. The morselized and impacted graft could be seen as the ideal grafting material, being an intermediate between cortical and cancellous graft, and combining the advantages of both [24]. To study the remodeling of an impacted graft in an animal model, we developed an impacting device consisting of a hollow cylinder and an impacting piston. Two cancellous rat bone grafts were manually impacted into approximately the size of one. This procedure increased the volume fraction of osseous material in the graft from 35% to 65% (Fig. 3) (25). The bone conduction chamber (BCC) (Fig. 4) rat model was used, and impacted and unimpacted grafts were compared for bone ingrowth distances after 6 weeks. A striking reduction of

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Figure 3 (A) Structural graft (left) before insertion into the chamber, with unfractured trabeculae, fat, and marrow cells. (B). Impacted bone graft (same magnication) before insertion, with fractured trabeculae and reduced intertrabecular space. Smaller amount of fat and marrow cells are present than in A. (Reproduced by permission of Clinical Orthopedics).

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Figure 4 The bone conduction chamber. (A and B). The bone conduction chamber (BCC, Aspenberg and Wang, 1993) is screwed into the proximal tibia of a rat. The interior of the chamber is a standardized space of 2 7 mm. Tissue can grow into the chamber from the osseous compartment via two ingrowth openings (arrows) at one end, but not from the surrounding soft tissues. The interior can be left empty and the chamber lls with mesenchymal tissue, which gradually differentiates into bone. The chamber can also be lled with an osteoconductive material, which can be further processed using growth factors, defatting, etc. Bone grafts were prepared from donor rats by resecting a 2 6 mm cancellous bone rod. The impacted graft consisted of two graft pieces compacted into the size of one using an impactor. The grafts were then inserted into the chambers, which were then screwed into the proximal tibias of recipient rats. After harvest, the grafts were taken out, decalcied, cut and stained with hematoxylin and eosin. (C) The area of newly formed bone was measured histomorphometrically by circumscribing it on a digitizing table, using a computerized video system. The area (A) was divided by the width (W) of the specimen to obtain the mean ingrowth distance (I) of new bone in each specimen. All rats had chambers implanted bilaterally; one side serving as the experiment side and one as the control side. Paired statistical tests were used to analyze the data.

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Figure 4 Continued.

bone ingrowth into the graft was found due to the impaction, not an increase as hypothesized [25]. To determine whether the ingrowth was permanently reduced or only delayed, we studied the ingrowth of new bone into an impacted graft at both 6 and 12 weeks [26]. A reduction in ingrowth was again found at 6 weeks, but no detectable difference between the impacted and the structural grafts was found at 12 weeks. We found no support for the concept that impaction would increase the ingrowth or remodeling per se. On the contrary, remodeling was decreased or at least retarded.

IV.

IMMUNOGENICITY

It has been speculated that the amounts of immunogenic cells and cell remnants are minimized in the morselized and impacted graft, because most of the marrow is squeezed out [15]. Since the graft is of allogeneic origin, the immunogeneic host-graft reaction is minimized, which could be benecial for the remodeling. In animal studies, cancellous bone, containing marrow, was more immunogenic than cortical bone, and removal of the marrow reduced the immunogenicity [27 30]. In the BCC model, chemical lipid extraction of structural grafts

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Figure 4 Continued.

increased the bone ingrowth distance in structural grafts [31]. Perhaps the morselization and impacting procedure can be regarded as a mechanical defatting procedure comparable to a chemical one, which we know is benecial. Our impacted bone pellets had reduced amounts of fat and marrow cells (Fig. 3). However, in two further series of experiments, impaction decreased bone ingrowth in both syngeneic and allogeneic grafts [26]. Thus, although impaction may reduce marrow content and thereby immunogenicity, ingrowth due to impaction decreased in the BCC model.

V.

FRACTURE SURFACE AND ENDOGENOUS PROTEINS

Bone graft incorporation appears to mimic fracture healing, and local regulatory factors are probably important for activating local cells and regulating the release

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of biochemical messengers [32,33]. Hippocrates suggested an endogenous product, able to heal bone, to be present in the human body [34]. A fresh fracture surface exposes the bone matrix to the surrounding tissues without a protective layer of lining cell and osteoid. Do the fracture surfaces created by morselization have a growth-promoting effect by permitting the release or presentation of bone morphogenic proteins (BMPs) or other growth factors within the mineralized matrix that would not have been released if the lining layer was intact? Bone matrix contains growth factors that modulate osteoblast differentiation [35], but it is not known whether the endogenous proteins from the graft play an active role in incorporation and remodeling, although their presence has been emphasized [36 38]. Exogenously added growth factors accelerate healing in numerous animal and human studies. In different bone chamber models exogenously applied bFGF [39,40], BMP-7 [26], and BMP-2 [40] accelerate and increase ingrowth into bone grafts. To establish whether the endogenous proteins present in the bone matrix would inuence the remodeling of a bone graft, we produced grafts in which these proteins were destroyed. Femoral and tibial diaphyses from rats were defatted and ground. One portion was slowly heated with water to 2708C at an autogenic pressure of 55 bar for 4 hours (a ceramic procedure) in order to destroy the proteins of the graft but leave the mineral phase of the bone unchanged. As a control, similarly ground but not heated bone powder was used. The rat bone conduction chamber was used, and the ingrowth distance of new bone into the graft was studied (Fig. 4). The ingrowth of new bone was reduced when the proteins were destroyed. The hypothesis that the morselization procedure would release or present growth factors at fracture surfaces was consistent with this nding. However, other effects of persisting proteins might be responsible, for example, proteins as a substrate for cellular attachment.

VI.

IMPACTION AND EXOGENOUS GROWTH FACTORS

In a study of spinal fusion in rabbits using morselized autograft bone, the central grafted volume of the fusion mass was compared to a more peripheral one, and the extent of healing differed in relation to the distance into the graft [41,42]. Peripherally in the graft, the healing was faster and the mechanical strength showed an earlier increase than in central parts of the graft, where healing was slower and did not become complete. The authors discussed whether the central graft is compromised geographically and concluded that, if the molecular events responsible for the delay in the central zone could be controlled, this might be the key to eliminate nonunions. Using RT-PCR, different gene expression patterns were found in the central and peripheral parts of the graft [43]. The peaks of gene expression in the central zone lagged 1 3 weeks behind the peripheral parts of the graft. This correlated to the delay in bone formation, seen

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histologically, and the fact that nonunions, which occur in 35 45% of rabbits in this model, do so in the central fusion mass. Addition of a rhBMP-2 lowered the nonunion rate to 0% [44]. Gene expression analysis of the BMP-treated fusion mass showed a marked increase in BMP-6 in the outer zone as well as elimination of the central lag of BMP-6, BMP-2, collagen, and osteocalcin [43]. In our BCC model, the markedly decreased ingrowth caused by impaction was also reversed by adsorbing a BMP (OP-1) to the impacted graft [26]. The ingrowth was even greater than in the unimpacted grafts in the other groups. The effects of osteoinductive proteins on the osteoblasts have been studied extensively. In our study and in the rabbit spine fusion study [43], the osteoclastic resorption might have been increased by an osteoinductive substance as suggested by some studies [40,45,46]. Increased resorption would then compensate for a relative blockade of tissue from intruding between the packed trabeculae. This blockade could be related to the reduced porosity of the graft. The effect of OP-1 might be to overcome this blockade by stimulating osteoclastic resorption. This would permit the ingrowing new tissue to extend further into the graft.

VII.

BONE REMODELING IN RESPONSE TO LOAD

Our bone chamber studies were designed to separate various factors and mechanisms to nd impaction-related factors that increase bone ingrowth into the graft. Such an increase would have been possible to measure as increased ingrowth distance of new bone into the graft. Unexpectedly, we found a decrease or delay with impaction and not an increase. We therefore had to nd another explanation for the good clinical results with impaction grafting. The better clinical results with the impacted grafts than with structural grafts have been ascribed to a better response to mechanical stimulation. Gie et al. [13] suggested that the load is directed through the graft during healing. Load would increase remodeling just as an externally applied growth factor would. Indeed, mechanical stimulation of graft incorporation might be mediated by increased production of growth factors [47]. A rabbit knee prosthesis model was designed to study the effect of a mechanical load on the remodeling process [48]. In that model, a loaded or unloaded tibial prosthesis stem was inserted into the impacted graft (Fig. 5). In consequence, the graft into which the stem was inserted was either mechanically stimulated or not. In the loaded stems, the knee joint forces acting on the tibial plateau of the prosthesis loaded the graft surrounding the stems with each step. In the unloaded stems, the tibial tray was cut off, leaving only the stem, and the articulation took place between the remaining articular surfaces.

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Figure 5 Rabbit knee prosthesis model. (A) A tibial prosthesis was designed for this experiment and implanted in skeletally mature lop-ear dwarf rabbits. The prosthesis consists of a titanium plate replacing the tibial surface and a 25 mm long, conical shaped, unpolished stem. The articular surface is convex in the sagittal plane and tilted posteriorly. (B) In the unloaded experiments, stems without a bearing surface were inserted into the graft bed. The femoral condyles then rested on the remainder of the tibial articular surface, without transferring a load onto the prosthetic stem and the impacted graft. No cement was used for xation. Cancellous bone grafts were harvested from donor rabbits and manually cut into 11.5 mm pieces and frozen. The bone marrow cavity was enlarged, and all cancellous bone removed. A distal rubber plug was inserted into the marrow cavity 25 mm down, and the space between the stem and cortex was lled with graft and impacted with a prosthesis. Either the complete prosthesis or only the intramedullary stem was then inserted and, consequently, the bone graft surrounding the stems was either loaded or not. (C) After harvest, the bone was sawed into segments perpendicular to the tibial axis and were decalcied, cut, and stained with hematoxylin and eosin. Four segments, at a distance of 4 mm, were blinded and analyzed from each animal. In all sections, the inner 0.9 mm, the area of interest (boxes) at the three sides to the triangular-shaped stem void, was examined by a Merz grid. The percentages of new bone, remaining dead graft, and other tissues were recorded. The means of the three regions of interest in each section were calculated, and the means of all four segments were then used to yield one nal value for each animal. The ndings were analyzed by t-test.

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Figure 5

Continued.

In this model, the load increased the remodeling of the graft. Both formation of new bone and resorption of the graft were increased. Around the unloaded stems, the proximal metaphyseal bone remodeled to some extent, but in the diaphyses, the graft was mostly resorbed without much formation of new bone. In a second series OP-1 was added to the morselized and impacted graft to see if one could speed up the remodeling even more but no increased remodeling was found [49]. However, just like the chamber model, this rabbit prosthetic model cannot detect an increased ingrowth distance or penetration of new tissue into the graft, exceeding the 2 3 mm mentioned previously [20], because the distance from the cortex to the prosthesis is too short.

VIII.

THE FATE OF THE IMPACTED GRAFT DURING REMODELING

Thus, we could conclude that mechanical stimulation is important for the incorporation and remodeling of a morselized impacted graft. However, a prerequisite for all grafting procedures is initial and permanent mechanical stability, essential for graft-host union and further remodeling. In structural nonmorselized grafts, some authors have stressed that instability may lead to fatigue fractures and nonunion can cause the graft to resorb [50]. In the morselized graft, stability, in spite of its nonstructural appearance, is also important. A morselized graft in a high-stress and unstable environment

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was uniformly resorbed when implanted into the acetabulum in bipolar hip prostheses [51]. Various bench studies have shown what to expect from the initial stability from the impacted graft-prosthetic construct during the initial phase after surgery. It seems possible to achieve acceptable initial stability [52,53], even though morselized grafts have a nonstructural nature [54]. However, the graft must maintain its volume and shape, not only during the initial weight bearing, but also during the entire remodeling period, which involves osteoclastic resorption of the graft and simultaneous osteoblastic new bone formation. High stresses are exerted on the cancellous bone around a femoral prosthesis. In a nite element analysis, the stresses in the cancellous bone next to a primary hip prosthesis were near or above its yield point [55,56]. We do not know how the impacted graft reacts to these fairly high loads and stresses. Some hypothetical scenarios can be discussed. 1. If the graft or part of the graft is revascularized and the new bone apposition by the osteoblasts can compensate for the weakening caused by osteoclastic resorption, equilibrium is achieved. Newly formed trabecular bone, adapted to the stresses during its formation, will ultimately replace the graft. This has been shown to happen in animal studies in the goat and horse, without mechanical weakening during remodeling [57 59]. For this to occur, the graft volume probably must be small and the stresses within certain limits. If at some stage the stresses exceed the yield-stress of the newly forming tissue, it will deform. 2. If the graft, or parts of it, do not revascularize, it will retain its mechanical properties, which we know roughly from bench studies. The stiffness is minimal, consisting mainly of trabecular interlocking and friction between fragments [54]. Creep, which in this case would be a sliding and packing of the bone chips relative to each other, is still possible. Fatigue fractures are not likely to occur, since the graft already consists of fractured bone. 3. If the front of resorption extends further into the graft than the front of bone apposition, just as in osteonecrosis of the hip, the graft will collapse and lose its volume. If this affects a very thin layer of the graft, only a slow distal migration of the prosthesis might occur. If the layer of resorption were thicker, clinical failure would ensue. 4. If the graft is revascularized and invaded by brous tissue surrounding the trabeculae, resorptive activity and new bone formation will be reduced and the mechanical properties preserved, as is thought to happen in some areas of the osteonecrotic hip [60,61]. Even improved resistance to torsional or shear stresses can be expected, due to the

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brous coating of the trabeculae [62], similar to the consolidation phase of fracture healing. During compression, the graft will act as a cushion, like a disc or meniscus distributing stresses over a larger area. In reality, these biological scenarios probably occur in varying proportions throughout the graft. In patients operated on for a fractured vertebral body with morselized and impacted autograft, we found that large volumes of the graft had not remodeled as long as 1.5 years postoperatively, although the fractures were clinically and radiographically healed [63]. Even if some parts of the grafts had remodeled with apparently normal marrow, other parts consisted only of dead graft trabeculae in necrotic avascular tissue. In yet other parts of the graft, the trabeculae showed no signs of remodeling, but were surrounded by revascularized brous tissue. Such incomplete remodeling occurred, despite the use of autologous cancellous bone.

IX.

IS REMODELING NECESSARY?

This incomplete graft incorporation that we found in human vertebrae corresponds to some extent with published histological ndings in series using morselized and impacted grafts in patients after hip revision [59,64 67]. Remodeling increases with time, but scattered areas in various stages of healing are found even after a long time. The composition in space and time of the various healing stages will predict the outcome of the grafting procedure. Since large volumes of graft are used, some parts of it will not revascularize and remodel within a given time. In such parts of the grafts, one might expect that the bone chips would slide relative to each other (creep) and that the graft would lose height in the direction of the load. This probably explains why increased distal migration occurs initially in clinical series compared to primary prostheses. However, in radiostereophotogrammetry (RSA) studies, which are able to detect relative micromotion down to 0.2 mm between the prosthesis and the femur, this initial migration slows down after 1 2 years [68,69] similar to stabile primary prostheses [70,71]. At the time when the migration slows down, the remodeling may have come to an end, just as in large structural allografts or osteonecrosis of the hip, and the proportions of remodeled and unremodeled bone may not change much more. Human histological studies of hip revisions indicate that the graft remodels from the cortex towards the cement [66]. The part near the cement seems to be the least remodeled and often consists of dead graft in brous tissue. But even this unremodeled composite material of necrotic bone and new brous tissue apparently provides adequate load-bearing support for the prosthesis. This compacted unremodeled graft appears as an inert implant

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without causing an immune response [72], with the brous tissue adding to its strength [62]. Total remodeling might even cause the prosthesis to loosen when the remodeling process reaches the bone/cement interface, where it could then form a loosening membrane. One probably should be careful in attempts to enhance or accelerate the remodeling by adding growth factors, since so little is known about their effect on resorption. Speeding up the remodeling might also speed up the resorption, with the risk of mechanical weakening of the construct and reloosening. BMPs are capable, apart from stimulating bone formation [73], of stimulating the osteoclast lineage [45,74]. In a series of hip revisions with morselized impacted allograft supplemented with OP-1, severe bone resorption was encountered in 2 out of 10 cases with concomitant loss of prosthetic position [75]. The secret of the morselized impacted allograft may lie in its being revascularized and remodeled more slowly than structural grafts and the fact that the living bone graft brous tissue composite can provide sufcient support without being totally remodeled. If further development of the method is to be undertaken, methods of decreasing resorption, such as adding bisphosphonates or using nonresorbable hydroxyapatite or titanium beads, should be tried, rather than increasing remodeling with bone-forming proteins.

X.

CONCLUSIONS 1. Endogenous bone proteins play a role in the incorporation of a bone graft. 2. Adding an exogenous growth factor such as OP-1 can increase new bone ingrowth into an impacted graft. 3. An exogenous growth factor such as OP-1 might also increase resorption with deleterious effects. 4. Impaction of a frozen bone graft, regardless of allo- or autogenous origin, delays the ingrowth of host bone into the graft, and not even autografts always become fully remodeled. 5. Mechanical loading of an impacted morselized graft increases graft remodeling. 6. Fibrous ingrowth increases the mechanical strength of an impacted graft.

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Taylor M. Finite element analysis of cancellous bone stresses within an implanted proximal femur and their relationship to implant migration. Thesis, University of London, London, England 1997. Schreurs BW, Huiskes R, Buma P, Slooff TJ. Biomechanical and histological evaluation of a hydroxyapatite-coated titanium femoral stem xed with an intramedullary morsellized bone grafting technique: an animal experiment on goats. Biomaterials 1996; 17:1177 1186. Schimmel JW, Buma P, Versleyen D, Huiskes R, Slooff TJ. Acetabular reconstruction with impacted morselized cancellous allografts in cemented hip arthroplasty: a histological and biomechanical study on the goat. J Arthroplasty 1998; 13:438 448. Buma P, Lamerigts N, Schreurs BW, Gardeniers J, Versleyen D, Slooff TJ. Impacted graft incorporation after cemented acetabular revision. Histological evaluation in 8 patients. Acta Orthop Scand 1996; 67:536 540. Glimcher MJ, Kenzora JE. Nicolas Andry award. The biology of osteonecrosis of the human femoral head and its clinical implications: 1. Tissue biology. Clin Orthop 1979; 138:284 309. Glimcher MJ, Kenzora JE. The biology of osteonecrosis of the human femoral head and its clinical implications: II. The pathological changes in the femoral head as an organ and in the hip joint. Clin Orthop 1979; 139:283 312. Tagil M, Aspenberg P. Fibrous tissue armoring increases the mechanical strength of an impacted bone graft. Acta Orthop Scand 2001; 72(1):78 82. Tagil M, Johnsson R, Stromqvist B, Aspenberg P. Incomplete incorporation of morselized and impacted autologous bone graft: a histological study in 4 intracorporally grafted lumbar fractures. Acta Orthop Scand 1999; 70:555 558. Nelissen RGBT, Weidenhielm LR, LeGolvan DP, Mikhail WE. Revision hip arthroplasty with the use of cement and impaction grafting. Histological analysis of four cases. J Bone Joint Surg 1995; 77A:412 422. Ullmark G, Linder L. Histology of the femur after cancellous impaction grafting using a Charnley prosthesis. Arch Orthop Trauma Surg 1998; 117:170 172. Ullmark G, Obrant KJ. Histology of impacted bone-graft incorporation. J Arthroplasty 2002; 17:150 157. van der Donk S, Buma P, Slooff TJ, Gardeniers JW, Schreurs BW. Incorporation of morselized bone grafts: a study of 24 acetabular biopsy specimens. Clin Orthop 2002; 396:131 141. Ornstein E, Franzen H, Johnsson R, Sandqvist P, Stefansdottir A, Sundberg M. Migration of the acetabular component after revision with impacted morselized allografts. A radiostereometric 2-year follow-up analysis of 21 cases. Acta Orthop Scand 1999; 70:338 342. Karrholm JHP, Carlsson L, Malchau H. Subsidence of a non-polished stem in revisions of the hip using impaction allograft. Evaluation with radiostereometry and dual-energy x-ray absorptiometry. J Bone Joint Surg 1999; 81B:135 142. Karrholm J, Borssen B, Lowenhielm G, Snorrason F. Does early micromotion of femoral stem prostheses matter? 4 7-year stereoradiographic follow-up of 84 cemented prostheses. J Bone Joint Surg 1994; 76B:912 917.

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Tagil and Aspenberg Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg 1995; 77B:377 383. Linder L. Cancellous impaction grafting in the human femur: histological and radiographic observations in 6 autopsy femurs and 8 biopsies. Acta Orthop Scand 2000; 71:543 552. Bostrom MP, Lane JM, Berberian WS, Missri AA, Tomin E, Weiland A, Doty SB, Glaser D, Rosen VM. Immunolocalization and expression of bone morphogenetic proteins 2 and 4 in fracture healing. J Orthop Res 1995; 13:357 367. Kaneko H, Arakawa T, Mano H, et al. Direct stimulation of osteoclastic bone resorption by bone morphogenic protein (BMP-2) and expression of BMP receptors in mature osteoclasts. Bone 2000; 27:479 486. Hostner J, Karrholm J, Hultmark P. Early failures after femoral revisions using milled allograft bone mixed with OP-1. 56th meeting Svensk Ortopedisk Forening, Vaxjo, Sept. 5 8, 2000.

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16
Human Bone Histology After Morselized Cortico-Cancellous Bone Impaction
Gosta Ullmark
Centre for Research and Development Gavle, Sweden

I.

INTRODUCTION

Impaction morselized bone allograft has become the most promising method of restoring living bone lost after loosening of a joint replacement. However, the method of impaction grafting is still in its early phases. Much remains to be learned. In this chapter our current knowledge will be summarized, with emphasis on the bone metabolism during healing of a graft bed as well as on the histological ndings during the healing period.

II.

BIOMECHANICAL ASPECTS

Brewster et al. [1] found that the size of the impacted graft particles should be spread through an optimal mix of sizes represented by a logarithmic curve to obtain the optimal shear strength. The range of chip sizes should, however, be rather large. A mix of not only cancellous chips, but also cortical chips is not a disadvantage as long as the cortical chips are not too big. On the contrary, cortical chips might be advantageous to the strength of the impacted graft bed. Mechanical studies comparing chips from two different milling machines, one with a larger volume range (0.0002 40 mm3) and the other with a smaller range (0.0002 12 mm3) [2], showed that larger chips were more resistant to load.
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Comparing the same two kinds of chips in another study [3], shear strength was higher with the larger chips. Fat removal from bone chips reduces stem migration in an in vitro model [4]. In another in vitro acetabular model, rotational shear strength was greatly increased by fat removal [3]. One of the most important factors in creating a stable graft bed is to use high compaction energy. However, there is a phenomenon of recoil of the graft bed as the impaction phantom is released. This phenomenon will reduce or might even eliminate space for the cement mantle [2]. Particularly when collarless, polished, tapered stems designed to subside within the cement mantle are implanted, the cement mantle must not be too thin [5,6]. Noncontained bone defects, where the cortical shell is absent, have to be converted to contained defects using metal mesh to be able to perform an adequate impaction using the mesh to constrain the graft chips [7]. The vitality of bone graft is best maintained using fresh frozen, unprocessed bone. Defatting of the bone graft is benecial to bone healing [8]. Blood clot instead of marrow in the graft bed improves bone healing [9 11]. Heating the bone graft to 658C barely affects ingrowth, but 1008C severely impairs it [12,13]. In between those temperatures there is gradual reduction of bone healing. Freeze-drying of the bone graft may reduce the bone healing, but good clinical short-term clinical results have been reported [14]. The surgical method must include removal of all the membrane covering the host bone bed. The membrane contains both phagocytosed polyethylene particles and bone-resorbing cells. A cutter should also preferably roughen the host bone surface. The femoral stem has to be of sufcient length to bridge any cortical weakness or perforation by 2 4 cm, or the bone defect can be protected with strut grafts or plates to reduce the risk of periprosthetic fracture [15]. One of the most important factors contributing to a successful result is a well-impacted graft. In the femur this might require a prophylactic wiring of the femur. Any noncontained acetabular defect must be covered with a sufciently stable metal mesh anchored with multiple screws. There might be difculty achieving adequate impaction of the acetabulum with a smooth acetabular impactor. I have found that when the surface of the acetabular impactor has a rough microstructure such as in Figure 1 (Waldemar Link GmbH & Co, Hamburg, Germany), the graft bed can be impacted more rmly.

III.

CLINICAL AND RADIOLOGICAL RESULTS

Acetabular revision using impaction grafting has been in clinical practice longer than femoral and thus has longer follow-up.

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Figure 1 Acetabular impactor designed with micro tracks for a sturdy grip at the bone chips to achieve a stable graft bed.

We reviewed 28 acetabular revision arthroplasties with both cavitary and segmental bone defects (Type III AAOS classication). Impaction grafting was combined with semi-exible (0.5 0.8 mm) titanium mesh (Waldemar Link GmbH & Co, Hamburg, Germany) to cover the cortical defects (Fig. 2) and add stability to the cup. The acetabular impaction was performed using the above mentioned impactors with a rough surface. The polyethylene cups were cemented only onto the impacted graft bed. The results after a median 52 months were good (3.5% mechanical failure and 3.5% septic failure) [7]. Histological results from two of those cases are described later. Using metal rings in the acetabulum as a mechanical augmentation for the cup is meant to add mechanical stability to the impacted graft bed. However, in a literature review (Table 1) metal rings have inferior results because of infection and mechanical loosening. Metal rings may prevent loading of the graft bed, which is a disadvantage because dynamic load promotes bone healing [16]. Impaction grafting of acetabula with noncontained defects is better when semiexible metal mesh is used instead of larger metal rings, but thin wire mesh might be inadequate [17].

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Figure 2 Acetabular rim mesh from 0.8 mm pure titanium for converting a segmental, non-contained acetabular bone defect to a contained defect before impaction grafting.

The clinical and radiological midterm results after impaction grafting in the femur are good. The problems reported include subsidence of the stem using polished collarless stems and postoperative femoral fractures related to short stems. Another issue of concern is the variety of the results (Table 2). Impaction grafting in the femur is performed in a wide variety of ways by many surgeons in various centers. Those variations are; the diagnosis, the sizes of the bone chips, processing of the chips, cleaning and preparation of the host bone bed, hardness of the impaction, thickness of the cement mantle, blood clot containment of the graft bed, length of the stem, and postoperative migration of implant and cement mantle. The wide variety of clinical results from a literature review (Table 2) is probably the result of the abovementioned variation in surgical technique. There is an interesting debate about the merits of combining impaction grafting with a polished collarless stem or with a matte stem, with or without a collar. According to the literature review in Table 2, there seems to be less mechanical loosening in the collared matte stems. However, this debate remains to be resolved scientically.

Table 1 Findings in Clinical Studies of Impaction Allografting in the Acetabulum at THA No. of acetabular reconstr. Mean duration of follow-up (yr) Percent mechanical loosening Percent septical failure

Histology After Bone Impaction

64 66 28 42 42 63

4.6 5 2.8 5 10 5.5

10 8 0 12 2 5

12 0 0 12 7 3

Metal rings, morselized bone graft and a cemented cup Udomkiat et al. [18] Rosson et al. [19]a Peters et al. [20] Berry et al. [21] Van der Linde et al. [22] Perka et al. [23] Morselized bone graft and a cementless cup Hubble et al. [24] Morselized bone graft and a cemented cup Azuma et al. [25] Bolder et al. [26]b Schreurs et al. [27]c Olivier et al. [28] Slooff et al. [29] Ullmark et al. [7]d Boldt et al. [17] 68 5 9 24 27 34 46 88 28 173 5.8 7.6 13 2.7 5 4.4 4 0 4 6 2 10 4 3

0 0 0 2 1 4 2

3/4 of the cases had morselized bone graft, of which one half had autograft and the other half allograft. Half of the cases were revisions. Primary THA for congenital hip dysplasia using autologous graft. c 23 primary THA and 18 revision THA. d Combined cavitary and segmented defects (Type III AAOS classication).

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Table 2 Mean duration of follow-up (mos) Percent subsidence 79 48 23 44 20 81 86 50 11 7 5 10 6 14 19 0 3 3 84 31 13 30 60 60 84 31 43 Percent mechanical looseninga

Findings in Clinical Studies of Impaction Allografting in the Femur at THA

Study 44 67 79 34 35 21 43 30 74

No. of THA

Polished stems without a collar Ling et al. [30] Exeter Elting et al. [31] CPT Eldridge et al. [32] Exeter, CPT Meding et al. [33] CPT Masterson et al. [6] Exeter Van Biezen et al. [34] Exeter Mikhail et al. [35] CPT Knight et al. [36] CPT Lind et al. [37] Exeter Collared stems with a roughened surface Nivbrant et al. [38] Lubinus Karrholm et al. [39] Spectron Ullmark et al. [40] Lubinus Ullmark et al. [40] Charnley Leopold et al. [41] Harris Boldt et al. [17] Charnley Collared stems, polished or matte Fetzer et al. [42]c 12 22 23 26 29 79 20 58 30 64 64 63 48 72 0b 0b 14 8 8 9 5

0 0 4 4 12 5 0 Ullmark

Loosening dened according to Harris and McGunn [43]. 0.30.4 mm mean in a RSA study. c Iowa stems, Triumph stems, Heritage stems and Harris Precoat stems.

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231

IV.

HEALING OF THE GRAFT BED STUDIED WITH PET

Positron emission tomography (PET) is a nuclear medical modality used to quantify chemical processes in vivo. PET is found to be a sensitive method to detect metabolic events like angiogenesis and bone healing in a bone graft bed. In a study of ve patients having a revision THA, including impaction grafting and a cemented matte stem with a collar, 170 mm long (Lubinus SP-II, Waldemar Link GmbH & Co, Hamburg, Germany), revision THA was performed for loosening and osteolysis (bone loss grade IIIV Endo Klinik Classication) of a primary hip arthroplasty [50]. Plain radiographs showed stable stems in all patients. The clinical results were good in all patients 3 years after surgery. [15O]-water PET was used to quantify bone blood ow and [15O]-carbon monoxide to determine blood volume in the allograft surrounding the femur stem. Kinetic [18F]-uoride PET was used to produce quantitative images of new bone formation in the graft beds. All patients were asssessed at two different times: 18 days and 12 months after surgery. Three patients were also studied 4 months after surgery. Even 8 days after surgery there was highly increased blood ow and bone formation adjacent to allograft (60% and 400%, respectively). After 4 months the highest activity was seen within the graft material (Fig. 3). One year after surgery bone blood ow had declined to the levels of the contralateral femoral shaft in

Figure 3 Density, blood ow ([15O]-water), and bone formation rate ([18F]uoride) PET in a patient 4 months after surgery.

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most of the graft bed. On radial prole analyses of bone healing inside the femur, the maximum bone-forming activity at one week after surgery was found to be at a distance of 22 mm (which is the interface between cortex and the graft bed). One year after surgery this maximum bone-forming activity had advanced and was 13 mm apart, which is adjacent to the cement mantle (Fig. 4). These analyses using the sensitive PET technique provided evidence that angiogenesis and new bone formation occurred early following impaction grafting in the femur.

V.

HISTOLOGY OF IMPACTED BONE GRAFT INCORPORATION

Whether impacted bone chips heal to living bone, have brous tissue ingrowth around dead graft particles, or even remain dead as a lling material can now be

Figure 4 Peak to peak distance of transverse sections using 18uoride PET in a patient 1 week and 1 year after surgery.

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233

determined. We evaluated the histological ndings of 34 tissue samples from 22 cases in 20 different patients (Table 3). The samples were taken 1 48 months after revision arthroplasty and impaction grafting in the hip (Lubinus SP-II prosthesis or Charnley Elite Plus prosthesis) and the knee (Link Rotation Knee) [44,45]. The histological ndings one month after surgery were that a brous stroma and some newly formed woven bone were found in the graft beds (Fig. 5). Four months after surgery, the brous stroma had advanced in the graft bed. Many of the dead trabeculae in the graft beds had layers of living bone and

Table 3 Histologically Evaluated Bone Grafts in 22 Cases in 20 Patients (20 Hips and 2 Knees) Histology, months p.o. 1 1 3 4 4 4 4 6 6 6 7 7 8 8 8 8 9 11 14 6 23 48 X-ray Subsid. Mm 0 0 0 0 0 0 0 4 0 0 3 3 0 0 0 0 6 0 0 0 0 0 Trab. Yes Yes Yes Yes No Yes Yes No Yes Yes No No Yes Yes Yes Yes No Yes No No Yes Bone def. III II III III II II II II II III II II II II II II III II 3 III 3 III

Pat No. 1h 2h 3h 4h 5h 6h 7h 8h 9h 10 h 11 h 12 h 13 h 14 h 15 h 16 h 17 h 18 h 19 k 20 h 1k 2h

Gender F M M M F F F M M F M M F F F M M F M F F M

Age 71 77 74 65 66 78 75 74 66 68 62 68 76 74 87 69 62 74 63 81 71 77

Prosth. Lub Ch Lub Lub Lub Ch Ch Lub Lub Lub Ch Ch Ch Ch Ch Lub Lub Lub Rot knee Ch Rot knee Ch

Subsid; mean subsidence of the matt stem inside the femur during the rst months after surgery, visible on plain radiographs. Trab; mean new trabeculae formation visible on plain radiographs somewhere in the transplanted area two to four years after surgery. Bone def; mean preoperative bone defects classied according to the Endo Klinik classication for the hip and according to Engh for the knee.

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Figure 5 One month postoperatively. Remnants of brin clot and granulocytes together with some brous stroma. Dead trabeculae from bone graft (G) together with a layer of living bone (B). (Hematoxylin eosin 280)

osteoid in all samples (Fig. 6). Fluorochrome revealed some bone-forming activity in the 3 mm layer inside cortex. Six to 7 months after surgery, the healing had advanced close to the cement layer in terms of more abundant amount of osteoid also in those areas. The uorochrome revealed bone-forming activity. Six months after surgery in one postmortem femoral specimen, most transplanted areas were revascularized. In the proximal femur there was new bone formation peripherally, but with a substantial amount of brous stroma embedding graft pieces closer to the cement. In the diaphysis new bone formation had proceeded to within less than 0.5 mm of the cement. Eight to 11 months after surgery, the 3 mm layer at the inside of the cortical bone showed less brous tissue and more normal fatty marrow compared to earlier biopsies. The layer of living bone surrounding the necrotic graft particles was enlarged compared to earlier biopsies (Fig. 7). The innermost layer of the biopsies close to the cement showed a mixture of necrotic graft surrounded by brous tissue. The amount of osteoid had increased in this central part. The uorochrome revealed bone-forming activity. Forty-eight months postoperatively in one postmortem femoral specimen, all areas of former graft bed were transformed into living bone (Fig. 8) except for

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235

Figure 6 Three to 4 months postoperatively. New bone (B) and osteoid formation (arrow) on necrotic bone graft (G). (Goldner, 140)

the proximal section. In this area a composite of living bone and areas of dead trabeculae surrounded by a layer of living bone and brous tissue was seen all the way into the cement layer (Fig. 9).

VI.

DISCUSSION

We found rapid-onset bone healing onto an impacted graft bed consisting of hard impacted, fresh frozen, morselized, and fat-reduced homologous bone. Blood ow was increased in the soft tissue adjacent to a graft impacted femur one day after surgery. Eight days after surgery, bone healing had started in the interface between endosteum and graft bed. Three to 4 weeks after surgery, a very cellular brous tissue together with capillaries were replacing the blood clot surrounding the bone chips. At this time osteoid and woven bone had started forming on some of the graft chips. Six months after surgery, the bone-forming activity had taken place throughout most of the graft bed, even in close contact to the cement mantle. One year after surgery, the maximum bone-healing activity had advanced throughout the graft bed and was now in close contact to the cement mantle. Four years after

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Figure 7 Nine months postoperatively. A thick layer of new bone (B) and osteoid (arrows) on a minor piece of necrotic bone graft (G). (Goldner, 280)

Figure 8 Forty-eight months postoperatively. Cortex (C) continuous transition into new living bone trabeculae (B). Hematopoietic marrow (HM). Dissolved cement layer (DC). (Goldner, 40)

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Figure 9 Same patient as in Figure 8. A mixture of living new bone (B), and necrotic bone graft (G) embedded partly in a brous stroma (F) and partly in desolved cement (DC).

surgery, most of the former graft mantle surrounding a femoral stem consisted of living bone with trabecula arranged in the direction of load. Residual necrotic graft particles were most likely to be found in the proximal end of the former graft bed surrounding a femoral stem. Any area where the cortical shell was absent at the time of revision but was covered by a sturdy tting metal mesh had normal healing. Less successful healing occurs and has been described in the literature [46 48]. At present we do not really know the critical variables that inuence graft healing. The method of lling bone defects in the acetabulum by morselized bone graft using reversed reaming can hardly be characterized as impaction, merely a lling of the defects probably producing inferior biomechanical characteristics. Dynamic loading of the graft bed stimulates healing, as does blood clot in between the necrotic trabecula of the graft bed. A personal reection is that the diagnosis pelvospondylitis ossicans (or the related drugs) might be a disadvantage in terms of bone healing and clinical success for impaction grafting. We are optimistic about the present and the future prospects of reconstructing missing bone using impaction grafting, cemented prostheses, and metal mesh.

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1. Brewster NT, Madabhushi SPG, Usmani A, Gillespie WJ, Fairburn N, Howie CR. The fragment size of morcellized bone from frozen and thawed bone compared to a mechanical ideal. SICOT 7th World Congress, Amsterdam, The Netherlands, August 16 19, 1996. Ullmark G, Nilsson O. Impacted cortico cancellous allografts: recoil and strength. J Arthroplasty 1996; 14:1019 1023. Ullmark G. Bigger size and defatting of bone chips will increase cup stability. Arch Orthop Trauma Surg 2000; 120:445 447. Hostner J, Hultmark P, Karrholm J, Malchau H, Tveit M. Impaction technique and graft treatment in revisions of the femoral component. J Arthroplasty 2001; 16:76 82. Masterson EL, Bassam AM, Duncan CP, Rosenberg A, Cabanela M, Gross M. The cement mantle in femoral impaction allografting. J Bone Joint Surg 1997; 79B:908 913. Masterson EL, Masri BA, Duncan C. The cement mantle in the Exeter impaction allografting technique. A cause for concern. J Arthroplasty 1997; 12:759 764. Ullmark G. Morcelised impacted cortico cancellous bone allografts in revision surgery for endoprosthetic loosening with osteolysis, experimental and clinical studies. Thesis, University of Uppsala, Uppsala, Sweden, 2001. Thoren K. Lipid-extracted bone graft. Thesis, University of Lund, Lund, Sweden, 1994. Centrella M, McCarthy TL, Canalis E. Effects of transforming growth factors on bone cells. Conn Tiss Res 1989; 20:267 275. Buma P, van der Donk S, Schreurs BW, Gardeniers JWH, Slooff TJJH. Histological studies of human biopsies of impaction grafting in the acetabulum. 33th Congress of Polish Orthopaedics and Trauma Society, Krakow, Poland, Sept. 21 23, 2000. Grundnes O, Reikeras O. The importance of the hematoma for fracture healing in rats. Acta Orthop Scand 1993; 64:340 342. Kuhne JH, Bartl R, Hammer C, Retior HJ, Jansson V, Zimmer M. Moderate heat treatment of bone allografts. Arch Orthop Trauma Surg 1992; 112:18 22. Shimizu K, Masumi S, Yano H, Fukunaga T, Ikebe S, Shin S. Revascularization and new bone formation in heat-treated bone grafts. Arch Orthop Trauma Surg: 1999; 119:57 61. de Roeck NJ, Drabu KJ. Impaction bone grafting using freeze-dried allograft in revision hip arthroplasty. J Arthroplasty 2001; 16:201 206. Pekkarinen J, Alho A, Lepisto J, Ylinen P, Ylikoski M, Paavilainen T. Impaction bone grafting in revision hip surgery. J Bone Joint Surg 2000; 82B:103 107. Wang JS, Tagil M, Aspenberg P. Load-bearing increases new bone formation in impacted and morselized allografts. Clin Orthop 2000; 373:274281. Boldt JG, Dilawari P, Agarwal S, Drabu KJ. Revision total hip arthroplasty using impaction bone grafting with cemented nonpolished stems and Charnley cups. J Arthroplasty 2001; 16:943 952.

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17
Histological Evaluation of Impaction Bone Grafting in Humans and Animals
Pieter Buma, Sanne van der Donk, and B. Willem Schreurs
University Medical Centre Nijmegen Nijmegen, The Netherlands

I.

INTRODUCTION

Most total hip arthroplasties, both cemented and cementless, fail due to aseptic loosening, a slow but progressive process often resulting in bone stock loss. The stability of the implant becomes compromised, and the components start to migrate in the bone bed. The key problems in revision surgery are how to manage the periprosthetic bone loss and how to create a new long lasting stable hip replacement. Bone impaction grafting with a cemented cup is clinically a well proven technique. The technique is supported by data from various animal models, which show that the impacted fresh frozen allograft bone completely incorporates into a new bony structure [3,4]. However, histological studies of human retrievals have shown areas that are not incorporated [5,6]. The studies involved were series and did not quantify the different tissues described. In the rst part of this chapter we describe the process of bone graft incorporation qualitatively and quantitatively in a large series of biopsies of acetabular impaction graftings in humans. In the second part of this chapter we describe the effect of rinsing on the incorporation of impacted bone graft in an animal model. Rinsing of allograft bone prior to impaction is used by some groups, and it may reduce the immunological response to the allograft [7 9]. Therefore, we hypothesize that a simple processing step like rinsing of allograft
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bone might improve the incorporation of allograft bone. We studied this in a bone chamber model [10,11]. On the other hand, impaction of bone graft will also expose growth factors in the bone matrix that have the potential to enhance incorporation of the bone graft. It has been shown that after impaction TGF-b is released from the impacted bone [12]. This indicates that by rinsing after impaction, which is performed by some clinicians to improve the cement penetration and clean the bone bed, growth factors that are exposed by the impaction process are washed away. Therefore, we performed a second rinsing experiment in which we rinsed the bone graft after the rst impaction and then impacted again.

II. A.

MATERIAL AND METHODS Acetabular Patient Biopsies

Twenty-four biopsies of 20 patients, which were collected during a period of 15 years, were processed for histology. Biopsies were obtained after 5 impaction graftings in primary THA and 19 reconstructions in revisions. The mean followup period was 48 months (3 170 months). In 3 of the 5 primary cases autograft from the femoral head was used. In 2 primary cases autograft was combined with femoral head allografts. Fresh frozen femoral head allografts were used in all revision cases. All were obtained from the local bone bank and morselized during surgery into chips of about 12 1 cm3. This was done by hand with a rongeur in 76% of the cases. In 19% a specially designed bone mill was used to make the chips (Novio Magnus bone mill, developed by Spierings, Nijmegen, the Netherlands) and in 5% a combination of both techniques was used. The number of femoral heads used varied from one to three, depending on the severity of the acetabular defect. Defects were classied as cavitary (10 cases), or a combination of both cavitary and segmental defects (11 cases), according to the American Academy of Orthopedic Surgeons (AAOS) classication system [13]. In all patients the surgical technique was performed as described previously [14 16]. Biopsies were taken during revision operations, which were performed for dislocation (6 cases), septic loosening (7 cases), aseptic loosening of the cup (7 cases), aseptic loosening of stem (1 case), sciatic nerve problems (2 biopsies from one patient), or femoral fracture (1 case). B. Histological Analysis

In the histological sections we determined the surface area of incorporated bone graft (new bone structure), nonincorporated bone graft remnants, areas of brous tissue without bone graft, and a tissue type with active incorporating bone graft [17]. We also recorded cartilage remnants in the nonincorporated bone graft.

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C.

Rinsing Study: Preparation of Materials

An animal study was performed in the goat using the bone conduction chamber (BCC), developed by the group of Aspenberg (Fig. 1) [10,11,18]. Trabecular autograft was obtained from the distal femur during the same operation as the implantation of the bone chambers. Trabecular allograft was obtained from the sternum of donor goats. Donor and recipient goats were not related. A pool of all the bone was made to avoid large differences in individual immunological reactions, and thereafter the bone was stored at 2808C until use. Before impaction the grafts were nibbled with a rongeur to a chip size of approximately 2 2 1 mm and rinsed and impacted according to the protocol (Table 1). The chambers were lled with either auto- or allograft. Three different treatment protocols were applied to each type of bone graft. In the rst group the grafts were impacted without any further preparation and acted as controls. In the second group the grafts were washed prior to impaction with high-pressure saline. The lavage was standardized for pressure, temperature (378C), and volume. During the washing the red graft particles acquired a white appearence, indicating that all blood and marrow tissue was removed successfully. In the third group, the lavage was repeated to wash out additional growth factors exposed after the rst impaction; thus, grafts were washed, impacted, washed, and impacted again before

Figure 1 Bone conduction chamber. The bone conduction chamber consists of two half-cylinders (C) held together by a screwcap (S). A disc (D) is used to lower the two ingrowth openings (I) just below the tibial cortex (T). New bone and tissue ingrowth (N) into the graft (G) is now possible via the marrow (M). [10]

244 Table 1 Experimental Protocola Autograft 10 10 10 Allograft 10 10 10

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Graft treatment Impaction only Rinsing and impaction Rinsing, impaction, rinsing and impaction
a

N 10 goats for each graft treatment for each graft type. Source: Ref. [36].

insertion in the bone chamber. New bone and total tissue ingrowth were measured as indicators of potential for incorporation [17]. After impaction for 2 minutes with a static pressure of 25 Mpa in a specially designed instrument (Fig. 2), a graft cylinder (2 mm diameter) was obtained, which t exactly in the BCC. Ten mature Dutch milk goats (Capra Hircus Sana) weighing about 55 kg (range 41 69 kg) received three BCCs at each side in the cortical bone of the proximal medial tibia for a period of 6 weeks. Insertion of the bone chambers is described elsewhere in detail [18]. On both legs the BCCs were placed at a distance of 10 mm from each other (Fig. 3). Within one animal, all BCCs with allograft were placed on one side and all BCCs with autograft on the other to prevent the grafts from inuencing each other. The position of implantation among the three chambers was randomized, as was the side for each type of graft. All animals were allowed unrestricted movement in their cages and had free access to water and food after the operation.

Figure 2 Impaction device. Morselized bone grafts are inserted into a cylinder. A piston (P) is inserted into this cylinder to impact the morselized bone graft with 25 MPa for 2 minutes. After impaction the bottom (B) is screwed off to remove the graft out of the cylinder. (From Ref. [36].)

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Figure 3 Radiographs of bone conduction chambers in the proximal medial tibia of the goat. (Left) anteromedial view; (right) anterolateral view. (From Ref. [36].)

After 6 weeks the goats were killed, tibiae removed, and the contents of the chamber were processed for serial sectioning. Areas of new bone formation, graft remnants, and total tissue ingrowth were scored. The area of bone ingrowth included marrow cavities, new bone formation, and new bone formed on graft remnants [18]. Bone ingrowth and total tissue ingrowth values of the three sections per bone chamber specimen were used for statistical analysis. The effects of graft type and graft treatment on the ingrowth distances were analyzed with a threeway analysis of variance (ANOVA) for the factors goat, graft type, and graft treatment. Tukeys test was used for post hoc multiple comparison to identify signicant differences among the treatment groups. All analyses were performed with SPSS (Chicago, IL).

III. A. 1.

RESULTS Human Acetabular Biopsies Short-Term (0 6 Months)

Particularly in the biopsies taken at 3, 4, and 5 months after impaction grafting, the transitions between the dead graft of the reconstruction (bone particles with empty osteocyte lacunae embedded in necrotic brin deposits), the revascularization front, and the newly incorporated bone graft were present (Fig. 4A). During the revascularization of the graft, osteoclastic activity was high. New woven bone

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Figure 4 Histology of human biopsy specimens. (A) A human core biopsy with a short-term follow-up, showing the presence of different stages in one biopsy. Note the dead grafts (top), brous tissue (middle), and active bone remodeling (bottom), stain HE, magnication 20. (B) New bone (nb) is formed on a cellular graft remnants (gr), stain HE, magnication 120. (C) New woven bone is formed in interstitial brous tissue, stain HE, magnication 70. (D) Bone is apposited on graft remnants (arrow heads), surrounded by brous marrow. Note the active mineralizing bone surface (arrows), stain Goldner, magnication 35. (E) Areas of necrotic marrow (nm) are present in the spaces between the avital trabecular bone structure (ab), stain HE, magnication 170. (F) A dark precipitate (arrow heads) surrounds no incorporated graft remnants (gr), stain HE, magnication 90. (G) A thick layer of brous tissue (ft) is formed directly under the mesh (mesh removed for histotechnical reasons), but direct bone contact also is present (arrows), stain HE, magnication 45. (H) Fibrocartilage has formed near a no incorporated graft remnant at the interface of cement with graft, stain Goldner, magnication 190. (I) Large pieces of cartilage (c) showed no incorporation, stain HE, magnication 30. (From Ref. [36].)

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formation was found directly on the graft remnants (Fig. 4B) and in the interstitial brous tissue (Fig. 4C). Fibrin remnants were also covered by new woven bone. Locally, dense areas of lymphocytes were present in the brous tissue and in the medullary tissue of the newly formed trabecular bone. The semi-quantitative results clearly showed that in the rst 6 months about 30% of the graft was incorporated (Fig. 5). 2. Mid-Term (7 Months 9 Years)

In all specimens taken 8 30 months after revision, the amount of nonincorporated graft had diminished. Graft remnants within the newly formed trabecular bone were extremely rare. The amount of woven bone was clearly less than in the earlier biopsies, and more lamellar bone was found. Initially the medullary tissue in the woven bone was brous, but concomitant with the remodeling of the woven bone into normal lamellar bone, vital, cell-rich medullary tissue with many fat cells predominated (Fig. 4D). Areas with dense trabecular or almost cortical bone were also seen. 3. Long-Term (!10 Years)

In general, the bone graft was almost completely incorporated into new bone with normal medullary tissue. Occasionally, the medullary tissue of the bone showed accumulation of macrophages that had deeply penetrated into the bone. Larger

Figure 5 Distribution of the three different stages during the incorporation process. Short-term: 0 6 months; mid-term: 7 months 9 years; long-term: 10 years or longer. Stage 1: nonvascularized graft remnants. Stage 2: active incorporating bone graft with revascularization. Stage 3: newly formed trabecular bone. Loose brous tissue was scored separately. (From Ref. [36].)

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areas of the medullary tissue of trabecular bone with a normal morphology were completely necrotic, which was particularly seen in the biopsies taken after aseptic loosening (Fig. 4E). On the necrotic trabeculae and in the necrotic medullary tissue, a precipitate was seen, which stained positively with the hematoxylin (Fig. 4E). 4. Interface

In a few biopsies the graft/cement interface was still present. Case 7 was the only case in which the interface with the cement layer was not aseptically loosened. Locally living bone was found in direct contact with the cement, but at most locations a thin soft tissue layer interfaced with the cement. In two biopsies taken at 22 and 72 months, no intact interface was present due to the loosening process, but there was only living bone without graft remnants. The interface with the cement layer had, if present, the normal characteristics of interface tissue as in primary aseptic loosened cups. Focal necrotic areas were found, alternating with areas that contained macrophages with various wear particles. A thick layer of brous tissue had formed directly under the mesh (Fig. 4G). 5. Fibro-Cartilage

In a number of biopsies bro-cartilaginous tissue was present (Fig. 4H). In one case it had formed on the bony side of the mesh that was used to contain the graft. Particularly in cases of aseptic loosening, brocartilage was present at the interface of the incorporated graft with the soft tissue interface with the cement layer. 6. Cartilage

All biopsies in which the graft had been processed by a bone mill contained large fragments of necrotic donor cartilage (Fig. 4I). In contrast, only one of the manually processed grafts contained cartilage remnants. The large fragments were not calcied and appeared as red in the Goldner staining. The smaller fragments were only slightly calcied on the edges. Since no osteoclastic activity was found that had resorbed the cartilage fragments, the pieces were generally not incorporated into a new trabecular structure. In some cases a thin brous capsule surrounded the fragments. 7. Nonincorporated Graft

Irrespective of the follow-up period of the specimens, in some areas of variable sizes, localized nonincorporated bone graft was found (Fig. 4F). In these areas, brous tissue surrounded the acellular bone graft. In contrast to the relatively high percentage of incorporation seen in the other biopsies at mid-term, two

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biopsies of 59 and 79 months postoperatively showed large areas with graft remnants of 40% and more. Both graftings were failures: one aseptic (59 months) and one septic loosening (79 months). 8. Infection

Almost all biopsies from patients with an infection had a follow-up of less than 30 months. Only one infection was diagnosed after 79 months. Most of these infected cases showed complete and normal graft incorporation, with either normal or brotic medullary tissue. Accumulations of polymorphonuclear granulocytes were present in the marrow in between the incorporated bone graft. B. Bone Chamber Study

All 60 implants except 2 in the allograft group were well xed after 6 weeks. In all cases new bone or brous tissue, irrespective of the contents of the chamber, covered the bone chambers. No new bone formation was seen at the endosteal surface of the tibial cortex. 1. Histological Analysis

In the chambers new bone was growing by intramembranous ossication, upwards from the ingrowth openings to the top of the chamber. The new bone was separated from the original inserted graft material in the top of the chamber by a layer of well-vascularized brous tissue (Fig. 6A), which preceded the bone ingrowth front. The brous tissue was more loosely organized at the transition with the graft remnants. In this area, osteoclasts were actively resorbing the graft (Fig. 6B). More chambers lled with autograft showed new bone formation (28 of 30 chambers) as compared to the BCCs with allograft (23 of 28 chambers). The amount and appearance of the new bone varied between specimens from young, woven bone, surrounded by active osteoblasts, to more mature lamellar bone with fatty marrow and trabeculae (Fig. 6C,D). Active osteoblasts and osteoid were still seen after 12 weeks (Fig. 6E). Particularly in the BCCs with autograft, more graft remnants were incorporated into the new bone (in 13 of 30 autograft specimens and 3 of 28 allograft specimens). 2. Histomorphometry

The estimated means (with 95% condence intervals) of bone and total tissue ingrowth are shown in Figure 7. Allografts, as a group, had less bone and total tissue ingrowth than autografts (p , 0.001 and p 0.001, respectively). Washing affected total tissue ingrowth (p , 0.001), which was higher in grafts

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Figure 6 Histology on hematoxylin and eosin (A D) and Goldner (E) stained sections (gure at the end). (A) Graft remnants (gr) were still present in the top of most specimens. They were invaded by brous tissue (ft). New bone formation (nb) took place from the ingrowth openings (arrows) up to the top of the chamber, with an irregular ingrowth front (10). (B) Graft remnants, surrounded by loosely organized brous tissue, are resorbed by active osteoclasts (arrows) (165). (C) Mature lamellar bone trabeculae within fatty marrow could be found at the bottom of the bone chamber (40). (D) New bone formation often was adjacent to blood vessels along the longitudinal axis of the chamber (85). (E) Osteoblasts are appositing new bone (arrows). Osteoid is colored black (85). [18]

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Figure 7 Histomorphometric results. Estimated means for bone ingrowth (A) and total tissue ingrowth (B) with 95% condence intervals. Grafts were treated according to the protocol; impacted grafts; rinsed, and impacted grafts; and rinsed, impacted, rinsed, and impacted grafts [From van der Donk et al., CORR, in press].

washed once than in unwashed grafts ( p , 0.001). The effect of washing on bone and total tissue ingrowth was different in autografts and allografts, because of the interaction of graft type and treatment (p 0.035 and p , 0.001 for bone and total tissue ingrowth, respectively). Bone ingrowth increased after rinsing once in allografts, but decreased in autografts. The increase in total tissue ingrowth after rinsing once was more pronounced in allografts than autografts. After washing once before impaction and twice before and after impaction, there was signicantly greater bone ingrowth in autografts compared to allografts (p 0.02). Graft type and rinsing interacted. There was less total tissue ingrowth in autografts washed twice than those washed once (p , 0.01).

IV. A.

DISCUSSION Acetabular Biopsies

Although biopsies, apart from postmortem retrievals of impaction graftings, are the only way to study the incorporation process, they have one serious disadvantage. The main disadvantage is that biopsies are only taken during reoperations and the histology of the (incorporated) graft is in many cases compromised by the failure process, which will adversely affect the outcome. Therefore, we believe that the proportion of new healthy bone in long-term functioning impaction graftings is higher than found in this study. So far, the few reports on the histology of bone graft incorporation in the acetabulum or femur after impaction grafting are descriptions of retrieval material or describe a relatively small number of biopsies or retrievals

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[5,6,19,20]. Incorporation was seen in most of these biopsies and retrievals, but the small number of specimens studied failed to quantify the completeness of the incorporation. In our series we could do this, and it appeared that incorporation of the impacted graft in the acetabulum was, as in previous animal studies [3,21 23], a mixed process of osteoconduction on the remnants of the graft and osteoinduction. In the latter process woven bone is produced rst and later remodeled into lamellar bone. The main difference with animals is that it seems that the incorporation process in humans is slower and less complete even after very long follow-up. More than one factor could be responsible for this observation. The patients involved in this study are relatively older than animals. The animal bone had not been subjected to the insult of a failed joint replacement. We can only speculate why these nonincorporated areas remain. The size of the graft, the location within it, the local loading conditions, and important patient variables such as the vascularity of the host bone bed, the immune response, the level of activity, and the age of the patients may all play a role. Based on the histology, brin seems to be a powerful stimulator of bone formation in the early phase of bone graft incorporation. The role of brin may be explained by its content in bone active growth factors. This suggests that extensive lavage of the graft after impaction should be avoided to retain active bone-inducing factors. The fact that cartilage fragments were found in the more recent biopsies of grafts from milled bone suggests that all cartilage should be removed before impaction. Only one biopsy, in graft that had been prepared manually, showed large pieces of cartilage, probably included during the process of cutting the graft into smaller pieces. When using a bone mill, instead of manually preparing graft, one should therefore be extremely careful to exclude all cartilage remnants. B. Bone Chamber Study

The results of the study in the BCCs showed that washing allograft improved its incorporation. Particularly in allograft, new bone formation was found directly on graft remnants. Although in general the immunogenicity of bone allograft is low [24], the soft tissues are responsible for this response [9,25]. Other techniques to reduce the immunogenicity of allograft bone include freezing [26], lyophylization [27], fat removal by chloroform or ethanol [28] but are less effective [26], reduce the mechanical strength of bone [27], or may have toxic side effects [28]. An additional advantage of washing out fat with saline is improved strength and initial mechanical stability [2,29]. However, these studies were done with small bone graft sizes (3 5 mm), and similar experiments with large bone graft in an articial acetabulum model [30] showed a signicant effect on the initial mechanical stability of rinsing of the graft in a realistic acetabular model. The

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observation that in autografts and washed allograft bone more of the original bone graft is incorporated into a new bone structure supports the idea that the immunological reaction induces osteoclast activity during incorporation of the graft. Not only the bone ingrowth, but also the total tissue ingrowth was higher in autografts than in allografts. Removal of blood, marrow, and fat improved the ingrowth of allografts. The benecial effect of fat removal on graft incorporation was earlier reported in bone chamber study in rabbits, although cancellous bone allografts were used instead of impacted morselized cancellous bone grafts [31]. The second hypothesis was that washing the graft after impaction would remove the effect of exposed growth factors, resulting in less bone formation compared to grafts not washed after impaction. Bone-derived growth factors may be exposed or released by impaction and provide sufcient biological activity to stimulate new bone formation [12]. These biologically active factors accelerated bone healing in numerous animal as well as human studies when applied exogenously [32 35]. However, in our study, there was no signicant reduction in bone formation in grafts washed after impaction. The static compaction applied in this study might not have freed large quantities of growth factors. Equally, the effects of small quantities of biologically active factors might have been either too small or obscured by other growth factors produced in the soft tissue after insertion of the bone graft, as occurs in fracture healing. In summary, we can state that bone graft incorporation is never complete. Washing bone grafts may promote quicker and more complete incorporation. The effect of washing after impaction has no serious biological implications, but the effect on cement penetration and initial stability is being currently investigated.

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18
Biological Enhancement of Bone Graft Materials by Osteogenic Factors
Stephen D. Cook and Robert L. Barrack
Tulane University School of Medicine New Orleans, Louisiana, U.S.A.

I.

INTRODUCTION

The number and complexity of total hip arthroplasty cases continues to increase. The challenges of complex hip arthroplasty include bone loss in the proximal femur and acetabulum as well as deformity, cortex perforation, and periprosthetic fracture. The use of bone graft material has become routine in many of these cases [1 3]. The added surgical time, limited supply, and morbidity associated with the autogenous bone graft harvest has resulted in the use of various types of allograft bone in the vast majority of cases. Contained defects are effectively managed with morselized cancellous allograft. While allograft bone can heal defects, ingrowth does not occur from the defect to a porous ingrowth surface. This can compromise component stability if extensive defects are present. In addition, when there is a need for immediate structural support, cortical allografts are often used, which have a much slower rate of incorporation. Allograft bone is an attractive alternative to autograft bone because it supports bone formation, supply is less limited, and large structural restorations are possible. However, allograft bone has only a fraction of the osteoinductive capacity of autograft bone [4] and a lowered capacity to incorporate with host bone [5 7]. Cortical allografts have the added disadvantage of slower incorporation and a higher rate of nonunion compared to cancellous allograft
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[8,9]. Nonetheless, cortical strut grafts are widely utilized in conjunction with hip arthroplasty when biomechanical support is required. Allograft also carries a small risk of disease transmission and requires extensive testing of donors. Some methods of sterilization such as high-dose radiation and freeze-drying compromises the mechanical properties of allograft bone. Recent research has centered on the use of osteoinductive materials such as osteogenic proteins (OPs) or bone morphogenetic proteins (BMPs) to aid in the healing of bone. These proteins, either alone or in combination with other regulatory molecules, induce new bone formation [10 16]. Osteogenic proteins are members of the transforming growth factor-b (TGF-b) superfamily of proteins involved in the cascade of cellular events of tissue formation and regeneration, including stem cell commitment, differentiation, and proliferation [12]. Osteogenic proteins have been produced in highly puried form from the bones of a variety of species and have been found to induce bone formation at ectopic and orthotopic sites in small and large mammals [12,17 19]. The most recent advance in the development of OPs is the cloning and expression of recombinant human bone proteins. Recombinant human osteogenic protein-1, also referred to as bone morphogenetic protein-7 (rhOP-1, rhBMP-7) and bone morphogenetic protein-2 (rhBMP-2), have been proven safe and efcacious in improving and accelerating bone healing in orthotopic animal models [20 25]. Osteogenic protein-1 has also been shown in a randomized, prospective study to heal tibia fracture nonunions clinically and radiographically equivalent to autogenous iliac crest bone graft [26]. An osteogenic protein-1 device (OP-1 Implant, Stryker Biotech, Hopkinton, MA) consists of 3.5 mg of rhOP-1 combined with 1 g of highly puried bovine bone derived Type I collagen. The carrier does not have cartilage or bone inductive properties [27]. The nal preparation is freeze-dried and sterilized by gamma irradiation. The device is reconstituted with sterile saline at the time of surgery, producing approximately 4 cc of a granular graft material that offers no structural capacity. The use of an OP-1 Implant in conjunction with autograft or allograft bone offers many potential advantages. Containment of the OP-1 Implant at the site may be enhanced by combination with the bone graft material, resulting in greater and better localized new bone formation. When a structural graft is required or if a bone defect volume is large, the use of the OP-1 Implant alone may not be satisfactory since it has no structural integrity. Under such circumstances there would be a substantial advantage to enhancing the healing potential of the autograft or allograft material so that extensive bone formation and mechanical strength could be achieved more rapidly and reliably. In addition to better defect healing, bone ingrowth to a porous surface may be enhanced with the use of the OP-1 Implant when placed with allograft bone. This should

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speed the rehabilitation process and shorten the time of protected weight bearing and attendant functional disability for the patient.

II. A.

PRECLINICAL EVALUATION OF THE OP-1 IMPLANT Morselized Autograft and Allograft Bone with an OP-1 Implant

Bilateral, critical size, osteoperiosteal segmental defects were surgically created in mid-ulna of 24 adult male dogs [28]. Either autograft bone, allograft bone, or OP-1 Implant alone or various combinations of the OP-1 Implant mixed with allograft or autograft bone were implanted in the segmental bone defects. Combinations used included 67% bone graft/33% OP-1 Implant and 33% bone graft/67% OP-1 Implant. Healing of the defects was assessed radiographically and in biomechanical and histological studies at 12 weeks postoperative. The use of the OP-1 Implant alone or any combination of autograft or allograft bone and the OP-1 Implant improved radiographic, mechanical, and histological healing of the critical sized defects compared to autograft or allograft bone alone (Table 1). Earlier and greater volume of new bone formation was observed with the presence of the OP-1 Implant. The amount of new bone, degree of remodeling, and graft incorporation was proportional to the amount of rhOP-1 implanted. Histologically, only 22% of defects treated with allograft bone alone healed completely, while 67% of defects treated with autograft bone alone were completely healed at 12 weeks. Treatment of defects with the OP-1 Implant alone or any combination of bone graft and the OP-1 Implant healed 93% of cases at 12 weeks. These differences were signicant at p , 0.05. The highest radiographic grade, histological grade, and mechanical strength were achieved with the use of 33% allograft/67% OP-1 Implant, although no signicant differences in healing were observed among the groups containing the OP-1 Implant. Defects treated with any amount of the OP-1 Implant obtained two times the mechanical strength obtained by autograft bone alone at 12 weeks postoperative. B. Cortical Allograft with the OP-1 Implant

Fourteen adult male dogs underwent bilateral onlay allograft strut procedures to the mid-femur utilizing stainless steel cables [29]. In each animal one femur received the OP-1 Implant interposed between the graft and host bone while the contralateral femur strut graft served as an untreated control. The animals were studied with biweekly radiographs and histological and microradiographic evaluation at sacrice periods of at 4, 8, and 12 weeks postoperative. The radiographic results showed that the healing of cortical strut grafts to the femur was improved and accelerated by the addition of the OP-1 Implant

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Table 1 Radiographic, Histological, and Mechanical Testing Evaluation of Defect Healing with the OP-1 Implant and Bone Graft at 12 Weeks Treatment group Allograft At least one cortex bridged All cortices bridged 67% Allograft/33%OP-1 Implant At least one cortex bridged All cortices bridged 33% Allograft/67%OP-1 Implant At least one cortex bridged All cortices bridged Autograft At least one cortex bridged All cortices bridged 67% Autograft/33%OP-1 Implant At least one cortex bridged All cortices bridged 33% Autograft/67%OP-1 Implant At least one cortex bridged All cortices bridged OP-1 Implant At least one cortex bridged All cortices bridged
a b

Radiographica 3/9 0/9 6/6 5/6 6/6 6/6 5/9 4/9 5/6 5/6 5/6 5/6 5/6 5/6

Histologicb 2/9

Mechanicalc 0.15+0.30 (9) 3% 1.60+1.43 (6) 38% 3.18+1.68 (6) 74% 1.33+1.42 (9) 31% 2.76+1.69 (6) 64% 2.85+1.40 (6) 66% 2.74+1.60 (6) 64%

5/6

6/6

6/9

5/6

6/6

5/6

Number of defects/sample size. Number of defects healed histologically/sample size. c Maximum torque to failure (Nm) [mean+SD, (sample size)] and % intact ulna strength.

(Table 2). The OP-1 Implant treated sites also had signicantly greater histological and microradiographic grading scores at all time periods. Rapid formation of new bone and graft incorporation was observed in sites treated with the OP-1 Implant. While cortical strut allografts were shaped intraoperatively to t the femur, immediate postoperative radiographs often revealed that areas of nonconformity existed. Histological sections demonstrated that extensive new bone completely lled gap regions between the host and the strut graft as early as 4 weeks postoperative in sites treated with the OP-1 Implant. In control struts the gaps were slower to ll and were not completely lled with new bone at 8 weeks postoperative. Strut healing with the OP-1 Implant at 4 weeks postoperative was radiographically and histologically superior to control sites at 8 weeks.

Osteogenic Enhancement of Bone Graft Table 2 Radiographic Grading of Cortical Strut Graft Healing with the OP-1 Implant Postoperative week 2 4 6 8 All times Control mean+SD (sample size) 0.04+0.13 (14) 0.82+0.54 (14) 0.80+0.82 (10) 1.88+0.63 (4) 0.65+0.75 (42) OP-1 mean+SD (sample size) 0.86+0.07 (14) 2.50+0.59 (14) 3.30+0.89 (10) 4.13+0.06 (4) 2.30+1.33 (42)

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p-value 0.0005 0.0001 0.0002 0.0194 0.0001

Grade: 0 No visible new bone formation. 1 Minimal new disorganized bone. 2 Disorganized new bone bridging graft to host. 3 Organized new bone of cortical density bridging both ends. 4 Loss of graft-host distinction. 5 Signicant new bone formation and remodeling.

C.

Acetabular Defects with the OP-1 Implant

Acetabular defect healing and bone ingrowth from an acetabular defect into a porous coating was evaluated. Six canines underwent bilateral total hip arthroplasty with a cementless press-t porous coated acetabular component. A defect 8 mm in diameter and 5 mm in depth was created in the superior weightbearing area of each acetabulum. The right defects of each animal were lled with the OP-1 Implant. Each contralateral defect was lled with either allograft bone, left empty (defect healing control), or no defect was created (porous ingrowth control). The degree of defect healing and bone growth into the porous acetabular component surface was quantied histologically and radiographically at 6 weeks postoperative. The OP-1 Implant treated defects healed more completely (37% bone density) than allograft bone (23%) or empty defect (14%) ( p , 0.05) and achieved a bone density equivalent to the no-defect controls (34%). Bone ingrowth also occurred to a signicantly higher degree in the OP-1 Implant (37% bone ingrowth) compared to the allograft (18%) or empty defects (16%) ( p , 0.05) achieving a degree of ingrowth equivalent to the no-defect controls (30%) (Fig. 1). The osteogenic bone protein device was successful in achieving complete healing of the acetabular defects such that the percent cancellous bone volume was not signicantly different from the control hips in which no defect was present. In addition, bone growth into the porous acetabular cup surface was

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Figure 1 Contact radiographs of the acetabular defect areas seen at 6 weeks postsurgery. Examples of (A) an acetabulum with no defect, (B) a defect treated with osteogenic protein, (C) a defect grafted with allograft bone, and (D) an unlled defect (x1). Considerable defect lling with new trabecular bone was observed in the osteogenic protein treated defect (B) as well as gap lling and new bone contact with the porous coated surface of the acetabular component. The defect treated with allograft bone (C) shows some defect lling but only limited new bone contact with the porous surface. Very little new bone was observed lling the empty defect (D) at 6 weeks postoperative.

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comparable to that which occurred without a defect present. In larger defects the combination of the OP-1 Implant with morselized allograft would appear to be an attractive treatment option.

III.

DISCUSSION

Preclinical studies have demonstrated that the osteoinductive capacity of autograft and allograft bone can be improved with the addition of the OP-1 Implant. The combination of autograft or allograft bone with the OP-1 Implant consistently improved the amount and rate of new bone formation compared to bone graft alone. Earlier graft incorporation and consolidation of the new bone and graft was also observed. Although morselized autogenous bone graft in combination with the OP-1 Implant performed similarly in preclinical studies, the complications associated

Figure 2 The OP-1 Implant with morselized allograft bone was placed at the host bone interface of a proximal femoral allograft in a re-revision of a Charnley hip replacement (left). The initial revision had also utilized a proximal femoral allograft due to severe bone loss but failed due to periprosthetic fracture. The radiographic appearance at 6 months (right) postoperative displayed signicant new bone formation in the area where the OP-1 Implant was placed.

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with the donor site can be eliminated by using allograft without reducing the efcacy of the bone graft in the clinical situation. Aside from the risks of bleeding and infection, patients frequently complain of more postoperative pain from the autograft donor site than the primary operative site following a major reconstructive procedure [30,31]. The clinical cases to date suggest efcacy of allograft bone with the OP-1 Implant in promoting new bone formation and graft incorporation (Fig. 2). The clinical use of the OP-1 Implant at the interface of a porous coated acetabular device exhibited extensive new bone formation in histological evaluation of tissue retrieved at revision surgery (Fig. 3). These results are also consistent with preclinical studies that indicate the OP-1 Implant may be efcacious in promoting earlier and greater bone ingrowth or implant apposition [23].

Figure 3 A noncemented total hip replacement was performed for osteoarthritis due to a previous hip fracture. At surgery an OP-1 Implant was placed at the interface of the porous coated acetabular cup and host bone. At 4 weeks postoperative the patient dislocated and was unstable after closed reduction (left). At revision surgery bone from the acetabular bone/prosthesis interface was obtained and examined histologically. Histological evaluation revealed extensive new bone formation (right). A transition from mesenchymal tissue to mature mineralized bone through an osteoid zone with prolic osteoblasts was observed.

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Figure 4 (A) Immediate postoperative radiographic appearance at the distal end of a cortical strut allograft in which the OP-1 Implant was placed in a revision total hip arthroplasty (left) and 3-month radiographic appearance (right) showing new bone formation in the area where the OP-1 Implant was placed. (B) Computed tomography scan at 3 months (left) and 6 months (right) postoperative revealed good new bone formation at the junction of the host femoral cortex and cortical strut where the OP-1 Implant was placed, which matured and consolidated at the latter time period.

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Preclinical study also demonstrated that healing of structural cortical strut allografts to the femur was enhanced by the addition of the OP-1 Implant. Both the quantity and the quality of the graft incorporation was improved based on objective grading of plain x-rays, microradiographs, and histology. The overall scores were signicantly higher in the rhOP-1 treated group and the subscores for new bone formation and graft incorporation were signicantly higher as well. Most importantly, the time course of healing was signicantly accelerated. Clinical application of the OP-1 Implant with a cortical allograft strut demonstrated new bone formation at 12 weeks postoperative (Fig. 4). Consolidation of the new bone and graft was observed at later time periods. Enhancement in strut healing was observed clinically in spite of the more challenging biological environment compared to the preclinical studies. Improving and speeding the course of cortical strut graft healing would be of substantial clinical benet in providing earlier biological and mechanical stability to the construct. These benets should lower the risk of graft nonunion and shorten the time of protected weight bearing and attendant functional disability for the patient. The OP-1 Implant, either alone or in combination with bone graft, appears to be an attractive alternative to autograft bone. The use of rhOP-1 in combination with morselized or structural allograft appears to be an ideal combination. Further work has shown the OP-1 Implant to be equally effective when used with bone graft substitute materials such as calcium phosphate and calcium sulfate materials. Compared to autograft bone alone, new bone formation and graft incorporation is improved with the use of the OP-1 Implant. However, in any clinical application, an osteogenic protein cannot overcome a poor biological or biomechanical environment. Osteogenic proteins require a viable cell source and vascularity, as well as mechanical stability, to induce bone formation and remodeling. Failure to provide the prerequisite biological and mechanical conditions will likely result in graft failure. In addition, maintenance of the osteogenic protein at the implantation site and delivery by an appropriate carrier material are essential for successful osteoinduction.

REFERENCES
1. Brady OH, Garbuz DS, Masri BA, Duncan CP. The treatment of periprosthetic fractures of the femur using cortical onlay allograft struts. Orthop Clin North Am 1999; 30:249 257. Emerson RH Jr, Malinin TI, Cuellar AD, Head WC, Peters PC. Cortical strut allografts in the reconstruction of the femur in revision total hip arthroplasty. A basic science and clinical study. Clin Orthop 1992; 285:35 44.

2.

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6. 7.

8. 9.

10.

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14. 15. 16. 17.

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Head WC, Malinin TI, Mallory TH, Emerson RH Jr. Onlay cortical allografting for the femur. Orthop Clin North Am 1998; 29:307 312. Gazdag AR, Lane JM, Glaser D, Forster RA. Alternatives to autogenous bone graft: efcacy and indications. J Am Acad Orthop Surg 1995; 3:1 8. Hooten JP, Engh CA, Heekin RD, Vinh TN. Structural bulk allografts in acetabular reconstruction: analysis of two grafts retrieved at post-mortem. J Bone Joint Surg 1996; 78B:270 275. Pelker R, Friedlaender GE, Markham TC. Biomechanical properties of bone allografts. Clin Orthop 1983; 174:54 57. Schwarz N, Schlag G, Thurnher M, Eshberger J, Dinges H, Redl H. Fresh autogenic, frozen allogenic, and decalcied allogenic bone grafts in dogs. J Bone Joint Surg 1991; 73-B:787 790. Burchardt H. The biology of bone graft repair. Clin Orthop 1983; 174:28 42. Enneking WF, Burchardt H, Puhl JJ, Piotrowski G. Physical and biological aspects of repair in dog cortical-bone transplants. J Bone Joint Surg 1975; 57-A:237 252. Celeste AJ, Lannazzi JA, Taylor RC, Hewick, RM, Rosen V, Wang EA, Wozney JM. Identication of transforming growth factor-beta superfamily members present in bone inductive protein puried from bovine bone. Proc Natl Acad Sci USA 1990; 87:9843 9847. Ozkaynak E, Rueger DC, Drier EA, Corbett C, Ridge RJ, Sampath TK, Oppermann H. OP-1 cDNA encodes an osteogenic protein in TGF-beta family. EMBO J 1990; 9:2085 2093. Sampath TK, Coughlin JE, Whetstone RM, Banach D, Corbett C, Ridge RJ, Ozkaynak E, Oppermann H, Rueger DC. Bovine osteogenic protein is composed of dimers of OP-1 and BMP-2A, two members of the transforming growth factor-beta superfamily. J Biol Chem 1990; 265:13198 13205. Stevenson S, Cunningham N, Toth J, Davy D, Reddi AH. The effect of osteogenin (a bone morphogenetic protein) on the formation of bone in orthotopic segmental defects in rats. J Bone Joint Surg 1994; 76-A:1676 1687. Urist MR. Bone formation by autoinduction. Science 1965; 150:893 899. Urist MR, Mikulski A, Lietze A. A solubilized and insolubilized bone morphogenetic protein. Proc Natl Acad Sci USA 1979; 76:1828 1832. Wang EA, Rosen V, Cordes P. Purication and characterization of other distinct bone inducing proteins. Proc Natl Acad Sci USA 1988; 87:9484 9488. Sampath TK, Maliakal JC, Hauschka PV, Jones WK, Sasak H, Tucker RF, White KH, Coughin JE, Tucker MM, Pang RH. Recombinant human osteogenic protein-1 (hOP1) induces new bone formation in vivo with a specic activity comparable with natural bovine osteogenic protein and stimulates osteoblast proliferation and differentiation in vitro. J Biol Chem 1992; 267:20352 20362. Urist MR, Delange RJ, Finerman GA. Bone cell differentiation and growth factors. Science 1983; 220:680 686. Wozney JM, Rosen V, Celeste AJ, Mitsock LM, Whitters MJ, Kriz RW, Hewick RM, Wang EA. Novel regulators of bone formation: molecular clones and activities. Science 1988; 242:1528 1534.

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Cook and Barrack Cook SD, Baffes GC, Wolfe MW, Sampath TK, Rueger DC. Recombinant human bone morphogenetic protein-7 induces healing in canine long-bone segmental defect model. Clin Orthop 1994; 301:302 312. Cook SD, Baffes GC, Wolfe MW, Sampath TK, Rueger DC. The effect of recombinant human osteogenic protein-1 (rhOP-1) on healing of large segmental bone defects. J Bone Joint Surg 1994; 76-A:827 838. Cook SD, Dalton JE, Tan EH, Whitecloud TS, Rueger DC. In vivo evaluation of recombinant human osteogenic protein (rhOP-1) implants as a bone graft substitute for spinal fusions. Spine 1994; 19:1655 1663. Cook SD, Rueger DC. Osteogenic protein-1. Biology and applications. Clin Orthop 1996; 324:29 38. Cook SD, Wolfe MW, Salkeld SL, Rueger DC. Effect of recombinant human osteogenic protein-1 on healing of segmental defects in non-human primates. J Bone Joint Surg 1995; 77A:734 750. Gerhart T, Kirker-Head C, Kriz MJ, Schellin S, Wang E. Healing segmental defects in sheep using recombinant human bone morphogenetic protein (BMP-2). Trans Orthop Res Soc 1991; 16:172. Friedlander GE, Perry CR, Cole JD, Cook SD, Cierny G, Muschler GE, Zych GA, Calhoun JH, LaFore AJ, Yin S. Osteogenic protein-1 (bone morphogenetic protein-7) in the treatment of tibial nonunions. J Bone Joint Surg 2001; 83-A(suppl 1):151 158. Sampath TK, Reddi AH. Dissociative extraction and reconstitution of extracellular matrix components involved in local bone differentiation. Proc Natl Acad Sci USA 1981; 78:7599 7603. Salkeld SL, Patron LP, Barrack RL, Cook SD. The effect of osteogenic protein-1 on the healing of segmental bone defects treated with autograft and allograft bone. J Bone Joint Surg 2001; 83-A:803 816. Cook SD, Barrack RL, Santman M, Patron LP, Salkeld SL, Whitcloud TS. Strut healing to the femur with recombinant human osteogenic protein-1. Clin Orthop 2000; 350:50 60. Cockin J. Autologous bone grafting-complications at the donor site. J Bone Joint Surg 1973; 53-B:153. Younger EM, Chapman MW. Morbidity at bone graft donor sites. J Orthop Trauma 1989; 3:192 195.

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22.

23. 24.

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29.

30. 31.

19
Adding Growth Factors to Impacted Grafts
A Good Idea That Might Be Bad
Per Aspenberg
Linkoping University Hospital Linkoping, Sweden

I.

INTRODUCTION

If impaction grafting were suggested as a new method to a bone biologist who did not know it already exists, he would nd it an absurd idea with minimal chance of success. He would point at the introduction of necrotic bone material together with decomposing fat and marrow into an area with extreme demands on mechanical stability, and where early osseous incorporation of the implantin primary procedureshas been shown to be crucial for ultimate success [1,2]. One would think that the only chance for success in such a situation would lie in very fast remodeling of the graft into living, stable bone. However, this is not what we see in histological retrieval studies [3]. The graft is not always completely remodeled, and if so, this takes months and years. Yet the patient is pain-free and walking shortly after the operation.

II.

WHAT MAKES IMPACTION SUCCESSFUL?

I was puzzled by the clinical success of impaction grafting, and our group performed a series of animal experiments trying to understand why impaction grafting works so well. When planning those studies, we leaped to the false conclusion that clinical success must be related to successful osseous incorporation
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of the graft. We therefore tried to nd out which aspect of impaction grafting led to better bone ingrowth in bone chamber experiments. It was when we saw retrieval data that we rst realized that bony incorporation and clinical success might be unrelated and that necrotic bone granula in a brous stroma might constitute an excellent biomaterial for hip revision (see Chapter 15). However, in some of our earlier work we also tried to improve graft incorporation by adding growth factors (bFGF and BMP-7) to the graft. This was successful in the bone chamber model in rats [4,5] but has so far failed in a larger animal model with a loaded prosthesis (unpublished). One principal line of thought now is to use bone stimulatory substances together with bone grafts in the hope of achieving more complete and consistent bone regeneration [6]. Bone morphogenetic protein (BMP) preparations are now available to the clinician and might become valuable in fracture treatment. However, it is also possible to mix this substance with cancellous bone grafts during revision surgery. I fear this could be a serious mistake.

III.

WARNING AGAINST USING GROWTH FACTORS

I would like to warn against adding BMPs or other growth factors to impacted bone grafts for three reasons. First, there is only a small marginal for improvement. The results of impaction grafting are approaching those of primary total joint replacements [7 9]. Suppose there is a large chance that a growth factor decreases the risk of failure, and has a small risk of complications. The vast majority of patients that already have a good prognosis without the factor would run the risk of complications without any benet, and only the few patients with a bad prognosis would, perhaps, be better off. A small risk of complication might then be enough to cause an overall negative effect. Thus, one has to be quite sure that growth factor additives are good, and this will have to be based on theoretical reasoning, because the number of patients and time needed to statistically demonstrate an improvement are excessive. Second, there are considerable theoretical risks with BMPs in this context, because BMPs can also stimulate bone resorption, which has been observed both in vivo [10] and in vitro [11]. Increased resorption poses a risk for a transition phase of increased resorption within the graft before it becomes completely remodeled. This could be detrimental to the mechanical stability. Hostner et al. [12] reported a series of 10 cases of hip revisions where they added a BMP to impacted grafts and followed the result with radiostereometric analysis. In 2 cases they saw dramatic resorption of the graft and early gross failure. This observation caused them to stop the series. It cannot be excluded that this was a rare, random occurrence of resorptionsimply bad luckbut it must be taken as a serious warning. Resorption has also been described in a case of a vertebral

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fracture, where the vertebral body was packed with collagen granules carrying a BMP [10]. Dramatic graft and vertebral resorption caused collapse and gibbosity formation before, eventually, the anabolic effect of the BMP took over and the resorptive lesion became ossied. Third, even if complete and faster osseous remodeling could be achieved with a BMP and the risk of deleterious side effects could be eliminated, this would not necessarily lead to a better clinical result. The composite of necrotic bone and brous scar tissue might be an ideal biomaterial, preferable to complete remodeling. It is clear that a composite of necrotic bone fragments and an armoring brous stroma is sufcient for good function during the rst postoperative months or years [3]. The question is whether complete osseous remodeling is necessary for good long-time results, i.e., whether there must be host bone all the way up to the cement or implant. Also, in cases with good results, large parts of the graft can remain a composite of necrotic bone fragments and a brous stroma. It thus appears that complete osseous remodeling is not necessary. The next question is whether complete osseous remodeling is desirable. Here we can only speculate. The osseous remodeling must start in the periphery, where there is living host bone. It can then work its way as an advancing frontier through the necrotic bone towards the implant. Resorptive activity, however, can normally be increased in front of such a frontier, as, for example, in osteonecrosis of the femoral head [13,14]. Thus, when remodeling nally reaches the vicinity of the implant, resorption might come rst and the prosthesis could loosen. This may not be likely to happen in every case, but it is a theoretical risk that should be considered. One study in goats appears to suggest that loosening can occur in this way, although other explanations for the results are possible [15]. If increased resorption poses the main risk with BMP additives, what about blocking resorption with a bisphosphonate? Bone grafts can be soaked in a bisphosphonate before implantation. In a rat chamber model this completely inhibited graft resorption and also increased the amount of new bone appositioned to the cancellous surfaces [16]. In this model a cylindrical graft is enclosed in a chamber, so that host tissue can only grow into the graft from one end. We can then measure how far into the graft the different tissue components reach. After 6 weeks one sees a brous or granulomatous tissue ingrowth frontier about 5 mm into the graft. Behind this frontier there may be occasional graft resorption, but most of the graft is intact. A bone formation frontier is seen about 2 mm into the graft and, shortly behind, a resorption frontier that takes away both graft and host bone, to form a marrow cavity. When the graft has been pretreated with a bisphosphonate it stays entirely intact, and thus, instead of a marrow cavity, one sees the cancellous graft, with all surfaces covered with new host bone. The bone density is increased several-fold. However, the bone formation frontier has not reached farther into the graft. If a BMP is added to the graft (and no bisphosphonate), the bone formation frontier

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often reaches the other end of the graft, i.e., 5 7 mm into it, and on average the bone ingrowth distance is doubled [5]. Again, a marrow cavity will occupy almost the entire osseous compartment. We combined a bisphosphonate with a BMP in the hope of nding that the increased ingrowth distance due to the BMP would combine with the increased bone density due to the bisphosphonate. However, this was not the case [17]. Indeed, the density was increased as with a bisphosphonate alone, but the ingrowth distance now did not differ from controls. Evidently, resorptive activity within the graft is a prerequiste for the increased ingrowth distance due to the BMP. In other experiments, the graft was compacted to a much higher degree than in clinical practice. Antiresorptive therapy diminished the ingrowth distance below control level, but the ingrowth could then be rescued with a BMP. These experiments indicate that there is an intricate interplay between resorption and the effects of a BMP on graft incorporation and that we cannot be sure that bisphosphonate treatment would solve our problem. The bisphosphonate took away the benet of the BMP. In fracture repair the situation is different: the negative effects of the early resorptive response to a BMP appear to be reduced by bisphosphonate treatment [18]. This is conceivable, because in fracture repair new bone formation is induced outside the preexisting bone that is, or is not, undergoing resorption. Thus, no bone needs to be removed.

IV.

CONCLUSION

I think there is much to lose and little to gain from adding BMPs to impacted bone grafts, mainly due the risk of increased resorption, and bisphosphonate treatment is far from certain to eliminate this problem.

REFERENCES
1. Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg 1995; 77-B:377 383. Karrholm J, Herberts P, Hultmark P, Malchau H, Nivbrant B, Thanner J. Radiostereometry of hip prostheses. Review of methodology and clinical results. Clin Orthop 1997; 344:94 110. Linder L. Cancellous impaction grafting in the human femur: histological and radiographic observations in 6 autopsy femurs and 8 biopsies. Acta Orthop Scand 2000; 71:543 552. Wang JS, Aspenberg P. Basic broblast growth factor enhances bone-graft incorporation: dose and time dependence in rats. J Orthop Res 1996; 14:316 323.

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4.

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16. 17.

18.

Tagil M, Jeppsson C, Aspenberg P. Bone graft incorporation. Effects of osteogenic protein-1 and impaction. Clin Orthop 2000; 371:240 245. Schreurs BW, Buma P. Impaction bone grafting. Acta Orthop Scand 2001; 72:661 663. Ling RS. Cemented revision for femoral failure. Orthopedics 1996; 19:763 764. Slooff TJ, Buma P, Schreurs BW, Schimmel JW, Huiskes R, Gardeniers J. Acetabular and femoral reconstruction with impacted graft and cement. Clin Orthop 1996; 324:108 115. Ornstein L, Atroshi I, franzen H, Johnsson R, Sandquist P, Sundberg M. Early complications after one hundred and forty-four consecutive hip revisions with impacted morselized allograft bone and cement. J Bone Joint Surg 2002; 84A:1323 1328. Laursen M, Hoy K, Hansen ES, Gelineck J, Christensen FB, Bunger CE. Recombinant bone morphogenetic protein-7 as an intracorporal bone growth stimulator in unstable thoracolumbar burst fractures in humans: preliminary results. Eur Spine J 1999; 8:485 490. Kaneko H, Arakawa T, Mano H, Kaneda T, Ogasawara A, Nakagawa M, Toyama Y, Yabe Y, Kumegawa M, Hakeda Y. Direct stimulation of osteoclastic bone resorption by bone morphogenetic protein (BMP)-2 and expression of BMP receptors in mature osteoclasts. Bone 2000; 27:479 486. Hostner J, Karrholm J, Hultmark P. Early failures after femoral revisions, using milled allograft bone mixed with OP-1. 56th meeting Swedish Orthopaedic Association, Vaxjo, Sept 5 8, 2000. Glimcher MJ, Kenzora JE. The biology of osteonecrosis of the human femoral head and its clinical implications: 1. Tissue biology. Clin Orthop 1979; 138:284 309. Gardeniers J. Behaviour of normal, avascular and revascularizing cancellous bone. PhD dissertation, Catholic University of Nijmegen, Nijmegen, The Netherlands, 1988. Schimmel JW, Buma P, Versleyen D, Huiskes R, Slooff TJ. Acetabular reconstruction with impacted morselized cancellous allografts in cemented hip arthroplasty: a histological and biomechanical study on the goat. J Arthroplasty 1998; 13:438 448. Aspenberg P, Astrand J. Bone allografts pretreated with a bisphosphonate are not resorbed. Acta Orthop Scand 2002; 73:20 23. Jeppsson C, Wang J-S, Tagil M, Aspenberg P. No augmentation of morselized and impacted bone graft by OP-1 in a weight-bearing model. Acta Orthop Scand. Accepted for publication. Seeherman HJ, Li XJ, Gavin D, Wozney J, Bouxsein ML. Bisphosphonate limits initial bone resorption without decreasing bone induction in rhBMP-2/ACS treated non-human primate core defects. Bone 2002; 30:44S.

20
Acetabular Bone Impaction Grafting
Classication of the Bone Stock Loss and Surgical Technique
Jean W. M. Gardeniers, Tom J. J. H. Slooff, and B. Willem Schreurs
University Medical Centre Nijmegen Nijmegen, The Netherlands

I.

INTRODUCTION

Acetabular bone defects can be encountered in primary and revision arthroplasty. Primary defects are either congenital or acquired or result from diseases that affects the bony structure of the acetabulum. These defects are associated with inammatory disorders, especially rheumatoid arthritis, congenital hip dysplasia, trauma, osteoarthritis (protrusio acetabuli), previous surgery (acetabular fractures), and metabolic disorders, tumors, infection, or iatrogenic causes. Loss of bone stock is frequently encountered during revision arthroplasty. Aseptic loosening is associated with osteolysis and component migration resulting in damage to acetabular bone, which can be extensive, especially after multiple revisions. Our approach to acetabular reconstruction in both primary and revision surgery is to reconstruct the hip to its anatomical center of rotation, obtain implant stability, and restore acetabular integrity and continuity [1 3]. Surgeons use different techniques depending on the extent of the bone loss, so it is essential to study the available x-rays to plan the operative procedure. For simple bone stock defects, many surgeons use cementless cups, sometimes in combination with bone graft. Many surgeons use a porous-coated hemispherical component xed with screws. In larger defects there is a trend to
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use of oversized jumbo acetabular components or even bi-lobed, oblong, double bubble cups. Other solutions are a high hip center, metal reinforcement ring support with bone graft and structural allograft with a standard or revision components. Several authors advocate the use of rigid metal reinforcement, like the Eichler or Muller ring or the Kerboull plate. Our approach is bone impaction, which we use in all cases. There are several classications of acetabular bone loss. Frequently used classication systems are those of the American Academy of Orthopedic Surgeons by DAntonio et al. [4], Engh and Glassman [5], Chandler and Penenburg [6], Paprosky and Magnus [7], and Garbuz et al. [8]. A classication system should be as simple as possible and should help the surgeon choose the correct technique for acetabular reconstruction. It should also facilitate the comparison of clinical outcome studies presented in the literature. However, all classication systems have limitations. The Paprosky classication is based on the ability of to acetabulum to provide rigid support to uncemented cups [7]. In the type 1 defect there is only limited bone stock loss. The only grafting needed is some morselized bone. In a type 2 defect the acetabular rim still is capable of supporting an uncemented cup and no structural grafts are needed. There may be some superolateral defect in the acetabular rim and a medial defect may exist, but this is not essential for cup stability. Type 3 defects have severe rim defects and require major structural allografts. The Gross classication is based on the type and size of bone graft needed to reconstruct the acetabulum [8]. A type 1 defect is a contained cavitary defect with an intact medial wall and no segmental rim defects. Reconstruction can be performed with either cemented or uncemented cups, in combination with morselized bone graft, which can be impacted in the defect. The type 2 defects are not contained. In type 2A minor column defects are seen, but less than 50% of the acetabulum is defective. They can be reconstructed with a so-called ying buttress structural graft. The type 2B are the major column defects, in which one or both columns are affected and at least 50% of the acetabulum is involved. Extensive structural grafting is needed. For our reconstruction technique of bone impaction grafting with metal mesh to reconstruct segmental defects, the AAOS system was the most useful in predicting the most suitable type of reconstruction. The AAOS Committee on the Hip published the classication for acetabular bone deciency in June 1989 describing the bone defects in both primary and revision reconstruction of the acetabulum [4]. The AAOS classication system can be used in both primary and revision acetabular reconstruction and is becoming more widely quoted in the literature. The classication was intended to be generic in terms of the method of treatment used (Table 1).

Classication of Bone Stock Loss Table 1 Classication of Acetabular Deciencies

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Type I: Segmental deciencies Peripheral Superior Anterior Posterior Central (medial wall defect) Type II: Cavitary deciencies Peripheral Superior Anterior Posterior Central (medial wall intact) Type III: Combined deciencies Type IV: Pelvic discontinuity Type V: Arthrodesis
Source: Ref. [4].

Bone defects are divided into ve categories: Type I: Defects that include the acetabular rim, peripheral and/or medial wall are called segmental. Segmental defects are not contained and can be located anteriorly, superiorly, posteriorly, or centrally in the medial wall. Type II: Defects leaving the rim of the acetabulum intact are cavitary and can be located superiorly, anteriorly, posteriorly, or medially. Debris from third body wear may cause these large cavitary lesions, and their location can vary depending on the type of acetabular component used, the duration of the loosening, or damage caused by infection. Type III: A combination of these two types are classied separately. This is the most common type of defect encountered in revision surgery. A failed cemented acetabular component often migrates superiorly as well as medially, but bone defects can be located in any quadrant of the acetabulum. Type IV: The AAOS classication system also includes pelvic discontinuity, which is the most severe defect that can be encountered during revision arthroplasty and after pelvic trauma. This is dened as a defect in which the anterior and posterior columns are completely separated by a fracture. Type V: Finally, arthrodesis of the hip is included. There is no bone defect, but it is included in the classication because the acetabulum as such no longer exists.

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When acetabular bone impaction grafting is planned, it is important to know whether the defect is contained or not. In contained bone defects, impaction grafting can be done without mesh. If there is a segmental wall defect, it should be closed rst with metal mesh to create a conned cavity into which bone graft can be impacted. Although the AAOS classication is based on radiographs, the denitive classication in Nijmegen is done after exposure of the hip joint during the operation. The primary aim of the technique is to contain and solidly impact trabecular bone chips of substantial size. In any defect this principle is more basic than the classication. The reconstruction must achieve: Full acetabular integrity Full socket coverage with bone or wire mesh Complete connement of the graft Complete xation of the graft Complete xation of the new implant The creation of normal hip mechanics To achieve these goals it is important to understand the classication and use it diligently during the operation.

II. A.

X-CHANGE TECHNIQUE AND THE AAOS CLASSIFICATION Type I: Segmental Defects

In our view this type of defect is rare. Most segmental defects seen in revision surgery are combined cavitary and segmental. The segmental defect must be closed with mesh. After closing the defect, a bone impaction grafting can be performed. The newly created cavitary defect is lled with tightly impacted sequential layers of bone chips (Fig. 1). The acetabular rim is reconstructed as anatomically as possible with wire mesh that is trimmed to the appropriate size and xed solidly with small screws. The new cup is placed against the transverse ligament in the anatomical position. The new acetabular wall is mainly created peripherally and medially.

Figure 1

Reconstruction of a segmental and a combined deciency.

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B.

Type II: Cavitary Deciencies

The acetabular rim and the medial wall is intact. A cavitary defect exists, and it is lled with sequential layers of impacted bone chips to create a new acetabular wall at least 5 mm thick. Again mainly the superior, anterior, and posterior wall is reconstructed (Fig. 2).

C.

Type III: Combined Deciencies: Segmental and Cavitary Defects Combined

Close the defects with wire mesh or small structural grafts taken from the femoral (donor) head. The acetabular rim and the medial wall is reconstructed as anatomically as possible, and the new cup is placed against the transverse ligament. A cavitary defect is created and lled with tightly impacted sequential layers of bone chips. The acetabular wall is mainly created peripherally and medially (Fig. 1, views 3 5).

D.

Type IV: Pelvic Discontinuity

Treat this severe defect as a fracture and follow the rules of fracture treatment. If the fracture is not properly xed, movement exists and primary stability will never be achieved. One of the most important prerequisites of impaction grafting, stability, is absent, and failure is inevitable. Therefore, the anterior and posterior columns must be xed with pelvic reconstruction plates as wire mesh is not strong enough to support the fracture. After plating the columns, the rim defects are anatomically reconstructed with wire mesh or small structural grafts. The medial wall is closed with wire mesh and or structural grafts and a cavitary defect is created. Finally, this defect is lled with layers of impacted bone chips (Fig. 3).

Figure 2 Reconstruction of a cavitary deciency.

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Figure 3

Reconstruction of pelvic discontinuity.

E.

Type V: Arthrodesis

The old acetabulum does not exist anymore and is obliterated. The bone inside the acetabulum is often atrophic and cannot support the cup adequately. After osteotomy of the femoral neck a new acetabulum can be created with acetabular reamers. The osteoporotic bone and walls can be reinforced using impacted bone chips.

F.

Congenital Hip Dysplasia

Congenital hip dysplasia is a special problem, especially the Crowe Class II, III, and IV [9]. The anterior wall is decient due to the abnormal position of the psoas muscle in these cases. The muscle crosses the acetabulum from the lesser trochanter, over the transverse ligament to the rst lumbar vertebral body. From birth onwards it creates a substantial defect in the anterior wall. The high position of the femoral head in the false acetabulum causes an underdeveloped medial wall, true acetabulum, and a decient superior rim. The posterior wall is less affected, but when the cup is positioned against the transverse ligament, this posterior wall needs also reconstructing. After reaming the true and false acetabulum, the anterior wall must be reconstructed using structural graft if a large defect exists. A quarter of the resected autogenous femoral head is xed to the existing acetabulum supplemented with wire mesh xed with small screws to

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the medial wall. The superior rim of the acetabulum is reconstructed with a thick mesh, and a cavitary defect is created and lled with layers of impacted bone chips. The patients own femoral head is used, but often, especially in Crowe class III and IV hips, the amount of bone that can be obtained is inadequate and fresh frozen allograft bone from the bone bank must be added (Fig. 4).

III.

SURGICAL TECHNIQUE

We routinely use the postero-lateral approach with the patient in the lateral position. The patient is stabilized on the operating table with pubic and lumbar pads. In time-consuming revision operations, we use these pads in combinations with a vacuum mattress. The drapes used should facilitate an incision that can be extended to the region of the anterior superior iliac spine if necessary. Care should be taken to ensure free movements of the extremity and provide a clear view of the posterior, lateral, and anterior aspects of the hip joint. In revision surgery, antibiotics should given only after taking the deep cultures. The postero-lateral approach enables extensive exposure of the acetabulum and proximal femur, and a trochanteric osteotomy is seldom necessary. In revision surgery, the major landmarks and the sciatic nerve must be identied to understand the local anatomy, as it may have been disturbed by previous surgery

Figure 4 Reconstruction of congenital hip dysplasia.

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and scarring. Suitable landmarks are the tip of the greater trochanter, the lesser trochanter, the tendineous part of the gluteus maximus muscle, and the borders of the medius and minimus gluteal muscles. Extensive exposure is essential. Aspiration of the hip joint can be performed to obtain joint uid for Gram staining and culture. We try to open the hip joint while conserving the posterior part of the hip capsule. By using stay sutures in this tissue, the sciatic nerve can be protected from direct trauma. Before dislocating the hip joint, the proximal part of the femur is extensively exposed and carefully mobilized to prevent fracturing the often very weak femur. It may be necessary to put circlage wires around the femur before dislocation to prevent an accidental fracture. After dislocation, the femoral component is removed, exposing the entire socket and all scar tissue. Next the cup is removed, avoiding any additional bone damage. Biopsies from the acetabular and femoral interface tissues are obtained and sent for frozen section and bacterial culture. At this stage systemic preoperative antibiotics are administered. The medial wall of the acetabulum is examined meticulously for segmental defects. It is also imperative to determine the strength of the medial wall. If weakness is suspected a medial wall mesh might be considered to prevent fracture during vigorous impaction (Fig. 5, view 1). The complete rim is exposed to examine the peripheral wall for segmental defects. To restore normal hip biomechanics, we always try to reconstruct the cup at the original center of rotation. In most cases the transverse ligament can be located at the caudal part of the acetabulum; it is used as a reference point for positioning the cup. A trial cup is inserted using the ligament as a reference, and the extent of the peripheral wall defect is established. Damage to the superior gluteal muscles and the nerve can be prevented by subperiosteal dissection. The abductor muscles are elevated from the bone to facilitate positioning of the mesh. The mesh is placed on the outer side of the acetabular rim (Fig. 5 view 1). The exible metal mesh is trimmed and adapted to the peripheral wall defect using special scissors and clamps. It must be xed with screws or, at locations with very thin cortical bone, circlage wires. In cases with extensive peripheral wall defects, it sometimes is impossible to achieve stability with mesh on the outer side of the acetabulum. In these special cases, the mesh can be applied to the inner side and xed with more central screws. After all the soft tissue interface remnants have been removed, a small acetabular reamer is used to remove the sclerotic cortical bone. This creates a fresh bleeding trabecular bone bed, which is essential for incorporation of the impacted bone graft. In addition, multiple drill holes should be made to create a bleeding host bone bed and promote vascular invasion into the graft. This is extremely important in the sclerotic areas. Medial wall defects can also be covered by a metal mesh. In most cases, adequate stability of the mesh can be achieved without screw xation.

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Figure 5 Reconstruction technique using wire meshes and bone impaction grafting.

However, the use of one or two very short screws can prevent problems. After closing the segmental wall defects in this way, the acetabulum is contained and the situation has been converted into a cavitary defect. The foundations have been laid for bone impaction grafting.

A.

Preparation of the Bone Graft

All of our long-term data are based on the use of fresh-frozen femoral heads, which were obtained from a local bone bank. We have no experience with processed bone or irradiated bone. The femoral head is stored at 2808C and is

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only used after testing the donor at donation and at 6 months after donation. The femoral head is thawed, cleaned of all soft tissues, and divided into four parts. Morselized grafts are produced by hand, using a bone nibbler. We try to avoid the inclusion of cartilage remnants from the femoral head cartilage. Alternatively, a specially designed bone mill can be used, which produces fairly large bone chips. We recommend a chip size of 7 10 mm, but most commercially available bone mills produce substantially smaller bone chips (2 4 mm), which are not recommended for acetabular reconstruction. B. Acetabular Reconstruction

The acetabular bone bed is cleaned using pressure lavage, and the acetabulum is packed with bone chips. First the small cavities are lled, and then the entire socket, layer by layer. The bone chips are vigorously impacted using special instruments and a hammer (Fig. 5, view 2). If there is any danger of fracturing the weak medial wall, a metal mesh should be used medially to support this structure, but the force of impaction should not be reduced. Start with a small impactor and progress to increasingly larger ones. When the impaction technique has been performed correctly, the graft layer will be stable in the acetabulum after removal of the impactor. The defect is lled layer by layer until the planned cup position has been achieved (Fig. 5, view 3). A substantial layer of bone material must be accumulated of at least 5 mm thick, otherwise the graft may become saturated with bone cement during cementation (Fig. 5, view 4). The last impactor should be 4 mm larger than the proposed cup size to create a sufciently large mantle of cement. The position of the socket should be brought down to the level of the transverse ligament. After impaction, the preexisting enlarged acetabular diameter will have been reduced to standard size. We do not use pressure lavage on the bone graft before cementation. During preparation of the antibiotic-loaded bone cement, pressure is maintained on the graft with the impactor last used. After insertion, the bone cement is pressurized to obtain good interdigitation with the graft (Fig. 5, view 5). Next the cup is guided into position and held in place with a pusher until the cement has set (Fig. 5, view 6). After reconstruction of the femur, it is essential to be very careful during trial reduction. The acetabular reconstructions are strong in compression, but not in tension. During dislocation after the trial reduction, one should control the cup manually and compress it to avoid loosening the cup from the bone graft bed. C. Postoperative Care

Postoperative treatment includes anticoagulation therapy and systemic antibiotics for 24 hours. Immediately after the operation, indomethacin is

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administered for 7 days to prevent heterotopic ossication. Mobilization of the patient is individualized according to the extent of the original defects. In the case of simple cavitary defects, the patient is mobilized within 2 days with partial weight bearing on crutches. We mobilize the more extensive cases after 2 weeks with partial weight bearing. In contrast to our earlier reports, only cases with a extensive defects of the medial wall have 6 weeks of bed rest. All patients are kept on crutches for 3 months.

D.

Critical Factors

The technique is not simple, and the possible pitfalls should always be kept in mind. Critical factors include: 1. Infection should be diagnosed or excluded before surgery by ESR, CRP, WBC and differential WCC, hip aspiration during arthrography, and IgG-scanning. If an infection exists, it should be treated before reconstruction with impacted bone grafting used as a two-stage procedure. 2. Prediction of the acetabular bone loss on radiographs is difcult. A radiograph is a black-and-white two-dimensional projection of a three-dimensional structure. Large metal implants will hide the existing defects, at least partially. Therefore, it is very difcult to clearly classify the defects. A golden rule is that radiographs only show 50% of the true situation. If this is kept in mind, preparation for surgery becomes more reliable. 3. Close all segmental bone defects with meshes; the defects must be contained before impaction. Tight impaction of the chips is only possible in a contained defect and is essential for the primary stability of the acetabular reconstruction. Stability is a prerequisite for ingrowth of the graft and its nal remodeling into lamellar bone. 4. If fractures of the acetabulum or pelvic bone do exist, they should be treated appropriately with plates and screws. Wire mesh is too exible to stabilize such a lesion, and its use in this situation will result in failure. One should be especially wary of pelvic discontinuity. 5. Use large-sized trabecular bone chips on the acetabular side. Our longterm experience is based on trabecular chips of substantial size (7 10 mm) and made by hand using a rongeur. Impacted large trabecular chips can be easily impacted, and they create immediately stability. The initial cup stability is poorer after a reconstruction with smaller bone chips. Remember that most commercial bone mills produce rather small chips (2 4 mm). 6. Use the proper impaction technique. A solid impaction using appropriate impactors and a hammer should be used. Impaction bone

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7.

grafting by reverse reaming is inadequate. Migration is two to three times greater than in cups cemented on to graft impacted with the traditional technique using a hammer and metal impactors. Be aware of the variation among surgeons. The outcome of impaction bone grafting, like every procedure, depends on surgical technique and experience. The way the surgeon prepares for surgical procedures, the knowledge of the exposure, the instruments and implants, preparation of the operating theater staff, and the learning curve of the procedure inuence the outcome. Do not start this technique with the most difcult case. Become familiar with the technique and start on the simpler cavitary defect.

REFERENCES
1. 2. 3. Slooff TJ, van Horn J, Lemmens A, Huiskes R. Bone grafting for total hip replacement in acetabular protrusion. Acta Orthop Scand 1984; 55:593 597. Slooff TJ, Schimmel JW, Buma P. Cemented xation with bone grafts. Orthop Clin North Am 1993; 24:667 677. Slooff T, Buma P, Gardeniers J, Schreurs B, Schimmel J-W, Huiskes R. Revision of the acetabular component: bone packing. In: Callaghan JJ, ed. The Adult Hip. Philadelphia: Lippincott-Raven Publishers, 1998:1449 1459. DAntonio JA, Capello WN, Borden LS, et al. Classication and management of acetabular abnormalities in total hip arthroplasty. Clin Orthop 1989; 243:126 137. Engh GA, Glassman AH. Cementless revision of failed total hip replacement. Instructional Course Lectures of the AAOS 1991:1189 1197. Chandler HP, Penenberg BL, eds. Bone Stock Deciency in Total Hip Replacement: Classication and Management. Thorofare, NJ: Slack Inc., 1989. Paprosky WG, Magnus RE. Principles of bone grafting in revision total hip arthroplasty: acetabular technique. Clin Orthop 1994; 298:147 155. Garbuz D, Morsi E, Mohamed N, Gross AE. Classication and reconstruction in revision acetabular arthroplasty with bone stock deciency. Clin Orthop 1996; 324:98 107. Crowe JF, Massi I, Ranawat CJ. Total hip replacement in congenital dislocation and dysplasia of the hip. J Bone Joint Surg 1979; 61A:15 23.

4. 5. 6. 7. 8.

9.

21
Long-Term Results of Acetabular Reconstruction Using Impaction Bone Grafting and a Cemented Cup
B. Willem Schreurs, Jean W. M. Gardeniers, and Tom J. J. H. Slooff
University Medical Centre Nijmegen Nijmegen, The Netherlands

I.

INTRODUCTION

Although total hip arthroplasty (THA) is one of the most innovative and successful procedures in modern medicine, the number of patients who need a revision is rapidly increasing. In the long-term, the main reason for failure of all types of total hip implants is aseptic loosening. Aseptic loosening is inuenced by a number of factors but will result in osteolysis around the failed implant. In most patients osteolysis is associated with progressive pain, especially when the implant is unstable. However, in some cases there is radiological evidence of progressive osteolysis in patients who are symptom-free. Revision hip replacement when there is extensive bone loss is more demanding, and the greater the bone loss, the less successful is the outcome. Therefore, regular follow-up radiographs, especially in patients at high risk of revision, is mandatory after hip replacement. The most frequent indication for revision of a failed hip arthroplasty is pain, progressive loss of function, increasing physical disability, and in some cases progressive osteolysis on radiographs. During revision surgery, removal of prostheses frequently causes additional loss of bone stock. The loss of bone stock around the prosthesis is therefore the key problem to be addressed in revision surgery. On the acetabular side, loosening causes cavitary bone defects and, in more serious cases, segmental ones with further loss of bone stock. Many acetabular
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reconstruction techniques have been described with both cemented and uncemented cups, and there is little agreement about the best way of managing bone defects. We use tightly impacted morselized cancellous allografts in combination with a cemented cup in all cases with acetabular bone loss, in both primary and revision hip replacement. We think this is an attractive technique because it allows biological repair of damaged bone so should there be a further revision, which can be anticipated as all arthroplasties fail in time, the bone stock will be better than the rst one. Our experience of this technique dates from 1979. The essentials of the impaction grafting technique are: 1. 2. 3. 4. 5. Restoration of the lost bone stock Reconstruction of the original center of rotation of the hip Transformation of a medial or peripheral segmental bone defect into a cavitary defect using metal mesh Stabilizing the bone graft using impactors and vigorous impaction technique Use of a standard acetabular cup with bone cement.

On the acetabular side, we always use 7 10 mm diameter chips, preferably of pure cancellous bone. We do not use this technique in combination with metal reconstruction rings but rely on the stability of the cement graft reconstruction. From the beginning in 1979, we used this technique in patients undergoing primary total hip replacement who had preexisting bone loss as well as in revisions of failed acetabular components. In our center, we now use it in all cases of acetabular bone loss. In a primary total hip replacement with simple protrusio, we use the patients femoral head for bone chips, sometimes with cancellous bone from the proximal femur. However, in primary cases with severe loss of bone stock (e.g., congenital hip dysplasia), we also use fresh frozen femoral head allograft in combination with mesh to reconstruct defects and restore the original center of rotation. Initially in revision cases, we used a combination of autologous human bone from the iliac crest with fresh frozen human femoral head allografts. However, for the last 15 years we have used femoral head allografts alone obtained from our local bone bank. When there has been loss of bone stock loss and a revision is planned, it is essential to distinguish septic from aseptic loosening. If there is any suspicion of infection, technetium scanning, gammaimmunoglobulin scintigraphy, if available, and preoperative aspiration of the hip to obtain cultures should be undertaken. When planning a revision, it is important to recognize that the bone loss and disruption of acetabular anatomy encountered during surgery are frequently much more severe than the preoperative radiographs suggest. Good quality

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antero-posterior, lateral, and oblique plain radiographs are therefore necessary to assess the severity of the anatomical distruption, the extent of bone lysis, and the location of bone cement. In this review we will present the outcome of several follow-up studies performed recently. Readers should realize that the Orthopaedic Department of the University Medical Centre, Nijmegen, is not a high-volume revision center. However, since 1979 we have gained great experience with one revision technique: bone impaction grafting. This is the only technique used in our center, and we have used it for over 20 years. In that time we made only one major modication to the technique. We no longer use metal mesh on top of impacted bone. We used to insert it just before the bone cement in the early years to limit the surface contact between bone cement and graft. At that time, metal-backed cups were very popular, because it was felt that they reduced stress peaks on the acetabulum. The hypothesis turned out to be incorrect, and we concluded that the mesh, like the metal backing, probably had no function, so with the benet of this experience, we decided to cement directly onto impacted bone. During these 20 years we invested a lot of energy in both basic and clinical research into this bone impaction grafting technique. It was the vision of Tom Slooff to extend the study of impaction grafting from clinical to basic scientic research to examine multiple aspects of the technique. Therefore, we developed the infrastructure necessary to perform both biomechanical and histological research into this technique in our center. Thus, in vitro and animal studies supported clinical research in an attempt to understand the technique and dene its limitations. From the beginning, all patients had the same postoperative treatment. This included anticoagulation, systemic antibiotics for 24 hours, and, immediately after surgery, indomethacin for 7 days to prevent heterotopic ossication. Initially after we started the technique, patients were kept in bed for 6 weeks and on crutches for 3 months. Nowadays, mobilization of the patient depends on the extent of the original defect. In simple cavitary defects, the patient is mobilized within 2 days, partially weight bearing on crutches. We mobilize cases with more extensive bone loss after 2 weeks partially weight bearing. Nowadays, only cases with very extensive defects, particularly of the medial wall, have 6 weeks bed rest followed by partial weight bearing of 50% of the body weight. Twelve weeks after surgery full weight bearing is allowed. Many of the results presented are long-term follow-up studies, as these are the only proof of the true clinical value of a revision technique. None of the studies presented are single surgeon series. We tried to prevent selection bias in all these studies. All cases undergoing impaction grafting were prospectively entered in a computer database. When we select a subset of these patients for study, we enter all subsequent patients from this database. Our patient les are nearly complete. We try to trace every patient because we think that loss to follow-up inuences long-term outcome studies. Therefore, in many of our

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studies we present a worst-case scenario, as suggested by Murray et al. [1]. We think that this scenario should be included in every long-term outcome study of hip implants so the reader has easy access to the information and can draw his or her own conclusions as to its reliability. In all studies we used the AAOS scoring system to classify the extent of the acetabular defect [2]. For radiological loosening in all studies, we use the criteria described by DeLee and Charnley [3].

II.

CLINICAL RESULTS

In 1984, we rst reported our short-term results of bone impaction grafting in 40 patients with 43 acetabular reconstructions; 21 were primary cases and 22 revisions after failed total hip arthroplasty [4]. After a follow-up of 2 years there had been no revisions, but radiolucent lines were visible in 5 cases. However, as already explained, only long-term clinical follow-up can prove the true clinical value of a technique. Therefore, we analyzed several groups of patients with long-term follow-up after acetabular bone impaction grafting. We rst focused our clinical research on long-term results of primary and revision total hip arthroplasty. Then we decided to study subsets of these patient groups. We studied the outcome of this technique in patients who were under 50 years at the time of surgery. We use this technique in congenitally dysplastic hips. As total hip replacement in patients with rheumatoid arthritis is associated with poorer results, we studied the outcome of this acetabular reconstruction technique in both primary and revision arthroplasty. A. Acetabular Reconstruction in Primary THA

We studied the outcome of acetabular reconstruction with morselized impacted cancellous bone autograft in primary THA [5] after 10 17 years. Between 1979 and 1986, 69 acetabula were reconstructed in 63 patients with autologous bone chips. At review, 10 patients (9 hips) had been lost to follow-up, leaving 54 patients with 59 hips for review. Unfortunately, the loss to follow-up was relatively high in this study. There were 43 women and 11 men. The average age at surgery was 56 years (range 20 83 years). The preoperative diagnosis was primary osteoarthritis in 42%, secondary osteoarthritis in 27%, and rheumatoid arthritis in 31%. Eleven patients (12 hips) had died within 10 years of the operation; none had undergone revision surgery. The follow-up was 10 years or more (10 17 years, average 12.3 years) in 47 hips (43 patients). The average HHS (Harris Hip Score) was 88 points at the last follow-up. No hip was very painful. Radiologically the defects were classied according to DAntonio et al. [2] as cavitary in 78% and combined segmental and cavitary in 22% of the cases. Radiographically, all grafts united. At an average of 12.3 years follow-up,

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4 revisions had been performed: one for septic loosening (1.5 years after primary surgery) and 3 for aseptic loosening (after 7, 12, and 17 years). There were 3 radiographic failures, but these patients were only mildly symptomatic at review. We concluded that the survival rate for aseptic loosening of primary THA was 94% at 10 17 years follow-up after bone impaction grafting. The survival rate including both revision and radiological loosening as endpoint was 87% at 12.3 years. In a worst-case scenario, including patients lost to follow-up as failures, the survival rate was 76%. B. Follow-Up Study of Acetabular Reconstruction with Bone Impaction Grafting in Patients Under 50 Years

The outcome of primary and revision total hip arthroplasty in young patients with acetabular bone stock loss is poor. We report a long-term review of 41 acetabular reconstructions using impacted morselized bone grafts and a cemented THA in patients younger than 50 (22 49; average 38) years [6]. Reconstruction was performed in 23 primary THA (19 patients) and 18 revision THA (17 patients). Three patients were lost to follow-up, and 3 (4 hips) died within 10 years of surgery, none of which were revised. Thus, 34 hips (30 patients) were reviewed, with an average follow-up of 13 (10 18) years. Two hips were revised for aseptic loosening of the acetabular component 7 and 11 years after surgery. One additional cup was revised after 12 years during a femoral stem revision due to wear and problems matching components, but was well xed. The survival rate of the acetabular reconstruction technique was 94% (95% CI 90 98%), allowing the conclusion that acetabular reconstruction with impacted morselized bone graft and cement gives satisfactory long-term results, even in patients younger than 50 years (Fig. 1). C. Follow-Up Study of Acetabular Reconstruction with Bone Impaction Grafting in Patients with Congenital Hip Dysplasia

With increasing experience, we decided to use this method for all acetabular reconstruction in patients with congenital hip dysplasia [7]. Congenital dysplasia of the hip (CDH) is a relatively common problem, which frequently results in secondary osteoarthritis. This can be treated by joint replacement, but as Charnley and Feagin point out, total hip arthroplasty in patients with CDH is difcult due to acetabular and femoral dysplasia, limb-length inequality, soft tissue contractures, and muscle atrophy. They initially discouraged this procedure in CDH [8].The main problem in joint replacement in CDH patients is how to restore the normal anatomy and obtain a stable xation of the prosthetic components. The use of bone grafts to restore the normal anatomy is biologically attractive, and

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Figure 1 (A) Preoperative x-ray of a 22-year-old woman who had several previous hip surgeries due to a secondary osteoarthritis after neonatal septic arthritis of the left hip. She had a resurfacing hip prosthesis that failed. (B) X-ray 4 months after reconstruction of the hip with bone impaction grafting at age 23. (C) After 21 years the reconstruction looks stable. Clinically the result was excellent: no signs of wear with a complete incorporated bone graft. A beginning osteolytic line is visible in zone 1 of DeLee and Charnley.

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Figure 1 Continued.

conventional acetabular implants can be used. The restoration of bone stock also anticipates future revision, which we consider very important because hips replaced for CDH are usually in relatively young patients. Two types of bone grafts can be used to restore the acetabular bone defects seen in CDH. Harris et al. used solid, structural bone grafts [9]. These bone grafts consisted of large segments of femoral head and neck xed with screws to the ilium. Many reviews of this technique in CDH have reported good clinical results in primary and revision arthroplasty. However, the incorporation of large solid bone grafts is unpredictable, and they may ultimately resorb. This can lead to loosening of the acetabular component in the long term [10,11]. We reviewed the results of 27 acetabular reconstructions in 21 patients with secondary osteoarthritis due to congenital dysplasia of the hip in which the acetabular bone defects were restored with impacted morselized bone grafts in combination with a cemented cup. No patient was lost to follow-up. The average age at surgery was 49 years (range 26 74). There were 20 females and 1 male. Six patients had bilateral procedures. Using Crowes classication [12], the degree of dislocation was stage I in 6 hips, stage II in 8 hips, stage III in 9 hips, and stage IV in 4 hips. During surgery, peripheral segmental bone defects were reconstructed with a metal mesh to support the cup superolaterally. After an average follow-up of 7 years and 7 months (5 15 years), two hips had been revised. The HHS increased after surgery from 37 (range 9 72) preoperatively to 94 (range 70 100) at follow-up ( p , 0.01 in a paired t-test). One cup was

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revised after 27 months for sciatic nerve problems and the other for aseptic loosening of the cup after 12 years. Using the Kaplan-Meier method, the cumulative survival of the acetabular reconstruction was 96.3% after 5 and 10 years. Two hips (7.7%) showed stable radiolucent lines in zone III without migration of the cup. None of the cemented stems were revised. Bone impaction grafting is a safe and attractive method of restoring bone defects in dysplastic hips. D. Acetabular Reconstruction in Revision THA

We carried out a long-term review of impaction grafting in acetabular revision surgery in 1998 [13]. Between 1979 and 1986, 62 acetabular reconstructions had been performed in 58 patients with failed hip prostheses. Two hips were lost to follow-up, leaving data on 56 patients (60 hips). Fifteen patients had died, but none had undergone a re-revision. The indication for revision was aseptic loosening in 56 hips and septic in 4; 2 hips had been revised before once and twice, respectively. There were 13 men and 43 women with a mean age at operation of 59.1 years (range 23 82). Defects were recorded using the DAntonio classication as cavitary in 37 cases and combined cavitary/ segmental defects in 23 cases (10 central segmental and 13 peripheral wall defects). At review after an average of 11.8 years (range 10 15 years), the mean Harris Hip score was 85 (range 53 100). Five cases were revised again: two for culture-proven septic loosening after 3 and 6 years and three for aseptic loosening after 6, 9, and 12 years. Radiological loosening was observed in 4 hips with progressive radiolucent lines in three zones according to DeLee and Charnley [3]. However, most hips were radiologically very stable even in young patients with a long follow-up (Fig. 2). The survival rate for aseptic loosening with this technique for revision surgery was 94% at a mean followup of nearly 12 years. The survival rate for revision due to aseptic loosening or radiological losening was 85%. The worst-case scenario, considering all hips lost to follow-up as having aseptic loosening, showed a survival rate for aseptic loosening of 90%. We have just updated this group of patients. At review in April 2001, 42 reconstructions in 38 patients were available for review with a minimum followup period of 15 years. Nineteen patients with 20 reconstructions in the original group of 62 patients died before the 15th postoperative year. None of these patients had been re-revised, and the deaths were unrelated to hip surgery. Of the original group of 60 hips, 11 had been revised again. The reason for re-revision was septic loosening in 2 cases, aseptic loosening in 7, one for wear after 17 years, and one for problems matching components during a femoral revision. The survival rate for aseptic loosening was 84% at a mean follow-up of 16.5 years.

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Figure 2 (A) Six years after implantation the rst hip arthroplasty had failed with progressive acetabular bone stock loss and migration of the cup in a 54-year-old woman with primary osteoarthrosis. (B) Reconstruction of the acetabulum with bone impaction grafting and a cemented cup. A metal mesh was used on top of the graft. This mesh is no longer used. Cementation is now performed directly on the bone graft. (C) X-ray 11 years after the reconstruction. (D) X-ray 17 years after the reconstruction. No signs of loosening, but a radiolucent line is visible in Zone 3 according to DeLee and Charnley in combination with progessive polyethylene wear.

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Figure 2

Continued.

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E.

Acetabular Bone Impaction in Rheumatoid Arthritis

Approximately 5% of all hip arthroplasties are performed for rheumatoid arthritis based on 92,675 cases in the Swedish national hip multicenter study [14]. Good results can be expected from cemented hip prostheses, but loosening of the cup is the main long-term problem [15,16]. In primary hips in patients with rheumatoid arthritis, bone stock loss due to protrusio acetabuli is frequently observed. Impaction morselized bone grafting in patients with rheumatoid arthritis has proven successful for protrusio in the short and mid-term [17 20]. We studied the long-term outcome of this technique in rheumatoid arthritis [21]. We also reviewed the outcome in patients with rheumatoid arthritis who had an acetabular revision. Revisions in rheumatoid arthritis are difcult because bone quality is poor and there is generally further loss of bone stock. Remarkably, there are few reports in the literature on this group of patients. F. Acetabular Bone Impaction in Rheumatoid Arthritis and a Primary THA

Rosenberg et al. studied the outcome of 36 primary total hip arthroplasties performed in 31 patients with rheumatoid arthritis and protrusio acetabuli who were operated on between 1979 and 1989 [21]. The decient acetabulum was reconstructed with autologous morselized bone grafts from the femoral head. Unfortunately, 3 patients were lost to follow-up. Twelve patients (13 hips) died within 8 years of surgery, none of whom were revised. Sixteen patients (20 hips) were reviewed at an average follow-up of 12 (range 8 18) years. In 2 hips a revision was performed for aseptic loosening of the acetabular component 6.5 and 8 years after primary surgery, respectively. The survival rate of this acetabular reconstruction technique in rheumatoid patients with protrusio acetabuli calculated by Kaplan-Meier analysis was 90% (CI 77 100%). Using a revision or radiographic failure as endpoint, this percentage remains 90%. In a worst-case scenario, considering also loss to follow-up as failure, the survival rate is 86%. We considered that impaction grafting can be of great value in cases with protrusio acetabuli due to rheumatoid arthritis. G. Acetabular Bone Impaction in Rheumatoid Arthritis and a Revision THA

Revision of a failed total hip arthroplasty in a patient with rheumatoid arthritis can be very demanding because of the poor quality of the bone stock. Remarkably, only two reports exist in literature on the outcome of these reconstructions. Raut et al. [22] reported satisfactory clinical results after cemented revision of failed total hip arthroplasties in 41 patients (47 hips) with

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rheumatoid arthritis at an average follow-up of 7 years, but the radiographic results of the socket revisions were not encouraging, with 36% (15 of 41) showing radiological loosening. The loosening was associated with loss of acetabular bone stock. Raut et al. stated that the preservation of acetabular bone stock is the key to a good result from revision arthroplasty and that the use of bone grafting should be considered when the acetabular bone stock is decient. Recently, the results of acetabular revisions with uncemented acetabular components in patients with rheumatoid arthritis were presented [23]. This study conrmed that revisions in rheumatoid patients are difcult. Cementless acetabular revisions had a low rate of success in these patients. The survival rate was 44% at 9 years using Kaplan-Meier analysis, with failure of the acetabular component as the endpoint. We studied the outcome of the clinical and radiological outcomes of acetabular revisions using the bone impaction grafting technique and a cemented polyethylene cup at midterm follow-up in rheumatoid arthritis [24]. Thirty-ve consecutive acetabular revisions were performed in 28 patients with rheumatoid arthritis using bone impaction grafting and a cemented cup. The average age at revision was 57 years (range 31 73 years). Patients were reviewed at a minimal follow-up of 3 years (range 3 14 years; average follow-up 7.5 years). At review no patient was lost to follow-up, but ve patients (6 hips) had died. Acetabular bone stock defects were classied by the AAOS method as cavitary (11 cases) or combined segmental/cavitary (24 cases). Five deceased patients (6 hips) had been doing well up to their latest follow-up. After an average follow-up of 7 years and 6 months, six patients (6 hips) had a repeat revision. At review the average Harris hip score was 82 (range 52 97), hip pain was absent or mild in 21 of the 23 hips (91%). Radiographic analysis of all 29 hips that were not revised showed loosening in one patient, and two other hips had a nonprogressive radiolucent line in one zone. Excluding the septic loosenings, the survival rate for aseptic loosening using Kaplan-Meier analysis for this technique at a follow-up of 8 years is 90% (95% CI 80 100%). Therefore, acetabular revision with impaction bone grafting and a cemented cup is promising in rheumatoid revision surgery (Fig. 3).

III.

DISCUSSION AND RECOMMENDATIONS

Revision arthroplasty on the acetabular side is still a controversial issue among orthopedic surgeons. A variety of reconstructive techniques has been suggested. In revisions, the surgeon has to decide how best to deal with the loss of bone stock, restore the original center of rotation, and stabilize the new implant. Comparison of outcomes of different techniques is difcult because several

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Figure 3 (a) Radiographs of a 35-year-old male with rheumatoid arthritis and bilateral loosenings of cemented hip components. On the right side loosening of both the cup and stem is evident; on the left side a complete protrusio of the cup into the pelvis is seen and the stem has pivoted out. (b) Both hips were reconstructed within one month using impaction bone grafting. On the right side a small metal mesh was used to close a limited medial wall defect, the defect was impacted, and the stem was recemented. On the left side the medial wall defect was closed with a large metal meshes and a large reconstruction was performed. On top of the graft a metal mesh was placed and a cup was cemented. (The use of this metal mesh on top of the layer of grafts has been abandoned since 1990.) (c) Radiographs obtained 12 years after the reconstructions demonstrate that the limited migration of the left cup in the axial direction, noted in the initial months after the reconstructions, had stabilized. Both hips were clinically well functioning. There were no signs of radiological failure, and the grafts seemed to be incorporated according to the used criteria.

methods have been used to classify the preoperative bone defect. More uniformity in classication is therefore required. Cemented xation in revision is less effective when bone stock has been lost and it is impossible to achieve adequate cement penetration into the sclerotic

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Figure 3

Continued.

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host bone that remains. However, this method can be considered in very elderly patients with limited life expectancy. In cases with large rim defects, several types of reinforcement ring have been used in combination with bone grafting and cement. We wish to stress that the use of morselized bone grafts in combination with metal reinforcement rings is a totally different method from the impaction grafting that we recommend. Reports showed good long-term results at midterm follow-up. However, we are critical of this method for two reasons. In our view it is essential that impacted bone grafts are loaded, and load protection by a metal shell hampers the process of graft incorporation. The other point is that in time the rigid metal reinforcement ring may fail because of the mismatch with the more elastic pelvic bone. After failure of a metal ring, the defect is likely to be larger than the original one. The quality of the bone graft will be inferior due to the limited ingrowth, so the surgical problems at the second revision will be even more challenging. Structural femoral head auto- and allografts have been used to reconstruct large acetabular rim defects. However, long-term results show failure in 29% after a mean follow-up of 16.5 years [25]. The clinical outcome is not predictable, and graft resorption occurs. Both the xation technique and incomplete incorporation of the structural grafts may account for this. Hooten et al. [11] reported on two graft retrievals after structural bulk allografts had been used for acetabular reconstruction. Although the patients performed well clinically and the radiographs showed incorporation of graft to the host bone, microscopically there was limited bony union. Revascularization extended no more than 2 mm into the structural graft. Even after 48 months, allograft revascularization and remodeling were minimal. Some reports on cementless acetabular components showed excellent short-term and intermediate results, whereas others were clearly inferior. These cementless components were very often supplemented by bone grafts. Morselized bone grafting successfully restored loss of bone stock in cavitary and noncontained medial wall defects. In cavitary defects and in defects with more than 80% of the acetabular rim intact, the results were excellent at midterm follow-up [26,27]. The results of uncemented cups in combination with more severe rim defects remain unclear. This gives rise to serious concern regarding the long-term results of uncemented acetabular revision. Another problem is the severe osteolysis seen in the longer term in uncemented cups used for primary hip replacement. If osteolysis also occurs in revision cases, the outcome will probably be disastrous. Very large uncemented implants have been used in cases with extensive loss of bone stock. Although a large jumbo cup or a double bubble cup can be used to restore the original center of rotation, long-term success rates for these procedures has not been reported. However, should these big implants fail, there will be extensive loss of bone stock.

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In our view, a biological technique should be used to reconstruct skeletal defects, and we now have more than 20 years of experience with impaction bone grafting in combination with cement. Long-term data are available for both primary and revision total hip arthroplasty with preexisting bone stock loss. Although the cup survival rate declines after 10 15 years, the results are good. The application of this technique to larger segmental defects is technically far more demanding. In general, surgeon and surgically related factors play the greatest role in the success or failure of a revision procedure. Therefore, before a surgeon starts acetabular reconstruction with impaction grafting and cement, he or she should become familiar as possible with the clinical, technical, and scientic details of the method. It is important to be aware that a wide exposure is essential to position the mesh to contain peripheral segmental defects. Preparation of the bone graft material is also important. Our long-term experience in revision surgery is solely based on the use of fresh-frozen femoral heads. The size of the chips is a crucial factor. Almost all commercial mills produce chips that are far too small for impaction grafting in the acetabulum (2 4 mm). We always produced our chips by hand using a nibbler until a special type of bone mill (Noviomagus bone mill) was developed that can produce chips of 7 10 mm. We never wash the bone graft after impaction. Although this may be possible using a sieve to protect the bone graft and this may improve cement penetration into the graft, a potential drawback is that potentially important biological factors (e.g., BMP, growth factors) may be diluted or washed out. We studied the stability of acetabular cups after reconstruction with impaction bone grafting in fresh-frozen human pelvises [28]. In several experiments the size of the bone chips had a signicant effect on stability. Large bone chips improve the initial stability of a cemented cup after bone impaction grafting. When large bone chips were used, the outcome was more predictable, more consistent, and less surgeon-dependent. Therefore, we strongly recommend using 0.7 1.0 cm bone chips for acetabular reconstruction, because the outcome is more predictable. Concern has been expressed about cement coming into contact with impacted morselized bone graft material. However, in 1982 83, Roffman et al. [29] showed that contact with bone cement did not impair incorporation of the bone graft. We conrmed this in two goat models in which we studied the outcome of bone impaction grafting on the acetabular and femoral sides [30 32]. Heekin et al. reported incorporation in retrievals after morselized bone grafting [33]. In 1996 our group reported on the histology of acetabular impaction grafting in 8 THA cases performed at our center [34]. More recently, we have re-reviewed all the biopsies obtained for histological investigation from acetabular reconstructions [35]. This new series contains a number of larger biopsies. Histology specimens were available on 25 biopsies from 20 patients. In general, bone incorporation was more or less complete in all cases. A remarkable

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observation was that remnants of cartilage were visible in the reconstruction, even after longer follow-up. The remnants were almost always found in the reconstructions with milled bone. All cartilage should be removed before milling a head. This cartilage will not remodel into bone, but it will have an adverse mechanical effect on the reconstruction [36]. Bone impaction grafting is very suitable for acetabular reconstruction in primary and revision surgery. It provides a biological solution for loss of acetabular bone stock. However, the method is technically highly demanding, and great care must be taken to fully understand the principles of the technique.

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1. 2. Murray DW, Britton AR, Bulstrode CJK. Loss to follow-up matters. J Bone Joint Surg 1997; 79-B:245 247. DAntonio JA, Capello WN, Borden LS, Bargar WL, Bierbaum BF, Boettcher WG, Steinberg ME, Stulberg SD, Wedge JH. Classication and management of acetabular abnormalities in total hip arthroplasty. Clin Orthop 1989; 243:126 137. DeLee JG, Charnley J. Radiological demarcation of cemented sockets in total hip replacement. Clin Orhop 1976; 121:20 32. Slooff TJJH, Huiskes R, van Horn JR, Lemmens AJ. Bone grafting in total hip replacement for acetabular protrusio. Acta Orthop Scand 1984; 55:593 596. Welten MLM, Schreurs BW, Buma P, Verdonschot N, Slooff TJJH. Acetabular reconstruction with impacted morcellized cancellous bone autograft and cemented primary total hip arthroplasty. J Arthroplasty 2000; 15:819 825. Schreurs BW, van Tienen TG, Buma P, Verdonschot N, Gardeniers JWM, Slooff TJJH. Favorable results of acetabular reconstruction with impacted morsellized bone grafts in patients younger than 50 years. Acta Orthop Scand 2001; 72:120 126. Bolder SB, Melenhorst J, Gardeniers JWM, Slooff TJJH, Veth RPH, Schreurs BW. Cemented total hip arthroplasty with impacted morcellized bone-grafts to restore acetabular bone defects in congenital hip dysplasia. J Arthroplasty 2001; 16(suppl 1):164 169. Charnley J, Feagin JA. Low friction arthroplasty in congenital subluxation of the hip. Clin Orthop 1973; 91:98 113. Harris WH, Crothers O, Oh I. Total hip replacement and femoral head grafting for severe acetabular deciencies in adults. J Bone Joint Surg 1977; 59A:752 759. Enneking WF, Mindell ER. Observations in massive retrieved human allografts. J Bone Joint Surg 1991; 73A:1123 1142. Hooten JP, Engh CA, Heekin RD, Vinh TN. Structural bulk allografts in acetabular reconstruction: analysis of two grafts retrieved post-mortem. J Bone Joint Surg 1996; 78B:270 275. Crowe JF, Massi I, Ranawat CJ. Total hip replacement in congenital dislocation and dysplasia of the hip. J Bone Joint Surg 1979; 61A:15 23.

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Schreurs et al. Schreurs BW, Slooff TJJH, Buma P, Gardeniers JWM, Huiskes R. Acetabular reconstruction with impacted morsellised cancellous bone graft and cement. A 10to 15 year follow-up of 60 revision arthroplasties. J Bone Joint Surg 1998; 80B:391 395. Malchau H, Herberts P, Ahnfelt L. Prognosis of total hip replacement in Sweden: follow-up of 92,675 operations performed 1978 1990. Acta Orthop Scand 1993; 64:497 506. Creighton MG, Callaghan JJ, Olejniczak JP, Johnston RC. Total hip arthroplasty in patients who have rheumatoid arthritis. A minimum ten-years follow-up study. J Bone Joint Surg 1998; 80-A:1439 1446. Lehtimaki MY, Kautiainen H, Lehto U, Hamalainen MM. Charnley low-friction arthroplasty in rheumatoid patients: a survival study up to 20 years. J Arthroplasty 1999; 14:657 661. Hastings DE, Parker SM. Protrusio acetabuli in rheumatoid arthritis. Clin Orthop 1975; 108:76 84. Ranawat CS, Dorr LD, Inglis AE. Total hip replacement in protrusio acetabuli of rheumatoid arthritis. J Bone Joint Surg 1980; 62-A:1059 1064. Johnsson R, Ekelund L, Zygmunt S, Lidren L. Total hip replacement with spongious bone graft for acetabular protrusion in patients with rheumatoid arthritis. Acta Orthop Scand 1984; 55:510 513. Gates HS, McCollum DE, Nunley JA. Bone grafting in total hip arthroplasty for protrusio acetabuli. J Bone Joint Surg 1990; 72-A:248 252. Rosenberg WJ, Schreurs BW, Waal Malejt MC de, Veth RPH, Slooff TJJH. Impacted morsellized bone grafting and cemented primary total hip arthroplasty for acetabular protrusion in patients with rheumatoid arthritis. An 8- to 18- year followup study of 36 hips. Acta Orthop Scand 2000; 71:143 146. Raut VV, Siney PD, Wroblewski BM. Cemented revision Charnley low-friction arthroplasty in patients with rheumatoid arthritis. J Bone Joint Surg 1994; 76-B:909911. Mont MA, Domb B, Rajadhyaksha AD, Padden DA, Jones LC, Hungerford DS. The fate of revised uncemented acetabular components in patients with rheumatoid arthritis. Clin Orthop 2002; 400:140 148. Schreurs BW, Thien MT, de Waal Malejt MC, Buma P, Veth RPH, Slooff THJJH. Acetabular revision with impacted morselized cancellous bone graft and a cemented cup in patients with rheumatoid arthritis: three to fourteen-year follow-up. J Bone Joint Surg Am 2003; 85-A:647652. Shinar AA, Harris WH. Bulk structural autogenous grafts and allografts for reconstruction of the acetabulum in total hip arthroplasty. Sixteen year average follow-up. J Bone Joint Surg 1997; 79-A:159 168. Silverton CD, Rosenberg AG, Sheinkop MB, Kull LR, Galante JO. Revision of the acetabular component without cement after total hip arthroplasty: a follow-up note at 7 to 11 years. J Bone Joint Surg 1996; 78A:1366 1370. Padgett DE, Kull L, Rosenberg A, Sumner DR, Galante JO. Revision of the acetabular component without cement after total hip arthroplasty: Three to six years follow-up. J Bone Joint Surg 1993; 75A:663 673.

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Verdonschot N, Schreurs BW, van Unen JMJ, Slooff TJJH, Huiskes R. Stability after acetabulum reconstruction with morsellized grafts is less surgical dependent when larger grafts are used. Proceedings of the Forty-Fifth Annual Meeting of the Orthopaedic Research Society, Anaheim, CA, Feb 5 8, 1999. Roffman M, Silberman M, Mendes D. Incorporation of bone graft covered with methylmethacrylate onto the acetabular wall. Acta Orthop Scand 1983; 54:580 586. Schimmel JW, Buma P, Versleyen D, Huiskes R, Slooff TJJH. Acetabular reconstruction with impacted morsellized cancellous allografts in cemented hip arthroplasty. J Arthroplasty 1998; 13:438 448. Schreurs BW, Buma P, Huiskes R, Slagter JL, Slooff TJJH. Morsellized allografts for xation of the hip prosthesis femoral component: a mechanical and histological study in the goat. Acta Orthop Scand 1994; 65:267 275. Schreurs BW, Huiskes R, Buma P, Slooff TJJH. Biomechanical and histological evaluation of a hydroxyapatite-coated titanium femoral stem xed with an intramedullary morsellized bone grafting technique: an animal experiment on goats. Biomaterials 1996; 17:1177 1186. Heekin RD, Engh CA, Vinh T. Morselized allograft in acetabular reconstruction: a postmortem retrieval analysis. Clin Orthop 1995; 319:184 190. Buma P, Lamerigts N, Schreurs BW, Gardeniers J, versleyen D, Slooff TJJH Impacted graft incorporation after cemented acetabular revision. Acta Orthop Scand 1996; 67:536 540. Van der Donk S, Buma P, Slooff TJJH, Gardeniers JWM, Schreurs BW. Incorporation of morselized bone grafts: a study of 24 acetabular biopsy specimens. Clin Orthop 2002; 396:131 141. Bavadekar A, Cornu O, Godts B, Delloye C, van Tomme J, Banse X. Stiffness and compactness of morselized grafts during impaction: an in vitro study with human femoral heads. Acta Orthop Scand 2001; (5):470 477.

22
Impaction Bone Technique at the Acetabular Side
E. Winter
BG Unfallklinik Tubingen, Germany

I.

INTRODUCTION

There is an ever-increasing number of failed hip arthroplasties displaying massive deciencies of acetabular bone stock combined with segmental and cavitary defects [1 5]. Unfortunately, no single technique is likely to provide a solution to span the full spectrum of possible acetabular defects. But contained acetabular defects can generally be treated by grafting of the defects and inserting a hemispherical acetabular component using screws and no cement [6 9]. A valuable alternative to augmentation of the decient acetabulum is the placement of a hemispherical acetabular component. This is then secured, with screws and not cement, onto the superior margin of the acetabular defect, resulting in a standard hip center as described by Woolson and Adamson [10] or in a high hip center as described by Dearborn and Harris [11]. Another option is to ll the superior acetabular defect with metal in the form of an oblong acetabular component [12]. As a result, the superior hemisphere of this implant remains securely in contact with the host bone above, allowing the establishment of a normal hip center. When using an oblong cup, it is necessary to remove additional bone in order to accommodate the shape of this implant. Still another alternative treatment is the use of bulk allografts, whose failure rate has been shown to increase over time [13,14]. Because of the tendency of bulk allografts to collapse or dissolve over time, some authors have instead advocated the usage of acetabular reinforcement rings.
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In the early 1980s, the Schneider-Burch [15] ring was introduced. This device came equipped with peripheral anges, which were screwed onto the periacetabular pelvic bone in order to provide additional stability. Originally it was common practice to ll the bone defects with bone cement. But this technique frequently led to early complications with further loss of bone stock and secondary loosening of the antiprotrusio ring [1,16 21]. Today, the majority of authors are convinced that massive acetabular bone deciencies should be lled with bone grafts. The use of either autograft or allograft in combination with reinforcement rings has been proven to be successful in long-term follow-up studies [1,22 25]. However, it has been questioned whether transplanted cryopreserved allogenic bone grafts can lead to vital acetabular bone stock. While several authors have reported failure of acetabular reconstruction with cryopreserved allogenic bone grafts [26,27], other clinical investigations have described cryopreserved allogenic cancellous grafts as being successful in clinical use [1,25,28 32]. We present a study that was undertaken to evaluate the long-term results, clinically and radiologically, using cryopreserved allogenic morselized bone graft and a Schneider-Burch antiprotrusio cage to manage Type III and IV acetabular deciencies (AAOS Classication) in revision hip arthroplasty.

II. A.

MATERIALS AND METHODS Patient Study Group

During the period from January 1, 1988, to January 1, 1994, 41 patients (41 hips) with acetabular defects (Type III and IV [33]) after hip arthroplasty due to coxarthrosis were operated on consecutively. The type and extent of the acetabular deciencies had been determined from preoperative radiographs and intraoperative assessments. Failed arthroplasties were diagnosed to be aseptic in all cases. Of the 41 patients, 2 died of unrelated causes 4 and 6 years after surgery, and one patient was unavailable for the follow-up examination. The remaining 38 patients were assessed clinically and radiologically before the operation and, on average, 7.3 years (range 4.2 9.4 years) after their operation. There were 21 right and 17 left hips operated on in 38 patients. These patients included 24 women and 14 men with an average age at the time of the operation of 76 (range 49 83) years. Thirty-four patients had a Type III deciency, and four patients had a Type IV deciency [33]. In 27 patients, femoral stem revision had to be performed as well because of aseptic loosening. In 10 instances, the cemented stem was replaced with another cemented stem, while in the remaining 17 patients the cemented stem had to be removed and a revision stem was inserted using a cementless technique.

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B.

Operative Technique

Arthroplasty was performed in a vertical laminar-ow operating room. The lateral transgluteal approach was used in all cases. First, the failed acetabular component was exposed and removed. The full extent of the defect became apparent only after the entire acetabulum had been debrided of cement and scarred capsular tissue. This was performed with curettes, osteotomes, and hemispherical reamers in order to achieve a well-vascularized recipient bed. Care was taken to avoid extending the size of the existing defect. Then, allogenic cancellous frozen bone from the bone bank was morselized (chip size approximately 1 cm3). Bone grafts were obtained from femoral heads stored at 2808C according to standard bone bank guidelines. Depending on the size of the defect, cancellous bone of up to three femoral heads was used. The cancellous chips were pressed into the acetabular cavity and carefully condensed. The anges of the Schneider-Burch reinforcement ring (Protek AG, Berne, Switzerland) were bent into shape in order to comply with the specic anatomy of the acetabular region. The ring was then positioned by buttressing its inferior ange into the ischium, preferably with screws. The superior ange of the metal ring was xed to the ilium with cancellous bone screws. This should result in a stable composite (composed of the load bearing host bone, allograft, and implant) with a compressed bone graft located beneath the ring. A polyethylene cup was then cemented into the metal cage in a correct position with a thin lm of cement (2 3 mm). In order to avoid too much penetration of cement through the porous ring, the bone graft had to be well compressed. C. Rehabilitation Program

Patients were maintained at bedrest postoperatively for one week if only the changing of the acetabular component or a proximal femur approach became necessary. Patients were maintained at bedrest for 2 weeks if a transfemoral approach was used. Intensive physical therapy began when patients were at bedrest from the rst postoperative day on. The patients had been carefully advised to avoid bending the affected hip joint more than 908 and to avoid forced rotation, especially forced internal rotation. Slight abduction was ensured for 14 days using a wedged pillow. Partial weight bearing with 20 kg was recommended for 6 weeks, and in the case of a transfemoral approach for up to 12 weeks. Clinical and radiological follow-up examinations were performed 3 months, 6 months, and one year after the operation and, then, once a year. D. Clinical Follow-Up Examination

Thirty-eight patients (38 hips) were assessed clinically and radiologically before and after their operation. Clinical follow-up studies had been performed on

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average 7.3 years (range 4.2 9.4 years) after surgery according to Johnston et al. [34]. These guidelines consist of a comprehensive list of questions and examinations covering the following categories: degree of pain, level of activity, ability of putting on shoes and socks, ability of ascending and descending stairs, ability of changing position from sitting to standing, patients walking capacity, ability to walk without support, and ability to walk with support. Additionally, the Harris hip score [35] was used to grade the clinical results. The patients expressed their subjective impression of the surgical result as very satised, satised, or dissatised. The physical examination included assessing the range of hip motion before the operation and at the time of the follow-up. In addition, the difference in leg length was recorded at the time of the follow-up examination. Preoperative data (patients records and questionnaires) were compared with the parameters evaluated at the time of the follow-up examination. E. Radiographic Evaluation

In all 38 cases a detailed radiographic analysis was performed at the time of the clinical follow-up, which involved the determination of the migration of the acetabular implants as well as the assessment of the grafted area. Immediate postoperative and nal follow-up radiographs were performed. The following parameters were measured according to Peters et al. [25]: acetabular index (AI), horizontal migration (HM), and vertical migration (VM) (Fig. 1) on immediate postoperative and nal follow-up radiographs. The bone/implant interface was also examined for the presence of complete or partial radiolucencies. Based on the appearance of trabecular remodeling, the bone graft was determined as either incorporated or not incorporated. Trabecular remodeling within the grafted area was assumed in the case of equal radiomorphological appearance (graft density and architecture) of the grafted area and the surrounding native bone, as described earlier [36 38]. The three zones delineated by De Lee and Charnley [39] were used to report the location of the radiolucency and to give some indication of its extent. Furthermore, we analyzed whether the reinforcement ring underwent tilting and compared the x-rays of the shape of the ring shortly after the operation and at the time of the follow-up. F. Statistical Methods

Continuous paired observations, for example, range of hip motion, were analyzed before and after treatment using the paired t-test. Ordinal data (for example degree of pain) were tested for homogeneity of the marginal distributions of the corresponding transition matrices according to the Mann-Whitney test for ordinal independent observations as generalized by Agresti [40]. This involved

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Figure 1 Diagram of a bilateral acetabular reconstruction showing the radiographic parameters with which migration is analyzed. Line A: reference line through the teardrop gure. Line B: perpendicular reference line through the teardrop gure. Line C: line through the axis of the antiprotrusio cage. HM horizontal migration; VM vertical migration; AI acetabular index.

generating contingency tables and evaluating whether the differences in the marginal distributions of these tables signicantly differed from zero. This method estimates the probability of how extensively the preoperative and postoperative severity of a condition differs.

III. A.

RESULTS Clinical Results

The patients opinion of the surgical results yielded the following: Fourteen patients were very satised, 22 were satised, and 2 were dissatised. We compared all the individual parameters preoperatively and at the time of the follow-up examination as described by Johnston et al. [34]: degree of pain, level of activity, ability to put on shoes and socks, ability to ascend, and descend stairs, ability to change position from sitting to standing, patients walking capacity, and ability to walk with and without support. The results showed that all of these

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parameters had signicantly improved at the time of the follow-up examination ( p , 0.0001), even in the two patients who were dissatised. The range of motion of the affected hip had signicantly improved ( p , 0.005) at the time of the follow-up examination in all patients compared to the joint motion prior to surgery. Only operated legs showed an increase in length. The average measured increase at the time of the follow-up examination was 0.8 cm (range 0.5 3.0 cm). The average Harris hip score [35] was 82.6 (range 58.2 94.9) at the last follow-up examination. This included 11 (29%) patients who had an excellent score (90 100 points), 14 (37%) who had a good score (80 89 points), 9 (24%) with a fair score (70 79 points), and 4 (10%) who had a poor score (,70 points).

B.

Radiographic Results

Evaluating the migration of the acetabular implants was crucial in the analysis of the radiographs. No signicant differences between the immediate postoperative and follow-up values were detected with respect to the acetabular index, horizontal migration, and vertical migration (Fig. 1). No tilting of the reinforcement ring was found. These ndings indicate that no signicant migration occurred in any patient ( p , 0.0005). Complete trabeculation and integration of the bony structures of the area in which the graft was implanted were observed at the time of the follow-up examination in the three acetabular zones dened by De Lee and Charnley [39]. The radiographic morphology of the graft appeared to match that of the surrounding native bone. According to the described criteria [4,30,35], this was interpreted as a sign of mature woven bone formation within the region of the graft.

C.

Complications

Few perioperative complications were observed. In one case the loosened acetabulur cup dislocated deeply into the lesser pelvis during the revision operation. Despite this, we were able to remove the cup using the lateral approach. In another case, an intraoperative fracture of a cancellous bone screw in the ilium occurred. General postoperative complications included a total of 11 successfully treated conditions caused by nonsurgical complications: 2 cases of bronchitis, 2 gastritis, 5 urinary infections, and despite low-dose heparinization, 2 cases of deep venous thrombosis without severe sequelae. Local postoperative complications included 6 hematoma, of which 3 were surgically drained, and 2 subcutaneous inammatory reactions were treated conservatively. Revision surgery was required in one patient with a deep infection, but it was possible to preserve the implant. One early postoperative dislocation occurred. After

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Figure 2 (A) Anteroposterior and axial radiograph of the hip of a 68-year-old woman, made 9 years after a total hip arthroplasty performed with cement, showing a type III combined defect [33]. (B) Radiograph made 6 months after a revision hip arthroplasty was performed with use of a morselized, cryopreserved, cancellous allograft bone, a Schneider-Burch reinforcement ring, and a cup inserted into the ring with cement. (C) Radiograph made 5 years after revision hip arthroplasty, showing un-changed position of the implants and a complete trabeculation of the bony structures of the area in which the graft was implanted.

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reposition followed by conservative treatment (2 weeks of bed rest and an antirotation cast), no further dislocation took place.

IV.

DISCUSSION

The majority of published studies we are aware of have concurred that the presence of severe multisegmental acetabular defects is an indication that an acetabular reconstruction procedure coupled with a metal reinforcement ring and bone graft should be used [23,25,41 43]. A large number of authors have recommended using the Schneider-Burch reinforcement ring with a cranial and caudal ange, which can be secured to the ilium and ischium [21,23,25,44,45]. This method provides a high degree of initial stability and allows early weight bearing in the patient. The ring also protects the graft implanted beneath from mechanical irritation as well as promotes the bone remodeling process. The close t between the graft and the acetabulum together with mechanical immobility and stability are regarded as a crucial precondition for the remodeling of the allograft [1,28,29,46]. The studies performed by Haentjens et al. [47], Schatzker et al. [21], and Zehntner and Ganz [43] illustrated the limits of utilizing the smaller Muller support ring in cases of extensive acetabular defects. In series ranging in size from 25 to 56 cases, they reported a high rate of implant migration with up to 44% (25 of 56 cases) after an average follow-up period ranging between 7.2 and 8 years postoperatively. The authors attributed this to the design limitations of the smaller Muller support ring. Since the Muller device is only xated to the ilium and is not buttressed by the inferior pelvic bone, its use should not be extended beyond smaller defects in the acetabular roof, anterior or posterior column, or isolated cavitary defects. Therefore, careful preoperative and intraoperative analysis of the defect using a classication system becomes essential as well as the correct evaluation and implant selection of the specic acetabular pathoanatomy. A comparison of the complications encountered in hip reconstruction using an acetabular support ring is extremely difcult because similar studies list intraoperative and postoperative complications either incompletely, unsystematically, or not at all. In our study, no patient experienced any neurovascular complications, and none of the general postoperative complications encountered led to any permanent damage. Regarding the local postoperative complications that took place in our patients, infection, in particular, warrants mention. One patient experienced a serious infection, which was fortunately treated without removal of the implant. Only one dislocation was observed in 38 cases. We attribute the low dislocation rate to our usage of the lateral approach and a strict rehabilitation program. Nevertheless, we were concerned by the occurrence of six

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hematomas, three of which required surgical drainage. Although we consider this a rather high rate, we need to take into consideration the rather extensive procedures which we are dealing with. None of the patients showed any signicant measurable migration or displacement of the acetabular component. A comparison of the literature revealed rates of Schneider-Burch support ring loosening of up to 12% with an average follow-up period of 5 years [1,21,23]. In all patients within our study group, bony consolidation, according to the criteria described by Azuma et al. [36], Kondo and Nagaya [37], and Morsi et al. [38], occurred entirely within the grafted area. Rosson and Schatzker [44] pointed out the importance of bone grafting over bone cementing after analyzing 66 acetabular reconstructions performed with either the Muller ring (n 46) or the Schneider-Burch ring (n 20). Peters et al. [25] reported impressive restoration of the acetabulum in a group of 28 patients who underwent acetabular reconstruction with a SchneiderBurch ring and allogenic cancellous bone graft. They noted that the average medial wall bone stock improved signicantly from 1.9 mm before surgery to 10.1 mm postrevision ( p , 0.01, two-sample Students t-test, assuming unequal sample variances). The average follow-up period for this study was 2.8 years. In 1999, Paprosky and Sekundiak [18] stated that the role of the acetabular reconstruction cages should, at present, only be dened as a short-term treatment and that follow-up studies still need to be performed in order to determine the worthiness of this procedure. Surprisingly, they only listed three references to support their view. At least 17 studies were published between 1984 and 2001 concerning the role of the acetabular rings with an average follow-up time period of 9.4 years [1,20 25,28,30,31,41 44,47 49,50] (Table 1). Furthermore, they proposed that the use of an acetabular reconstruction ring should be considered not as an alternative but rather as an adjunctive procedure. Contrarily, our results [50] and results of the other mentioned similar studies indicate that the use of an acetabular reconstruction ring with morselized cryopreserved allograft cancellous bone can be considered as a reliable, established procedure that is able to handle massive acetabular deciencies. Paprosky and Sekundiak [18] concluded that allogenic bone grafts provide only osteoconductive potential. Several authors [21,23 25,30] have stated that the autograft and morselized cryopreserved allograft are of equal value in reconstructing acetabular defects. Even Slooff et al. [32], who have a different approach in restoring decient acetabulae, noted that autograft and deep-frozen allograft bone chips are equally effective. They were among the rst to use this method and popularize it. Gross et al. [29] reported successful results using morselized, deep-frozen, and irradiated allograft bone in the treatment of acetabular defects. Herr et al. [51] were able to show in their experimental studies that the cryopreservation of cancellous allografts at 2808C preserved the

316

Table 1 Number 1 3 yr n.s. n.s. n.s. Harris Avg. 19 mo Avg. 5 yr Avg. 30 mo Avg. 5 yr n.s. n.s. Mayo Clinic Harris Harris Cancellous graft Complications Follow-up period Score

Comparison of Literature on Acetabular Reconstruction with Reinforcement Rings, 19842001 X-ray/ bonegraft Ref. 21 30 20 28 31 41 1 24 Winter 44

Year

Support ring

1984

1986 37 145 5 24 42 30 46 20

20 5 18 1 7 yr (avg. 30 mo) Avg. 1.5 yr Avg. 7.7 yr

Only a few allografts All allograft

1988

1989

MR BSR Kerboull ring Freeman ring MR

1989

Gross ring

1991

BSR

1992

BSR

1992

MR

1992

MR BSR

1 M-ring loosened No infection, no loosening All allograft 2 asymptomatic loosening Allograft in 61 4.8% infection, patients 0.7% loosening All allograft No infection, no loosening Autograft bone 2 infections, 1 substitutes loosened ring 20 allografts 12% infection, 12% loosening n.s. No infection, no loosening 33 allografts, 8 No infection, 5 autografts MR loosened

All grafts integrated All grafts integrated All grafts integrated Good experience (n.s.) All grafts integrated Positive experience (n.s.) All grafts integrated Very positive (n.s.) All grafts integrated

1993 43 56 28 16 All morselized allograft 42 autografts 38 allografts IDES 4 IDES 4 Avg. 6.8 yr All allografts Avg. 33 mo All allografts Avg. 7.2 yr No BTx Avg. 8 yr M.d.A.

MR

150

67 allografts

Avg. 7 yr

M.d.A.

49 47 43 25 42

1993

MR

7.3% infection, 9% loosening 3 loosened rings

1994

MR

All grafts integrated 25 increasing radio-lucencies

1995

BSR

Modif. M.d.A. n.s.

Acetabular Bone Impaction

1996

BSR

14% infection, 44% migration No infection, no loosening

1998 63

MR

87

22 23

1998

BSR

6% infection, Avg. 9.4 yr 3% loosening 1% infection, 3% Avg. 8.5 yr loosening, 2% migration 1 infection, no loosening Avg. 7.3 yr

2001

BSR

38

All allografts

Johnston [34] and Harris

Bone stock improved (n.s.) Overall success rate of morselized grafting was 90% All bone grafts had fully healed 37 of 38 allograft had radiological evidence of full incorp. All allografts successful

50

MR, Muller ring; BSR, Burch-Schneider ring; n.s., not specied; M.d.A., Merle dAubigne.

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osteoinductive bone morphogenic protein isotypes. Recently, a [18F]uoride ion positron-emission tomography (PET) study conducted at our institution veried the presence of bone metabolism in areas of allogenic cryopreserved morselized bone grafts even years after hip revision arthroplasty, which clearly indicated intact bone perfusion and vitality in allografted areas [52,53]. In summary, acetabular reconstruction using allogenic morselized cryopreserved cancellous bone grafts and an acetabular support ring with xation at the ilium and ischium appears to be an important method in managing massive acetabular deciencies and can be highly successful in restoring vital bone stock. It is clear that longer-term evaluation will need to take place in order to obtain a better assessment of this procedure.

REFERENCES
1. 2. 3. 4. Berry DJ, Muller ME. Revision arthroplasty using an antiprotrusio cage for massive acetabular bone deciency. J Bone Joint Surg 1992; 74-A:711 715. Maloney WJ, Smith RL. Periprosthetic osteolysis in total hip arthroplasty:the role of particulate wear debris. J Bone Joint Surg 1995; 77-A:1448 1461. Muller ME. Actebular revision. In: The Hip: Proceedings of the Ninth Open Scientic Meeting of the Hip Society. St. Louis: CV Mosby, 1981:46 56. Willert HG, Bertram H, Buchhorn GH. Osteolysis in alloarthroplasty of the hip. The role of ultra-high molecular weight polyethylene wear particles. Clin Orthop 1990; 258:95 107. Wroblewski BM. Probleme der Prothesenlockerung an der Hufte. Orthopade 1989; 18:388 396. Dorr LD, Wan Z. Ten years of experience with porous acetabular components for revision surgery. Clin Orthop 1995; 319:191 200. Lachiewicz PF, Hussamy OD. Revision of the acetabulum without cement with use of the Harris-Galante porous-coated implant. Two to eight-year results. J Bone Joint Surg 1994; 76-A:1834 1839. Silverton DD, Rosenberg AG, Sheinkop MB, Kull LR, Galante JO. Revision of the acetabular component without cement after total hip arthroplasty. A follow-up note regarding results at seven to eleven years. J Bone Joint Surg 1996; 78-A:1366 1370. Tanzer M, Drucker D, Jasty M, McDonald M, Harris WH. Revision of the acetabular component with an uncemented Harris-Galante porous-coated prosthesis. J Bone Joint Surg 1992; 74-A:987 994. Woolson ST, Adamson GJ. Acetabular revision using a bone ingrowth total hip component in patients who have acetabular bone stock deciency. J Arthroplasty 1996; 11:661 667. Dearborn, JT, Harris WH. High placement of an acetabular component inserted without cement in a revision total hip arthroplasty. J Bone Joint Surg 1999; 81-A:469 480.

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Winter E, Piert M, Volkmann R, Maurer F, Eingartner C, Weise K, Weller S. Allogeneic cancellous bone graft and a Burch-Schneider ring for acetabular reconstruction in revision hip arthroplasty. J Bone Joint Surg 2001; 83-A:862 867. Herr G, Schmid U, Holz G, Reutter K, Schnettler, R. Einuss verschiedener Desinfektions- und Sterilisationsverfahren auf die biologische Aktivitat und Struktur von Knochengewebe. In: Schnettler R, Markgraf E, eds. Knochenersatzmaterialien und Wachstumsfaktoren. Stuttgart: Thieme, 1997:78 84. Piert M, Zittel TT, Machulla HJ, Becker GA, Jahn M, Maier G, Bares R, Becker HD. Blood ow measurements with [15OH]H2O and [18F]uoride ion PET in porcine vertebrae. J Bone Mineral Res 1998; 13:1328 1336. Piert M, Winter E, Becker GA, Bilger K, Machulla HJ, Muller-Schauenburg W, Bares R, Becker HD. Allogenic bone graft viability after hip revision arthroplasty by dynamic 18 F uoride ion positron emission tomography. Eur J Nucl Med 1999; 26:615 624.

23
Impaction Bone Grafting on the Femoral Side
A. J. Timperley, P. Kenny, and G. A. Gie
Princess Elizabeth Orthopaedic Centre, Royal Devon and Exeter Hospital Exeter, United Kingdom

I.

THE EXETER TECHNIQUEINDICATIONS

Femoral impaction grafting may be indicated in any patient with pain and functional disability or asymptomatic bone loss secondary to a loose total hip arthroplasty. The technique is most useful in the younger patient, especially in those cases where bone stock is signicantly compromised or where the host bone surface interface will not allow satisfactory mechanical xation of an implant. It may not be indicated in the very old or in medically unt patients where it is possible to achieve distal xation, especially if extensive proximal reconstruction of the femur would be required for the impaction grafting technique.

II. A.

PREOPERATIVE PLANNING Exclusion of Infection

Screening of patients for infection is carried out along conventional lines. Patients have inammatory markers tested such as CRP and ESR. Where there is a clinical suspicion of infection, aspiration of the joint is carried out prior to the denitive surgery. If the infection is proven, or where there remains a high index of suspicion for infection, then a two-stage procedure is carried out with appropriate use of high-dosage antibiotics in cement spacers at the rst stage. Antibiotics are added to the graft at the subsequent impaction grafting procedure [1].
323

324

Timperley et al.

B.

Analysis of Bone Deciencies

The preoperative x-rays should be analyzed in order to estimate the amount of bone stock loss in the femur. In addition to an A-P view showing the whole length of the existing implant, lateral x-rays are also required to detect anterior and posterior femoral deciencies. An estimation of the amount of bone necessary for the procedure is made and a number of femoral heads or strut grafts booked with a bone bank accordingly. It is usually possible to predict if any of the X-change wire meshes will be necessary to reconstruct the femoral tube, although these meshes should be readily available in the operating theatre in case they are unexpectedly required intraoperatively. C. Templating

A-P and lateral lms should include the whole of the femoral component and should extend distally (down to normal femur) beyond the femoral defects. From these lms we determine the position and size of the distal plug. The plug will be placed at least 2 cm beyond the stem tip or 2 cm below the most distal lytic area in the femur, whichever is the more distal. The X-change plug template is used to conrm the position of the plug and to determine the distance of the plug from the tip of the greater trochanter. This will ensure that the plug is placed at the correct position during the surgery by use of the corresponding calibrations on the guide wire. The stem length, the offset, and the stem size of the Exeter femoral component to be implanted are estimated by using the preoperative template. The system of X-change instruments allows for implants ranging in offset from 30 to 44 mm. In addition it is possible to implant the smaller 50 offset stems into the neo-medullary canal created by the 44 mm offset phantoms. Stem lengths up to 260 mm are available (Fig. 1). The nal stem offset and size is decided upon intraoperatively. Long stems should be considered in cases where a fracture is present, where there is poor quality bone stock in the femur at a level corresponding to the stem tip of a conventional length stem, or for the reasons discussed in Sec. X in cases of Endoklinik 3 and 4 bone stock loss.

III.

POSITIONING THE PATIENT

The patient is positioned by the operating surgeon on his or her side in the lateral decubitus position. This position will allow, if necessary, exposure of the posterior, lateral, and anterior aspects of the hip joint and pelvis by modications to the approach. The patient is supported securely with a sacral pad and support pads on the anterior superior iliac spines (Figs. 2, 3). The patient is draped so that

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Figure 1 Stem range: Longer stems up to 260 mm in length are available with instruments to facilitate graft packing.

the incision can be extended up to the posterior superior iliac spine and down as far as the knee when necessary. IV. A. SURGICAL APPROACH Incision

We use a long postero-lateral incision incorporating or excising the previous scar, if possible. However, if the patient has previously had an antero-lateral approach or the old scar is unsuitable, then a new incision is made.

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Figure 2

Positioning: The patient is positioned securely on the operating table.

B.

Fascial Incision

The incision should begin through an area of fascia lata that has not been involved in previous exposures. This allows the development of the subfascial plane and the identication of a good fascial layer, which is important for closure. The tendinous part of the gluteus maximus is exposed at its insertion, and approximately two thirds of this divided. C. Identication of the Sciatic Nerve

The sciatic nerve is identied, although we do not nd it necessary to expose the nerve throughout the surgical eld unless the posterior column of the pelvis is

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Figure 3 View of pelvis clamps.

decient and requires augmentation. The nerve is protected by a ap of capsular tissue, which is retracted posteriorly. D. Identication of Landmarks

The ischium, sciatic notch, gluteus medius tendon, the posterior border of gluteus minimus, and the ilium superior and posterior to the socket should be identied. E. Aspiration of the Hip

At this stage a needle is passed through the capsule into the hip joint and uid is sent routinely for Gram stain and microscopy. Should there be an excessive

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number of neutrophils or if organisms are identied, the procedure should be abandoned in favor of a two-stage procedure. Frozen section of multiple tissue samples may be useful if there remains any doubt about the possibility of the joint being infected [2]. F. Capsular Exposure and Incision

The capsule and remnants of the external rotators are incised with cutting diathermy along their attachments to the posterior aspects of the trochanter and the trochanteric ridge. They are reected as a ap backwards from the femur, the proximal margin of the ap running along the lower border of gluteus minimus to the posterior margin of the acetabulum, and the distal margin being the posterior inferior aspect of the capsule extending down towards the transverse ligament. Stay sutures are then placed in these tissues, and these can be used to hold the capsular ap posteriorly also protecting the nerve. Where the capsule is very thick and scarred, it is partially excised. At the end of the procedure, the capsular ap is reattached to the posterior aspect of the femur. The psoas tendon is usually released from the lesser trochanter, and, using sharp dissection or diathermy, the anterior capsule is released from the anterior aspect of the femur on the femoral neck. It is important to carry out this release before the leg is signicantly exed and internally rotated since the anterior wall of the femur is often imsy and may fracture and tear off during dislocation of the joint. G. Dislocation

After mobilization of the posterior capsule, the head of the prosthesis is visible and a bone hook is passed around the neck of the prosthesis to aid dislocation. The femur should not be rotated during dislocation as this may cause fracture. Further scar tissue is released from the anterior femoral neck as necessary. H. Removal of the Femoral Component

Considerable soft tissue dissection may be needed to remove the femoral component safely. Cement is removed from over the shoulder of the prosthesis using a high-speed burr. The tissue and cement around the proximal part of the femoral component should be released and removed. The femoral component is then knocked out gently. Vigorous attempts to extract the component may fracture the femur. If the femoral component cannot be removed without the use of excessive force then an extended trochanteric osteotomy is performed [3]. This maneuver does not preclude the impaction grafting. When the time comes for reconstruction of the femur an X-change femoral phantom that bypasses the

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distal osteotomy cut is seated down the femur to the correct level and the osteotomy is reduced and held with Dall-Miles cables. It is usually necessary to excavate some of the bone from the greater trochanter to allow the osteotomized fragment to be reduced adequately (see below).

I.

Further Mobilization of the Femur

It is essential to achieve adequate mobilization and delivery of the proximal femur. The proximal part of the greater trochanter must be exposed sufciently to allow insertion of the guide wire down the medullary canal in the midline axis of the canal so that the neo-medullary canal that is subsequently formed by the use of the femoral phantoms is in neutral alignment down the femur, and not in either varus or valgus. The width of these instruments dictates that the proximal aspect of the trochanter must be opened approximately 1 cm lateral to the midline axis of the canal (Fig. 4). The lateral margin of the proximal opening lies anterior to the gluteus medius tendon and posterior to gluteus minimus and may extend over the lateral side of the tip of the trochanter.

V.

PREPARATION OF THE GRAFT

In Exeter we use almost exclusively allograft from fresh frozen femoral heads from our own bone bank, but, if available, distal femoral condyles are an excellent source of cancellous bone. The Exeter Bone Bank complies with the standards and procedures as required by the British Association for Tissue Banking [4]. ABO compatibility between graft donor and recipient is not necessary. Rhesus compatibility is important when the patient is a rhesusnegative woman of child-bearing age. Donors are screened for transmissible diseases and are rescreened 6 months after donation. Should all tests remain negative, then the femoral head is released for use as allograft. The allograft chips are prepared by passing the femoral heads through a bone mill. All cartilage and soft tissue must be removed from the femoral heads prior to milling. The mill allows two sizes of chips to be made. The smaller chips, 2 4 mm in size, are used in the distal canal. Larger chips are used in the proximal femur. In canals that are very capacious proximally, hand-made croutons 10 mm in size will be mixed with smaller chips and are packed in around the seated phantom. Bone slurry is not a suitable material for adequate compaction. The ideal material is pure cancellous fragments or cortico-cancellous chips; thick cortical fragments from the calcar area of the head should be removed. At least two

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Figure 4 Guide wire in place: The trochanter must be opened laterally far enough to allow the guide wire to lie in a neutral position.

femoral heads should be available for each casemore if this is predetermined by the preoperative x-ray examination or if the acetabulum also requires grafting.

VI. A.

PREPARATION OF THE FEMUR Removal of Cement from Previous Prosthesis

Cement removal must be complete in the area for impaction grafting. However, if the distal cement plug is greater than 2 cm beyond the most distal lytic area of the femur, is solidly xed, and if there is denitely no infection, it may be left in position and used to occlude the distal canal.

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B.

Removal of All Granulomatous Tissue and Fibrous Membrane

This material should also be thoroughly removed, followed by copious irrigation of the canal. Six separate specimens of tissue and membrane from the interfaces are routinely sent for microbiological examination. C. Repair of Diaphyseal Defects in the Femur

The success of impaction grafting as a revision technique depends on adequate physical constraint for the graft. Therefore, defects in the femur must be reconstructed prior to impaction grafting. In Exeter we use malleable meshes (Stryker Howmedica, Benoist-Girard, France) and monolament cerclage wires to reconstruct diaphyseal defects after reecting vastus lateralis anteriorly to expose the femur. More proximal defects are reconstructed later in the procedure (see below). D. Prophylactic Cerclage Wire of the Femur

Prophylactic cerclage wiring is recommended where there is poor-quality bone in the proximal femur or if there is any evidence of splitting of cortical bone. Vigorous packing during impaction grafting may cause intraoperative femoral fracture or extension of a crack if wiring has not been carried out. E. Distal Occlusion of the Femur

Prior to grafting, the distal femur must be occluded in order to constrain the graft. Most often a new threaded intramedullary X-change plug is used. The threaded intramedullary plug is screwed onto a guide rod, and the plug-introducer sleeve is passed over this rod. The guide rod introducer is then assembled onto the slaphammer assembly and the plug is impacted to the level previously templated. The depth of the plug should be at least 2 cm distal to the implant that has been chosen. For example, with the standard implant the plug must be to a depth of at least 19.5 cm from the tip of the trochanter, and with a 220 mm implant the plug must be at least 240 mm. Occasionally there is a suitable cement plug, which may be left in situ. If this cement plug is to be used, then the largest distal impactor that will t down the canal is introduced down to the level of the plug, and this acts as a drill centraliser. The intra-medullary drill is passed through the impactor and the cement drilled to a depth of approximately 6 mm. The guide rod can then be passed through the impactor and screwed into the predrilled hole in the cement plug. If lysis extends beyond the isthmus and there is no suitable preexisting plug, then the canal may be occluded with bone cement. This is achieved by using

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a small bolus of viscous cement delivered to the correct level. When the cement has polymerized, the largest plug that will pass through the isthmus should be placed on top of the newly formed distal cement plug. An alternative method is to introduce the largest plug that passes through the isthmus down to the correct depth and then prevent it from migrating distally by introducing one or two K-wires percutaneously at a level just below the plug. The instruments now used to pack the graft in the distal femur and in the proximal femur are cannulated and pass over the guide wire (Fig. 5).

Figure 5 Distal packers and proximal phantom: The instruments used to pack the graft are all cannulated and pass over the guide wire.

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F.

Aligning the Instruments in a Neutral Position

The impactor sleeve is removed, and the proximal impactor or phantom of the size previously templated is passed over the rod to ensure that it will t down to the appropriate level to restore leg length. The correct size of phantom is decided at this point. The proximal packer chosen should pass easily down the guide wire without hitch to a depth well below the level required to restore the correct leg length. Care should be taken that the rod is not driven into varus as the impactor is inserted. If this occurs, further development of the postero-lateral slot in the trochanter is necessary until neutral alignment of the proximal impactor can be achieved. Neutral alignment is best checked by reference to the middle of the popliteal space. The guide wire should lie freely in the canal proximally, and it should point to the midpoint of the popliteal fossa when viewed from its proximal end (Fig. 6).

VII. A.

IMPACTION OF THE GRAFT Distal Packing

Before using the distal impactors to impact the bone chips, it is important to establish the distance down the canal that each size of impactor can be passed without jamming in the canal. Any attempt to hammer the impactor further than this point will inevitably lead to a fracture. The impactor that corresponds to one size smaller than the intramedullary plug should pass over the guide wire down to the plug without obstruction. Each larger-diameter impactor in turn is introduced as far down the canal as it will pass, and a small rubber ring is snapped onto its shaft at the level of the tip of the greater trochanter (Fig. 7). Subsequently, when impacting the bone chips, do not drive the impactor beyond this depth. Ensure that the plug is tight and not migrating down the canal; if the plug migrates, the calibration on the guide wire opposite the tip of the trochanter will move. The assistant should be given the task of checking the mark after each instrument is passed. If the plug is migrating, it can be transxed at the correct depth with a K-wire. The allograft chips are introduced around the guide rod using a 10 mL syringe which has had the end sawn off. The chips are then pushed down the canal using the larger impactors. The impactor that corresponds to the diameter that will pass right down to the plug is then introduced over the guide rod and chips are compacted down onto the distal plug. A depth of 10 15 mm is established by hand-packing. The impactor should then be connected to the slap hammer for further impaction.

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Figure 6 Alignment of instruments: The guide wire should point to the middle of the popliteal fossa when viewed down its length.

The impaction process is continued by introducing and impacting more chips and using progressively larger impactors. The distal impaction is continued until the level of the chips is up to the level of the distal impaction line. This corresponds to the depth down the femur of the proximal phantom and is indicated by the beginning of an area of polishing on the shaft of the distal packers (Fig. 7). At this point the proximal impactors or phantoms should be used. It is important not to pack chips beyond the distal impaction line or it may prove impossible to introduce the phantom. If this occurs it may be possible to introduce a smaller phantom to cut into the distal bone plug, although more often

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Figure 7 Markers on distal packers: An indicator is snapped onto each distal packer to indicate how far down the canal it can be used.

some of the distal graft will have to be removedeither with the use of a long curette or by using the corer from the long-stem instruments.

B.

Packing with the Proximal Phantoms

The appropriate proximal impactor or phantom is mounted on the slap hammer assembly and threaded over the guide rod. Using the slap hammer, the phantom is driven into the distal bone plug. This forces the distal graft against the wall of the canal. The handle is used to ensure that the neo-medullary canal so formed is in

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the correct amount of anteversionusually 10 15 degrees. More graft is introduced (approximately 5 cc at a time), and the distal packers are used by hand to compact the chips onto the graft distally. The proximal impactor is repetitively driven into the distal impacted graft using the slap hammer in a vigorous fashion. When the canal has been lled almost to the top, a trial reduction of the femur may be carried out, leaving the guide rod in position (Fig. 8). The level to which the femoral component should be inserted can be determined from this trial reduction and an appropriate mark made on the femoral neck to indicate the depth of insertion of the implant (Fig. 9).

Figure 8 place.

Trial reduction: A trial reduction is carried out, leaving the guide wire in

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Figure 9 Leg length mark: A mark is made on the surface of the femoral neck adjacent to one of the marks on the stem.

An assessment of stability and the range of movement can also be established. If there is impingement, then further excision of soft tissue or bone may be required. A stem of larger offset may occasionally be indicated.

C.

Proximal Reconstruction of the Femur

One should also at this stage assess the need for reconstruction of the proximal femur. If there is decient bone in the proximal femur, reconstruction should now be carried out with the phantom seated to the correct depth. The femur requires

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augmentation if there is loss of bone below the level of the lesser trochanter on any aspect. The reconstruction should be up to a level that corresponds to one of the three marks on the phantom (and therefore on the implant). The stem must be supported up to this level in order that it is torsionally stable within the femur. Proximal reconstruction is achieved with the use of malleable wire mesh and monolament wires. If the loss of proximal bone in the calcar area is modest, the acetabular rim meshes are very useful and may be applied over the decient area and held with monolament wires (Fig. 10). The preferred method to apply these wires is as follows: a drill hole is made through the trochanter as far laterally as possible halfway between the tip of the greater trochanter and the level of the lesser trochanter. Both cortices are drilled and the wire passed through the anterior edge of the wire mesh. The wire is further threaded through

Figure 10 Rim mesh: The acetabular rim mesh can be wrapped around the proximal femur to reconstruct the calcar region.

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the posterior edge of the mesh and then tightened to itself. This xed wire prevents the mesh moving up or down on the femur. A second wire is passed around the femur beneath vastus lateralis just below the lesser trochanter, threaded through a hole in the mesh, and tightened to itself. Occasionally a third wire is necessary. For larger defects an anatomical calcar mesh is available (Figs. 11, 12). This is applied in a similar fashion to the smaller mesh. Cables may

Figure 11 Calcar mesh: An anatomic shaped calcar mesh can be used to reconstruct larger deciencies in the proximal femur.

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Figure 12 X-rays of calcar mesh: Calcar mesh applied with monolament wires proximally and Dall-Miles cables distally.

be used around this mesh distally. These are usually avoided more proximally because of a fear of the cable fretting as it passes through the mesh.

D.

Proximal Packing of Graft

Having reconstructed the proximal femur, the phantom is withdrawn from over the guide rod, more bone chips are inserted, and then they are impacted, initially using

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the hand-held distal impactors and then using the proximal phantom impactor. The proximal impactor should now be getting tight within the canal. From now on, alternate the proximal phantom impactor and the distal impactors, packing in more bone chips at each stage. With the proximal phantom impactor partially withdrawn, a nal proximal packing is achieved using the hand-held impactors (Fig. 13). The proximal impactor is again used to impact this proximal bone. If the graft is so tight that the proximal impactor cannot be introduced fully, use one size smaller for nal impaction. Select the stem size on the basis of the size of the proximal phantom impactor that is used for the nal packing. Absolute axial and

Figure 13 Hand-packing of graft: Larger bone chips are packed around the seated femoral phantom.

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torsional stability of the phantom should be evident at the conclusion of impaction. It should be very difcult to withdraw the phantom at the end of impaction grafting and impossible to achieve removal without the use of the slap-hammer. E. Cementation and Stem Insertion

At this stage the graft is ready for insertion of the denitive prosthesis. The guide wire is unscrewed, leaving the phantom in position until just before cement

Figure 14 Neomedullary canal: Removal of the stem phantom reveals the neomedullary canal.

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insertion. This keeps the graft compressed, and the canal can be sucked dry by placing a catheter down the lumen of the phantom. After removal of the phantom (Fig. 14), antibiotic Simplex cement is introduced in retrograde fashion using the revision cement gun with a tapered gun spout. Once the canal has been lled, the nozzle is cut ush with the femoral seal and the cement is then pressurized into the graft (Fig. 15). Pressurization is maintained until the viscosity of the cement is appropriate for stem insertionnormally about 5 minutes after mixing if the operating room temperature is 208C. A wingless Exeter stem centralizer is tted to the end of the

Figure 15 Cement pressurization: Cement is injected with a gun through the proximal femoral seal to pressurize the cement into the graft.

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prosthesis prior to insertion. The stem is then inserted to its predetermined position. Attention must be paid to the alignment of the stem during insertion. The surgeon uses his thumb to occlude the exit from the medullary canal and thus maintain pressure on the medial cement throughout insertion (Fig. 16). When the desired position of the prosthesis is achieved, the stem introducer is removed and a proximal seal is applied around the proximal stem in order to maintain pressure on the cement and graft while the cement polymerizes (Fig. 17). Trial reduction is then carried out using one or more of the 4 mm, 0, or 24 mm heads, and the appropriate one selected after testing for leg length, range of motion, and stability (Fig. 18).

Figure 16

Stem insertion: The stem is introduced into the neomedullary canal.

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Figure 17 Horsecollar: The sorbothane horsecollar is applied around the implant and pressure applied onto the graft and cement.

Figure 18

Trial reduction: Final trial reduction before closure of external rotators.

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VIII.

REDUCTION AND CLOSURE

The hip is reduced. The posterior capsule is reattached via drill holes to the posterior aspect of the femur. The wound is closed over a single deep drain.

IX.

POSTOPERATIVE MANAGEMENT

The drain is removed and patients are mobilized on the rst or second day postoperatively. Touch weight bearing is advised in most patients for at least the rst 6 weeks, at which point they are re-x-rayed. If there is less than 1 mm of migration of the stem within the cement mantle, they are allowed to take more weight through the limb building up to full weight bearing by 12 weeks. In the elderly, full weight bearing is permitted.

X.

LESSONS WE HAVE LEARNED DURING EVOLUTION OF THE TECHNIQUE

The results of impaction grafting at our center have generally been good with regard to the clinical outcome scores for patients, survivorship of the implants, and the radiological feature of restoration of bone stock. As a result of the optimistic results in the early group of patients who underwent this procedure [5], dedicated instruments were developed to help make the procedure more reproducible and to facilitate graft compaction. A greater number of patients with severe bone stock loss have been operated on since the original group, and the risk factors for the two principal complications for the impaction grafting procedurefemoral fracture and signicant subsidence of the stem within the cement mantlehave become evident. In a series of 225 consecutive cases of femoral impaction grafting carried out by multiple surgeons at the Orthopaedic Hospital in Exeter, there were 10 cases of femoral shaft fracture, in 5 of which an unrecognized fracture had occurred during the operation. It is therefore important to recognize and adequately x a fracture that occurs intraoperatively, and a long stem to bypass the area is generally advocated. We now also use longer stems to bypass weakened or defective areas of bone since they are at increased risk of postoperative fracture. Occasionally, strut grafts or plates are used in addition to the longer stem. Dedicated instruments have been developed to allow bone to be packed around these long stems. The other complication that has been reported in the literature is that of massive subsidence of the stem within the canal [6 10]. Subsidence of the stem within the cement mantle over 10 mm occurred in 14 cases in our series.

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Subsidence of this degree did not lead to a deterioration in the clinical scores of these patients, but movement of this degree is best avoided if possible. We found that the patients most at risk for signicant subsidence were those with severe bone stock loss (Endoklinik 3 and 4). The incidence of signicant subsidence has now been reduced by a number of measures, including the use of larger bone chips in capacious canals, a better distribution of particle size [11,12], tighter compaction of these chips within the femoral canal [11,13 16], and, in the case of severe bone stock loss, the use of longer stems. In revision surgery the technique of impaction grafting has an advantage over other forms of femoral reconstruction in that it holds the potential for augmentation of bone stock in decient femora as the compacted allograft chips are incorporated and subsequently remodeled in the host skeleton. The potential problems associated with the technique are becoming clearer, as are the indications for its use (see above). Most of the complications reported from centers that have used this technique, including our own, have resulted from inappropriate surgical technique. Application of the methods described in this chapter should further improve the results possible using the impaction grafting method.

REFERENCES
1. English H, Timperley A, Dunlop D, Gie G. Impaction grafting of the femur in two-stage revision for infected total hip replacement. J Bone Joint Surg Br 2002; 84:700 705. Athanasou NA, Pandey R, de Steiger R, Crook D, Smith PM. Diagnosis of infection by frozen section during revision arthroplasty. J Bone Joint Surg Br 1995; 77:28 33. Younger TI, Bradford MS, Magnus RE, Paprosky WG. Extended proximal femoral osteotomy. A new technique for femoral revision arthroplasty. J Arthroplasty 1995; 10:329 338. A code of practice for tissue banks providing tissues of human origin for therapeutic purposes. London: UK Department of Health, 2001. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg Br 1993; 75:14 21. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early subsidence following femoral impaction grafting. J Arthroplasty 1997; 12:535 540. Masterson EL, Masri BA, Duncan CP. The cement mantle in the Exeter impaction allografting technique. A cause for concern. J Arthroplasty 1997; 12:759 764. Jazrawi LM, Della Valle CJ, Kummer FJ, Adler EM, Di Cesare PE. Catastrophic failure of a cemented, collarless, polished, tapered cobalt-chromium femoral stem used with impaction bone-grafting. A report of two cases. J Bone Joint Surg Am 1999; 81:844 847.

2. 3.

4. 5.

6. 7. 8.

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Timperley et al. Meding JB, Ritter MA, Keating EM, Faris PM. Impaction bone-grafting before insertion of a femoral stem with cement in revision total hip arthroplasty. A minimum two-year follow-up study. J Bone Joint Surg Am 1997; 79:1834 1841. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction bone grafting in revision hip surgery. A high incidence of complications. J Bone Joint Surg Br 2000; 82:103 107. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR. Mechanical considerations in impaction bone grafting. J Bone Joint Surg Br 1999; 81:118 124. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength. J Arthroplasty 1999; 14:1019 1023. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem in revisions of the hip using impaction allograft. Evaluation with radiostereometry and dual-energy x-ray absorptiometry. J Bone Joint Surg Br 1999; 81:135 142. Giesen EB, Lamerigts NM, Verdonschot N, Buma P, Schreurs BW, Huiskes R. Mechanical characteristics of impacted morsellised bone grafts used in revision of total hip arthroplasty. J Bone Joint Surg Br 1999; 81:1052 1057. Malkani AL, Voor MJ, Fee KA, Bates CS. Femoral component revision using impacted morsellised cancellous graft. A biomechanical study of implant stability. J Bone Joint Surg Br 1996; 78:973 978. Hostner J, Hultmark P, Karrholm J, Malchau H, Tveit M. Impaction technique and graft treatment in revisions of the femoral component: laboratory studies and clinical validation. J Arthroplasty 2001; 16:76 82.

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24
Impaction Grafting of the Proximal Femur with Freeze-Dried Bone in Revision Arthroplasty
A. Mazhar Tokgozoglu, Bulent Atilla, and Egemen Turhan
Hacettepe University Faculty of Medicine Hacettepe, Ankara, Turkey

I.

INTRODUCTION

From the beginning of total hip replacement there has always been a need for revision for loosening. Loosening causes a signicant amount of bone loss, which must be replaced if the revision hip replacement is to survive over the long term. Restoration of bone stock is a challenge, and various approaches have been suggested. Of these, impaction grafting has been one of the most innovative. Impaction grafting has been used for restoring bone defects in revision total hip arthroplasty since 1979. In 1979 Slooff et al. introduced it for reconstructing contained cavitary bone defects of the acetabulum during revision hip replacement [1]. They used morselized fresh frozen femoral head allografts from their bone bank, which collected femoral heads harvested during primary total hip arthroplasties. The technique proved satisfactory when the acetabular bone defect was cavitary and vigorous impaction was used. Later they were able to extend their indications to segmental defects when the rim was reconstructed with wire mesh. Their 10-year results proved that this biological approach to the management of bone defects caused by acetabular loosening was sound [2]. This experience encouraged Ling and Gie to try impaction grafting for femoral loosening in 1987 [3]. They impacted morselized allograft in the femur after removing the loose stem and interface membrane. Their initial indication was cavitary defects of the proximal femur in revision total hip arthroplasty. Fresh frozen femoral heads from primary total hip arthroplasties were their
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source of cancellous bone. An average of four to six femoral heads were morselized and impacted into the proximal femur. After impaction, a collarless polished double-tapered stem (Exeter, Howmedica, Rutherford, NJ) was implanted using third-generation cementing techniques. The stability achieved in the early stage and early clinical results encouraged them to extend the indications for its use [4] and develop an instrumentation system (X-Change System, Howmedica, Rutherford, NJ) to improve the consistency of their results. Excellent results of this procedure have been reported in the literature [5 12]. Biopsies show that the impacted allograft incorporates and reconstitutes the proximal femur [13 16]. However, the supply of allograft is limited, and disease transmission is a major issue despite rigorous testing [17,18]. Several femoral heads are required for satisfactory impaction, and despite bone from organ donors and routine harvesting of femoral heads, the supply of fresh femoral head allografts does not match the demand of increasing numbers of revisions. There are national and cultural variations in obtaining consent for bone donation. Storage and transport of fresh frozen allograft increases its cost and decreases its availability. To overcome the problems storing and transportating fresh frozen grafts, freeze-drying (lyophilization), widely used in the food industry, was introduced to bone banking. During freeze-drying, water is removed by sublimation from the material after it has been frozen. The bone is then vacuum-packed under sterile conditions and can be stored at room temperature for up to 5 years. Freeze-drying also prevents bacterial growth [19 21]. Although the shelf life can be increased signicantly, some properties of stored bone change with freeze-drying [19,21]. Freeze-drying does not affect the limited osteoinductive properties of allograft bone and decreases its antigenity. While the osteoprogenitor cells are destroyed, the osteoconductive properties of the cancellous and cortical bone are largely retained. The deeply bound, limited osteoinductive material present in the graft may be only partially retained. Moreover, freeze-drying can decrease the mechanical properties of allograft bone with loss of hoop and compressive strength on rehydration [19]. Initially, these concerns prevented the use of freezedried graft for impaction grafting since mechanical strength of the impacted bone is a prerequisite to the technique. However, freeze-dried allografts have been in used in orthopedic surgery with satisfactory results [19,23].

II.

SURGICAL TECHNIQUE

On admission to the hospital for impaction grafting, radiographs of the patient are examined for preoperative planning. Using the templates of the Exeter X-Change Hip Revision System (Howmedica, Rutherford, NJ), the site of the distal restrictor is determined and the approximate volume to be lled with bone is

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estimated. Once the patient is brought in to the operating theater, the estimated amount of freeze-dried allograft is delivered. After surgical exposure and frozen section to exclude infection, the bone is reconstituted in 0.9% physiological saline. This takes between 30 minutes and an hour, during which time the prostheses, cement, and brous membrane are removed. After complete removal of the cement and surrounding osteolytic membrane, a polyethylene bone plug with a guide wire attached is placed in the femoral medullary canal. The estimated amount of allograft needed is checked once more to ensure that the required amount of bone is available. Cortical defects are reconstructed with allograft struts or metal mesh xed with cerclage wire. After insertion of the bone plug, the freeze-dried allograft is impacted into the femoral canal [3]. We recommend impacting the graft as densely as possible to make sure it is really solid. The graft is initially impacted with graft impactors chosen to t the canal diameter. These impactors work over the guide wire attached to the distal restrictor. After the isthmus is lled with graft, tamps shaped like the femoral stem are used. These tamps come in different sizes that match the femoral component. The tamp used is chosen during the preoperative planning with templates. The canal is lled with bone again, and the graft is impacted into the proximal femur. The tamps work over the central guide wire (Fig. 1). Additional

Figure 1 The nal temp is impacted into the proximal femur over the guide wire. The anterior rim of the femoral neck is reconstructed with a metallic mesh.

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bone is packed around the tamp until the proximal femur is completely lled with impacted graft. Then the handle of tamp is twisted with a wrench to ensure rotational stability. If the tamp does not move with twisting, the graft is considered adequate. The tamp also can accommodate provisional femoral heads to carry out a trial reduction and check the stability of the graft. After grafting is complete and trial reduction is satisfactory, an Exeter polished stem (Howmedica, Rutherford, NJ) is cemented in the gap created by the instrumentation using third-generation cementing techniques (Fig. 2).

III.

THE HACETTEPE EXPERIENCE

Since October 1996, we have performed 42 impaction graftings during revision total hip arthroplasty. Of these 42 hips, 33 hips in 32 patients had a complete clinical and radiological follow-up [24]. Our indication for performing these procedures was aseptic loosening of a total hip arthroplasty in patients with cavitary defects of their femora that could not be managed with a fully porous

Figure 2 The nal temp and guide wire are removed from the canal prior to cementation. The quality of bone impaction is visible resembling the cancellous bone of the proximal femur. As the graft is rmly impacted, the position of impacted bones does not change despite removal of the temp.

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coated long cementless femoral component. Using the AAOS classication of femoral defects, 23 of these hips were type 2, and 12 of them were type 3. We followed these patients prospectively, and all of them are currently under review. As of May 2002, our average follow-up is 53 (range 42 68) months (Fig. 3). Only one patient required a revision for deep sepsis following removal of a

Figure 3 One of our cases 3 years after impaction grafting. The reconstitution of bone is visible. There are no subsidence or radiolucent lines at the cement bone interface. Ectatic lateral cortex of the femur has started to heal.

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broken trochanteric wire after 48 months. Other than this, none of our cases are being considered for revision. We impacted either morselized or cancellous cubes of freeze-dried allograft. When the available graft was cancellous cubes, they were morselized with a bone mill. The average amount of bone graft needed was 145 (range 60 270) cc. Cortical defects requiring reconstruction with metal mesh were present in 9 hips. In 4 of the hips, cortical freeze-dried allograft was used to reconstruct cortical defects. Cable wires were used in 15 hips to either x the metal mesh and cortical grafts or to protect the femur from fracturing during and after graft impaction (Fig. 4). In three cases the wires were used to prevent ssure fractures from propagating distally. After surgery the patients were allowed to bear weight within limits of comfort the following day and were encouraged to fully weight bear with crutches before discharge on the seventh postoperative day. All cases were followed up after 6 weeks and 6 months postoperatively and thereafter yearly. All patients were assessed with Harris Hip Scores and radiographs at their latest follow-up. Radiographs were examined for radiolucent lines, subsidence, cement fracture, and cortical and trabecular remodeling of the impacted graft. At the latest follow-up examination, all cases except the infected one had signicantly higher Harris Hip Scores (average preoperative score 55, postoperative 89; p 0.043). Only three patients needed canes to walk because of weak abductors. All patients except the infected one, whose prosthesis had been removed, were free of pain. Five patients had a slight limp. None sustained a postoperative fracture. There was incorporation and remodeling of the impacted freeze-dried allograft in all cases including the infected one. Cortical remodeling took place in ectatic femora. The femoral component subsided in the cement mantle in ve cases by an average of 2 mm (range 1 4 mm). One patient with 3 mm of subsidence also had the only cement mantle fracture. Follow-up radiographs revealed that this cement fracture was stable and the implant was not loose. There were radiolucent lines about 1 mm thick in 17 patients mostly in Gruen zones 1 and 7. Trabecular remodeling was seen to some extent in all patients (Fig. 5). A patient with severe rheumatoid arthritis was revised for a painful hemiarthroplasty with protrusio. During the revision with impaction grafting, a trochanteric osteotomy was needed to expose the centrally displaced femoral head. This was xed with a cable grip, the wire of which broke 24 months postoperatively, causing a painful trochanteric bursitis. After removal of the wire, the patient developed a wound infection that was initially treated with antibiotics. However, the infection became deep, an initial attempt at antibiotic suppression with retention of the prosthesis failed, and 50 months after the impaction grafting the prosthesis was removed and an antibiotic impregnated cement spacer inserted.

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Figure 4 One of the cases that needed metallic mesh and cable wire xation. This case is 54 months after the impaction grafting. There is evidence of radiolucent lines, or subsidence. The impacted graft has remodeled.

IV.

SCINTIGRAPHIC STUDY

As none of our patients other than the infected case required revision, we wished to assess the biological activity in the bone mass after impaction grafting and tried bone scintigraphy in a group of patients. To overcome the

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Figure 5 New trabeculae formation and reconstitution of the cortex are clearly visible 48 months after impaction grafting.

problem of superimposition of the anterior and posterior aspects of the stem, we used the single photon emission computed tomography (SPECT) technique to determine revascularization and new bone formation in the impacted bone graft surrounding the femoral stem. Nine patients who underwent impaction grafting with at least 1- to 2-year follow-up were included in this study [25].

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These patients underwent a Tc-99m MDP bone scintigraphy using SPECT, and all demonstrated increased uptake indicating new bone formation in the impacted freeze-dried graft. This indicated that signicant revascularization, remodeling, and new bone formation were still occurring up to 2 years after impaction grafting (Fig. 6).

Figure 6 One of the patients in the group that was examined with scintigraphy. The area corresponding to the impacted graft demonstrates a signicant uptake of radioisotope both in the coronal and transverse slices of the SPECT study. This indicates the intense new bone formation within the graft mass.

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V.

DISCUSSION

When revising a loosened total hip arthroplasty, the aim is to reconstruct the articial joint. This can be done with either an implant or bone. As soon as a new hip replacement is implanted, the loosening process and loss of bone stock starts again, so the loose joint replacement should preferably be reconstructed with bone. By restoring bone stock with impaction grafting, further revisions should be easier. Impaction grafting is a proven method of reconstructing defective femoral bone stock after removal of an aseptically loose total hip arthroplasty. Impacting cavitary defects with bone graft is traditional practice in benign tumors and trauma. In impaction grafting the same principle is applied; the defective femur is grafted with bone and the graft is internally xed with a cemented femoral stem. The stem recommended for this purpose is the Exeter (Howmedica, Rutherford, NJ). It has a double taper with a polished surface that subsides within the cement mantle, compressing the remodeling bone. As the cement mantle expands with creep, the stem can subside within the cement mantle maintaining the integrity of the cement bone interface [26,27]. Freeze-dried allografts have been used for different indications in orthopedic surgery [22,23]. Freeze-dried allografts are effective llers and a good scaffold for osteoconduction [21]. However, because freeze-drying impairs the compressive strength of bone, it was considered unsuitable for impaction grafting. A major advantage of freeze-dried allograft is its availability and the much lower risk of disease transmission. Fresh frozen grafts obtained from femoral heads are easy to collect but difcult to test for safety and store. Fresh frozen femoral heads collected during total hip arthroplasty vary in quality, quantity, and shape [28,30]. Femoral heads are usually collected from patients with osteoarthritis, which reduces the amount of cancellous bone and consequently their osteoinductive and osteoconductive properties. Because of this, we decided to try freeze-dried cancellous allograft for impaction grafting as it was readily available and is reliable in terms of disease transmission and quantity. Three major problems following impaction grafting have been reported and are major concerns in impaction grafting. The rst is femoral fracture [9,11], usually caused by stems that are too short to bypass lytic lesions. We addressed this problem by lling the cavity with bone and bypassing the lowest defect by 3 cm or supporting the cortex with strut allografts. There have been no postoperative femoral fractures. However, we had three intraoperative femoral fractures during graft impaction. These were managed with cerclage wiring, and whenever we suspected that the underlying bone was weak, we prophylactically xed the femur with wires. The second problem has been rapid loosening and signicant subsidence of the femoral component [11]. Initially when the instrumentation was designed, the

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tamps were designed to create a void just large enough for the femoral component. This did not allow sufcient space for an adequate cement mantle, and rapid failure ensued [30,31]. We overcame this by using a 2 mm oversized tamp before cementing. The new instrumentation is oversized by 2 mm to address this. The third problem is inadequate graft impaction. If grafts are not impacted adequately, the nal construct fails early. We addressed this by impacting the tamps into the graft until we could no longer twist them with a wrench attached to the tamp handle. For consistent results the instrumentation should include a torque wrench to measure the stability of the tamp, and research should be undertaken to determine the amount of impaction required. In our series we had no early loss of xation and satisfactory results overall probably because we learned from the experience of others. Using freeze-dried allograft, we obtained good clinical and radiographic results [24] that compare with larger series of fresh frozen allograft. Only one patient required a revision for infection. This suggests that freeze-dried morselized cancellous allograft is suitable for impaction grafting of the femur. Although it does not have the biological properties of fresh frozen allograft, both our clinical and scintigraphic results indicate that this is not a disadvantage. The main disadvantage of freeze-dried allograft is its impaired mechanical strength. However, this can be overcome by vigorous impaction. There have been several retrieval studies of patients after impaction grafting [13 16]. These demonstrated that the impacted allograft resorbs and that new bone forms on the impacted graft. Fresh frozen allograft has better biological potential to stimulate bone formation and therefore is a better material for impaction grafting. We did not retrieve any specimens to assess the biological activity in the impacted freeze-dried graft mass, but the SPECT bone scintigraphy recorded activity similar to previous studies [25]. Indirectly, this suggests that similar events occur in freeze-dried allograft despite its potential biological limitations. It may be that the blood and bone debris of the patient that gets mixed into the graft mass during impaction is osteoinductive. This, with the stability provided by satisfactory impaction and stem xation, seems to create the conditions necessary for bone healing. Impaction grafting with freeze-dried cancellous allograft gave satisfactory results in our hands despite its biological disadvantages. Surgeons performing impaction grafting should accept that surgical technique is more important than material grafted. Longer-term follow-up and further research on this material will explain our results. If we can demonstrate that impaction grafting with freeze-dried cancellous allograft works after 5 years, an alternative method of biological reconstruction after loose total hip arthroplasty may be established.

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REFERENCES
1. 2. Slooff TJJH, Huiskes R, van Horn J, Lemmens AJ. Bone-grafting in total hip replacement for acetabular protrusio. Acta Orthop Scand 1984; 55:593 596. Schreurs BW, Slooff TJ, Buma P, Gardeniers JW, Huiskes R. Acetabular reconstruction with impacted morsellised cancellous bone graft and cement. A 10- to 15-year follow-up of 60 revision arthroplasties. J Bone Joint Surg Br 1998; 80:391 395. Gie GA, Linder L, Ling RSM, Simon J-P, Slooff TJJH, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg Br 1993; 75-B:14 21. Tsiridis E, Gie GA. Mal-united femoral fractures adjacent to loose total hip arthroplasties. Salvage with impaction grafting. A case report. Injury 2002; 33:81 83. Elting JJ, Mikhail WE, Zicat BA, Hubbell JC, Lane LE, House B. Preliminary report of impaction grafting for exchange femoral arthroplasty. Clin Orthop 1995; 319:159 167. Flugsrud GB, Ovre S, Grgaard B, Nordsletten L. Cemented femoral impaction bone grafting for severe osteolysis in revision hip arthroplasty. Good results at 4-year follow-up of 10 patients. Arch Orthop Trauma Surg 2000; 120(7 8):386 389. van Biezen FC, ten Have BL, Verhaar JA. Impaction bone-grafting of severely defective femora in revision total hip surgery: 21 hips followed for 41 85 months. Acta Orthop Scand 2000; 71:135 142. Knight JL, Helming C. Collarless polished tapered impaction grafting of the femur during revision total hip arthroplasty: pitfalls of the surgical technique and follow-up in 31 cases. J Arthroplasty 2000; 15:159 165. Jazrawi LM, Della Valle CJ, Kummer FJ, Adler EM, Di Cesare PE. Catastrophic failure of a cemented, collarless, polished, tapered cobalt-chromium femoral stem used with impaction bone-grafting. A report of two cases. J Bone Joint Surg Am 1999; 81:844 847. Meding JB, Ritter MA, Keating EM, Faris PM. Impaction bone-grafting before insertion of a femoral stem with cement in revision total hip arthroplasty. A minimum two-year follow-up study. J Bone Joint Surg Am 1997; 79:1834 1841. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early subsidence following femoral impaction grafting. J Arthroplasty 1997; 12:535 540. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction bone grafting in revision hip surgery. A high incidence of complications. J Bone Joint Surg Br 2000; 82:103 107. Linder L. Cancellous impaction grafting in the human femur: histological and radiographic observations in 6 autopsy femurs and 8 biopsies. Acta Orthop Scand 2000; 71:543 552. Mikhail WE, Weidenhielm LR, Wretenberg P, Mikhail N, Bauer TW. Femoral bone regeneration subsequent to impaction grafting during hip revision: histologic analysis of a human biopsy specimen. J Arthroplasty 1999; 14:849 853.

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16. 17. 18.

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26. 27.

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Nelissen RG, Bauer TW, Weidenhielm LR, LeGolvan DP, Mikhail WE. Revision hip arthroplasty with the use of cement and impaction grafting. Histological analysis of four cases. J Bone Joint Surg Am 1995; 77:412 422. Ling RS, Timperley AJ, Linder L. Histology of cancellous impaction grafting in the femur. A case report. J Bone Joint Surg Br 1993; 75:693 696. Galea G, Kopman D, Graham BJ. Supply and demand of bone allograft for revision hip surgery in Scotland. J Bone Joint Surg Br 1998; 80:595 599. Simonds RJ, Holmberg SD, Hurwitz RL, Coleman TR, Botteneld S, Conley LJ, Kohlenberg SH, Castro KG, Dahan BA, Schable CA, et al. Transmission of human immunodeciency virus type 1 from a seronegative organ and tissue donor. N Engl J Med 1992; 326:726 732. Conrad EU, Ericksen DP, Tencer AF, Strong DM, Mackenzie AP. The effects of freeze-drying and rehydration on cancellous bone. Clin Orthop 1993; 290:279 284. Friedlander GE, Strong DM, Sell KW. Studies on the antigenicity of bone. I. Freeze-dried and deep-frozen allografts in rabbits. J Bone Joint Surg Am 1976; 58A:854 858. Gazdag AR, Lane JM, Glaser D, Forster RA. Alternatives to autogenous bone graft: efcacy and indications. J Am Acad Orthop Surg 1995; 3:1 8. Jones KC, Andrish J, Kuivila T, Gurd A. Radiographic outcomes using freeze-dried cancellous allograft bone for spinal fusion in pediatric idiopathic scoliosis. J Pediatr Orthop 2002; 22:285 289. Yazici M, Asher MA. Freeze-dried allograft for posterior spinal fusion in patients with neuromuscular spinal deformities. Spine 1997; 22:1467 1471. Tokgozoglu M, Senaran H, Atilla B, Alpaslan AM. Does freeze dried allograft work in impaction grafting of the femur in revision hip arthroplasty? J Bone Joint Surg Br 2001; 83-B(suppl I):74. Mazhar Tokgozoglu A, Aydin M, Atilla B, Caner B. Scintigraphic evaluation of impaction grafting for total hip arthroplasty revision. Arch Orthop Trauma Surg 2000; 120:416 419. Timperley AJ, Gie GA, Lee AJC, Ling RSM. The femoral component as a taper in cemented total hip arthroplasty. J Bone Joint Surg Br 1993; 75-B(suppl 1):33. Gie GA, Fowler JL, Lee AJC, Ling RSM. The long-term behaviour of a totally collarless, polished femoral component in cemented total hip arthroplasty. J Bone Joint Surg (Br) 1990; 72-B:935. Henman P, Finlayson D. Ordering allograft by weight: suggestions for the efcient use of frozen bone-graft for impaction grafting. J Arthroplasty 2000; 15:368 371. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR. Mechanical considerations in impaction bone grafting. J Bone Joint Surg Br 1999; 81:118 124. Masterson EL, Masri BA, Duncan CP. The cement mantle in the Exeter impaction allografting technique. A cause for concern. J Arthroplasty 1997; 12:759 764. Masterson EL, Masri BA, Duncan CP, Rosenberg A, Cabanela M, Gross M. The cement mantle in femoral impaction allografting. A comparison of three systems from four centres. J Bone Joint Surg Br 1997; 79:908 913.

25
Enmeshed Impacted Bone Allograft at the Femoral Side
Henri Migaud, Christophe Chantelot, Francois Giraud, Christophe Jardin, and Antoine Duquennoy
University Hospital of Lille Lille, France

I.

INTRODUCTION

Even with the so-called second- or third-generation cementing technique, cemented femoral revision is a problem [1,2]. The greater the number of revisions, the lower is the survival rate [3 5]. This is because bone stock does not recover spontaneously without grafting as cement occupies the areas of bone loss [6] and the cement/bone interface is weak as there is little cancellous bone into which cement can penetrate [7]. In cemented femoral revision without bone grafting, radiolucent lines at the cement/bone interface are often seen on the immediate postoperative x-ray, indicating that the new implant is loose and has limited prospects of long-term survival (Fig. 1) [8]. To avoid these problems of cemented femoral revision, we introduced the new technique of bone grafting in the mid-1980s. The aim was to improve bone stock, particularly in young patients, to make any subsequent revision easier and to improve cement/bone xation to decrease the rate of loosening. Slooff et al. [9] had impaction-grafted acetabular bone defects, and we introduced it for femoral revision in 1986. The two specic features we adopted were obtaining stable xation with long femoral stems and protecting the graft from cement penetration with metal mesh [10,11]. This was one of a number of new techniques of bone grafting, and in all of them there was a tremendous improvement in bone stock never seen previously with conventional cemented revisions [12 15]. However, with the Exeter technique, a high rate of stem
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Figure 1 Repeated aseptic loosening of a cemented femoral revision with rapid appearance of radiolucencies after revision. (A) Loosening at 4 years follow-up of a primary hip replacement performed for femoral neck fracture. There was cement mantle breakage (arrow) and subsidence (double arrow). (B) A bone cement radiolucency occurred in all zones 6 months after revision surgery performed with a calcar cemented stem without grafting (second-generation cementation technique). The repeated loosening required a new revision one year later. (C) Aspect of the calcar revision stem after retrieval. Loosening was located at bone/cement interface. There was no macrointerlock between the cement and the smooth revised femoral canal.

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subsidence was reported. If prostheses subsided 5 mm, they were described as denitely loose in many classications [16]. Femoral stem subsidence was not regarded as loosening by the Exeter group. The Exeter procedure became very popular, but there was a high rate of femoral subsidence, particularly when the cement mantle was incomplete [17,18]. Femoral shaft fracture occurred postoperatively when there was severe bone loss extending to the shaft [19,20]. In contrast with the original Exeter technique, we try to obtain strong distal xation in healthy femur to achieve primary stability, facilitate bone graft incorporation, and prevent stem subsidence (Fig. 2G). Following our principles, Gie [21] and De Thomasson et al. [22] modied their impaction bone grafting technique by using longer stems for severe and extensive femoral defects. The aim of this chapter was to report our original technique of femoral reconstruction and to emphasize the points of technique that make it a safe and reproducible method.

II. A.

THE TECHNIQUE Preoperative Planning

Precise preoperative planning with templates is necessary to assess the stem length necessary to bypass the lytic lesion any potential difculty removing the previous prosthetic material and any indication for a distal cortical window. The stem should be cemented in the distal femur at least 3 5 cm distal to the femoral defect. A long stem should be used to bridge any cortical window (Fig. 2). Straight calcar reconstruction stems are inserted usually because they simplify the reconstruction and primary stability by their proximal shape. We used many calcar stem types without any difference in outcome (LandangerTM/Johnson and JohnsonTM, CeraverTM, Astel-ZimmerTM) (Figs. 3, 4, 5). We used metal mesh placed in the femoral medullary canal at the cement/ graft interface to avoid excessive cement penetration into the graft, reinforce the cement, and achieve an even cement mantle. The mesh alloy was compatible with that of the stem. We used titanium mesh (CeraverTM) with a titanium stem and strong stainless steel mesh from the X-change system (Stryker/HowmedicaTM) with stainless steel stems (Fig. 3). B. 1. Surgical Procedure Stage 1: Femoral Preparation

Although our technique can be performed through any surgical approach to the hip, there must be adequate exposure of the femoral medullary canal, which can be extended if required. An extended trochanteric osteotomy is preferred to a

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conventional one to reduce the risk of nonunion, which is high when bone stock is severely impaired [23]. The trochanteric osteotomy should not be extended so far as to compromise the capacity of the femur to contain bone graft. In fact, this technique needs an intact femoral canal, and we do not recommend it if the femur is fractured before surgery. A segmental cortical defect is not a contraindication, but we prefer to reconstruct with a bulk graft instead of mesh around the femur because it devitalizes the cortex (Fig. 3). Likewise, an intraoperative femoral fracture is not a contraindication if primary stability can be achieved and the graft contained. To avoid the long extended trochanteric osteotomy sometimes required to remove distal cement, we frequently use a distal cortical window that does not compromise graft containment (Figs. 4, 5). After complete removal of cement and granuloma, a sturdy distal polyethylene nonabsorbable plug (CeraverTM, Roissy, France) (Fig. 2A) is placed 3 5 cm below the distal end of the lytic lesion loss or 5 cm distal to any cortical window.

Figure 2 Surgical steps of the enmeshed impacted bone allografting technique. (A) After removal of the previous stem and cement, a distal plugging is performed. The stability of the plug should be adequate, as the reconstruction will be based on it. Its position should be determined on preoperative planning. Then a metallic cylinder is introduced in the femoral canal. The diameter of this cylinder corresponds to the diameter of the mid-part of the stem that is selected in preoperative planning. The distal end of the cylinder is larger than the distal revision stem and must t the distal femoral canal in order to avoid graft penetration into the distal healthy femur. (B) Once the femoral rod in place, the reconstruction with morselized allograft is performed. The grafts are introduced from the proximal opening of the femoral canal. When performed, a cortical window could also be used for graft packing. (C) The metallic mesh is molded around the trial stem. The length of the mesh is determined during preoperative planning and adjusted during surgery to be equal to the length of bone grafting. Few absorbable sutures can be used to maintain the mesh molded around the trial stem. (D) After femoral metallic rod removal, the trial stem and the mesh are both introduced into the reconstructed femoral canal (white zone with black dots) and rmly impacted. (E) The trial stem is removed leaving the mesh in the femoral canal. At this stage a complementary femoral reconstruction can be performed by packing morselized allograft around the mesh at the proximal aspect of the femur. (F) The cement (black zone with white dots) is introduced in the femur. A second- or third-generation cementing technique is required according to the extended length of revision stems and in order to obtain distal xation. (G) Final aspect of the procedure. The reconstruction is achieved by graft packing around the mesh. The grafts are protected from excessive cement penetration by the mesh, which also reinforces the cement mantle and make it regular. Distal cementation in the healthy area of the femur achieves stable initial xation.

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Figure 3 Reconstruction with enmeshed of a femoral loosening grade 2 according to French Orthopaedic Society score. (A) There was segmental defect of the distal lateral cortex and loss in thickness of proximal medial and lateral cortex. (B) Postoperative AP view. The segmental defect was treated by bulk allograft xed by cerclage. The proximal reconstruction was performed with impacted morselized allograft. The mesh (X-Change system) is placed in front of the graft. (C) Six years later there was favorable bone reconstruction and no stem subsidence.

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Figure 4 Long-term result of a reconstruction with enmeshed grafting applied to a femoral loosening grade 3 according to French Orthopaedic Society score. (A) Severe osteolysis extended to the diaphyseal area. (B) AP view 2 years after femoral reconstruction (the cup liner was changed). There was reappearance of the medial and lateral cortex and trabeculations in the grafts. The mesh and the stem were made of titanium alloy. A distal cortical window, performed to remove previous distal cement was united. Note adequate distal cementation and the absence of stem subsidence. (C) AP view 13 years after revision. The cortical thickness remains fully corrected. There was no recurrence of osteolysis despite wear of the cup liner.

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Figure 5 Reconstruction of a severe femoral bone loss (grade 4) with enmeshed impacted allograft. (A) Severe osteolysis and destruction of the femoral cortex extended to the diaphyseal area with stem subsidence. (B) AP postoperative view. A distal cortical window was performed to remove distal cement because of the weakness of the proximal femur. The reconstruction was performed with a titanium mesh and calcar revision stem. This last one had diaphyseal xation and the mesh was extended in front of the graft. (C) Nine years later there was satisfactory reconstruction of the femoral cortex and reappearance of trabeculations in the graft area. There was no subsidence of the stem nor recurrence of osteolysis (the cup liner was changed during femoral revision).

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2.

Stage 2: Bone Graft Preparation

Morselized allografts are obtained from fresh frozen femoral heads with all the cartilage removed in all cases. Until 1991 the bone was morselized by hand, and after that a bone mill was used for greater consistency (Figs. 3, 5). 3. Stage 3: Femoral Bone Grafting

There is no manufactured instrumentation for this stage. We tried some proprietary devices [X-Change (Strycker/HowmedicaTM), Elite (DePuy/Johnson and JohnsonTM)], but none were suitable for long stems. The only special instrument we use is a straight metal cylinder, around which we impact morselized allograft. The diameter of the cylinder corresponds to that of the mid-part of the stem and is determined during preoperative planning (Fig. 2A). The distal end of the cylinder is larger than the distal revision stem to stop graft from entering the normal distal femur and interfering with distal xation and stem stability. Once the guide is positioned, morselized grafts are introduced and impacted around it in areas of bone loss (Fig. 2B) creating a new femoral canal shaped for stem and mesh insertion. Graft can be introduced through the distal window if one has to be made. Segmental defects must be contained with bulk allograft (Fig. 3). If the shaft fractures during the operation, it must be reduced and xed before impaction. The next step is grafting the proximal 3 5 cm of the femoral canal. If a cortical window or proximal trochanteric osteotomy is performed, it should be xed with metal wires just before or during graft impaction. 4. Stage 4: Mesh Preparation

The metallic mesh is moulded around a trial stem and xed with some circumferential absorbable sutures (Fig. 2C). The length of the mesh is adapted to t the bone loss reconstructed by allograft (Figs. 2G, 4). After removal of the metal cylinder, a composite of the trial stem and mesh is then introduced into the reconstructed canal and appropriately positioned to restore leg length and femoral offset (Fig. 2D). If the femur is severely defective, cerclage wiring can be performed to prevent intraoperative fracture before insertion of the denitive stem. Then the trial stem is removed, leaving the mesh in the femoral canal (Fig. 2E). At this point, if necessary, further proximal graft can be impacted around the mesh. 5. Stage 5: Cement Insertion and Fixation of the Denitive Stem

Whether cement is inserted prograde or retrograde, the aim is to obtain an adequate cement xation into the virgin distal femur (Figs. 2F, G). A vacuum venting tube should be placed in the distal femur to improve lling if cement is inserted prograde. All the stems were cemented with high-viscosity,

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gentamicin-loaded cement (Palacos GentaTM, Schering-Plough). The nal aim is satisfactory xation to the virgin distal femur, adequate proximal femoral reconstruction by impaction grafting protected by metal mesh, reinforcement of cement with mesh, and a collared stem to prevent subsidence (Fig. 2G). C. Postoperative Management

When femoral bone loss defect was limited and there was satisfactory distal xation, weight bearing was permitted after 3 days when the drains had been removed. Otherwise it was delayed for 6 weeks.

III.

CLINICAL DATA

Between 1986 and 1995, we revised 435 total hip replacements for femoral loosening, 36 of which were performed using the technique described above. The technique was employed in selected cases of aseptic femoral loosening with severe bone loss but a contained or limited cortical defect and no preoperative periprosthetic fracture. Eight of these 36 hips undergone previous revision surgery. There were 30 patients with a mean age of 61+14 years (SD) (16 men, 14 women). The mean follow-up was 10 years. No patient was lost to follow-up, but two died after 8 years of follow-up with their prosthesis in place at the time of death. Only one stem, in an active 48-year-old patient, had recurrent loosening and required further revision after 10 years. There was loosening at the cement/bone interface, which related to progressive proximal osteolysis and massive cup wear. There was no evidence that it was related to the mesh as the stem and cement were mobile and easily removed in one piece. No other stem revision was required. Subsidence was assessed on x-rays with a digitizer (OrthographicsTM) with a signicant threshold of 4 mm. After 4 years of follow-up, one stem had subsided 4.4 mm. The subsidence was not progressive, and the hip was asymptomatic. There were no postoperative fractures. Using the French Orthopaedic Society scoring system [24], bone loss was grade 2 in three hips. Grade 2 bone loss is destruction of the lateral femoral cortex and slightly impairment of the medial (Fig. 3). Twenty-six hips had grade 3 bone loss, which was severe destruction of the medial and lateral femoral cortex (Fig. 4). Seven hips were grade 4, in which the medial and lateral femoral cortex were thin and ballooned (Fig. 5). The remainder were rated grade 1, which involved slight destruction of the femoral cortex or grade 0 with no bone loss. Bone loss always improved at follow-up with reappearance of the femoral cortex and normal trabecular bone (Fig. 5). Except for the case that loosened, there was no bone lysis or stress shielding. The Merle dAubigne hip score improved

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from 9.8 preoperative to 16.5 at follow-up, and 85% of the hips had no pain or slight pain at follow-up.

IV.

DISCUSSION

Currently, impaction bone grafting is restricted by availability of allograft and risk of viral transmission. The procedure is technically demanding with a high complication rate. Complications such as shaft fracture prevent satisfactory recovery of bone stock. Pekkarinen et al. [25] experienced with the Exeter technique complications in 34 out of 68 cases (50%). Knight and Helming [26] had a 16% incidence of femoral fracture and 16% subsided over 5 mm. Our original technique obtained strong distal xation and bridged the bone defect. We were able to prevent postoperative fracture, even in severely defective femora, and the long stems never caused stress-shielding in our experience. Adequate distal xation may also prevent subsidence, which is frequent after impaction bone grafting. Only 2% of our cases subsided always less than 5 mm. The collared stem may have contributed to this result, as suggested by Fetzer et al. [27], who reported only 3.8% subsidence (all less than 5 mm) with a similarly collared femoral component. Likewise, Ullmark et al. [28] reported no subsidence exceeding 5 mm in cases with severe bone destruction (Endoklinik grade 3 and 4) when using long-collared stems with impaction grafting. The removal of cartilage before milling was investigated by Bavadekar et al. [29], who concluded that it improved the stiffness of the impacted graft. This probably also helped to prevent subsidence in our series. Ullmark and Nilsson [30] and Karrholm et al. [31] reported that the size of bone chips and force of impaction inuence in vitro graft compactness and possibly subsidence. However, this work has to be conrmed, and even if it is, poor graft quality may still cause subsidence. It therefore seems reasonable to prevent subsidence by a long-collared stem rather than relying on the variable strength of impacted graft. An inadequate cement mantle can fracture and has been associated with severe subsidence after impaction bone grafting [18,32]. In our technique, mesh reinforced the cement and prevented cement fracture over follow-up of 10 years. The mesh also contributed to an even cement mantle of at least 2 3 mm and prevented excessive cement penetration into the graft. Excessive cement penetration does not improve xation in vitro [33] and may impair graft incorporation. Impaction bone grafting is a time-consuming technique [34], and locked or unlocked cementless stems have become very popular in Europe for femoral revision. Spontaneous bone repair often occurs with cementless stems [6,35,36] without difcult and time-consuming bone grafting. However, we do not know how to improve spontaneous bone repair around cementless stems. There is now

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10-year follow-up of impaction bone grafting, and the technique has stood the test of time. All series of impaction bone grafting have restored bone stock, and remodeling has been demonstrated histologically [37]. However, the complication rate of the original Exeter technique makes its reproducibility questionable. Our original technique was reproducible and had a low complication rate. Longer stem may cause problems in further revision, but this only occurred in 2% in our series after follow-up of 10 years. The indications for enmeshed impacted allograft are: (1) bone loss with a contained defect in a femur that is not fractured, (2) aseptic loosening, and (3) severe distal bone loss that risks perioperative fracture or prevents adequate xation of a standard cemented stem. In our experience, impaction bone grafting is best suited to patients under 75 years old. Older patients usually have severe osteoporosis that risks intraoperative fracture. Impaction bone grafting is better than cementless revision when the femoral canal is ectatic (.15 19 mm). In ectatic femora, large cementless stems have to be used and may produce severe stress shielding. Two situations are not suited for impaction bone grafting: severe femoral bone loss with extensive segmental defects and minor bone loss. Extensive femoral defects are best treated with a bulk allograft or cementless hydroxyapatite (HA)-coated stem and minor bone loss [38] with a cementless revision stem, which is a simple and effective way of restoring bone stock [6,35]. Our original technique is successful in the long term, and our modication of the Exeter technique has had no adverse effect on results after 3 [11], 6 [10], and 10 years of follow-up (Fig. 4).

REFERENCES
1. Eisler T, Svensson O, Lyer V, Wejkner B, Schmalholz A, Larsson H, Elmstedt E. Revision total hip arthroplasty using third-generation cementing technique. J Arthroplasty 2000; 15:974 981. Stromberg CN, Herberts P. Cemented revision total hip arthroplasties in patients younger than 55 years old. A multicenter evaluation of second generation cementing technique. J Arthroplasty 1996; 11:489 499. Repten JB, Varmarken JE, Rock ND, Jensen JS. Unsatisfactory results after repeated revision of hip arthroplasty. 61 cases followed for 5 (1 10) years. Acta Orthop Scand 1992; 63:120 127. Ritter MA, Campbell ED. The survival of the cemented femoral component of a total hip replacement. Clin Orthop 1989; 243:143 147. Wyssa B, Raut VV, Siney PD, Wroblewski M. Multiple revision for failed Charnley low-friction arthroplasty. J Bone Joint Surg (Br) 1995; 77:303 306. Courpied JP, Migaud H. Aseptic revision of hip arthroplasties: the femoral side. Rev Chir Orthop 2000; 86(suppl 1):33 90.

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Dohmae Y, Betchold JE, Sherman RE, Puno RM, Gustilo RB. Reduction in cementbone interface shear strength between primary and revision arthroplasty. Clin Orthop 1988; 236:214 220. Hultmark P, Karrholm J, Stromberg C, Herberts P, Mose CH, Malchau H. Cemented rst-time revisions of the femoral component: prospective 7 to 13 years follow-up using second-generation and third-generation technique. J Arthroplasty 2000; 15:551561. Slooff TJ, Huiskes R, Van Horn J, Lemmens AJ. Bone grafting in total hip replacement for acetabular protrusion. Acta Orthop Scand 1984; 55:593 596. Migaud H, Jardin C, Fontaine C, Pierchon F, dherbomez O, Duquennoy A. Femoral reconstruction with endosteal bone allografts protected by a metallic mesh in reoperation of total hip prosthesis. 19 cases with an average follow-up of 83 months. Rev Chir Orthop 1997; 83:360 367. Pierchon F, Migaud H, Duquennoy A. Reconstitution of femoral bone stock in loosening of total hip prosthesis. Acta Orthop Belg 1993; 59:278 286. Gie GA, Linder L, Ling RSM, Simon JP, Sloof TJJH, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg (Br) 1993; 75:14 21. Meding JB, Ritter MA, Keating EM, Faris PM. Impaction bone-grafting before insertion of a femoral stem with cement in revision total hip arthroplasty. A minimum two-year follow-up study. J Bone Joint Surg (Am) 1997; 79:1834 1841. Elting JJ, Mikhail WE, Zicat BA, Hubbell JC, Lane LE, House B. Preliminary report of impaction grafting for exchange femoral arthroplasty. Clin Orthop 1995; 319:159167. Van Biezen FC, Ten Have BL, Verhaar JA. Impaction bone-grafting of severely defective femora in revision total hip surgery: 21 hips followed for 41 85 months. Acta Orthop Scand 2000; 71:135 142. Johnston RC, Fitzgerald RH Jr, Harris WH, Poss R, Muller ME, Sledge CB. Clinical and radiographic evaluation of total hip replacement. A standard system of terminology for reporting results. J Bone Joint Surg (Am) 1990; 72:161 168. Malkani AL, Voor MJ, Fee KA, Bates CS. Femoral component revision using impacted morsellised cancellous graft. A biomechanical study of implant stability. J Bone Joint Surg (Br) 1996; 78:973 978. Masterson EL, Masri BA, Duncan CP, Rosenberg A, Cabanela M, Gross M. The cement mantle in femoral impaction allografting. A comparison of three systems from four centres. J Bone Joint Surg (Br) 1997; 79:908 913. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early subsidence following femoral impaction grafting. J Arthroplasty 1997; 12:535 540. Franzen H, Toksvig-Larsen S, Lidgren L, Onnerfalt R. Early migration of femoral components revised with impacted cancellous allografts and cement. A preliminary report of ve patients. J Bone Joint Surg (Br) 1995; 77:862 864. Gie GA. Impaction grafting is a treatment of choice in revision total hip arthroplasty. Seventeenth Current Concepts in Joint Replacement, Orlando, FL, Dec 13 16, 2000, paper # 31. De Thomasson E, Guinguand O, Mazel C. Modied Exeter technique for reconstruction of femoral bone loss in revision total hip arthroplasty. Does prosthesis stability affect remodeling of the graft? Eur J Orthop Surg Traumatol 2000; 10:3542.

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Migaud et al. Leopold SS, Berger RA, Rosenberg AG, Jacobs JJ, Quigley LR, Galante JO. Impaction allografting with cement for revision of the femoral component. A minimum four-year follow-up study with use of a precoated femoral stem. J Bone Joint Surg (Am) 1999; 81:1080 1092. ` ` Vives P. Descellement aseptique des protheses totales de hanche repris par prothese cimentee. Rev Chir Orthop 1989; 75(suppl 1):23 60. Pekkarinen J, Alho A, Lepisto J, Ylikoski M, Ylinen P, Paavilainen T. Impaction bone grafting in revision hip surgery. A high incidence of complications. J Bone Joint Surg (Br) 2000; 82:103 107. Knight JL, Helming C. Collarless polished tapered impaction grafting of the femur during revision total hip arthroplasty: pitfalls of the surgical technique and follow-up in 31 cases. J Arthroplasty 2000; 15:159 165. Fetzer GB, Callaghan JJ, Templeton JE, Goetz DD, Sullivan PM, Johnston RC. Impaction allografting with cement for extensive femoral bone loss in revision hip surgery: a 4- to 8-year follow-up study. J Arthroplasty 2001; 16(suppl 1):195 202. Ullmark G, Hallin G, Nilsson O. Impacted corticocancellous allografts and cement for femoral revision of total hip arthroplasty using Lubinus and Charnley prostheses. J Arthroplasty 2002; 17:325 334. Bavadekar A, Cornu O, Godts B, Delloye C, Van Tomme J, Banse X. Stiffness and compactness of morselized grafts during impaction: an in vitro study with human femoral heads. Acta Orthop Scand 2001; 72:470 476. Ullmark G, Nilsson O. Impacted corticocancellous allografts: recoil and strength. J Arthroplasty 1999; 14:1019 1023. Karrholm J, Hultmark P, Carlsson L, Malchau H. Subsidence of a non-polished stem in revisions of the hip using impaction allograft. Evaluation with radiostereometry and dual-energy x-ray absorptiometry. J Bone Joint Surg (Br) 1999; 81:135 142. Masterson EL, Busch CA, Duncan CP, Drabu K. Impaction allografting of the proximal femur using a Charnley-type stem: a cement mantle analysis. J Arthroplasty 1999; 14:59 63. Berzins A, Sumner DR, Wasielewski RC, Galante JO. Impacted particulate allograft for femoral revision total hip arthroplasty. In vitro mechanical stability and effects of cement pressurization. J Arthroplasty 1996; 11:500 506. Rorabeck CH. In Opposition to impaction grafting is a treatment of choice in revision THA. Seventeenth Current Concepts in Joint Replacement, Orlando, FL, Dec 13 16, 2000, paper # 32. Bohm B, Bischel O. Femoral revision with the Wagner SL revision stem: evaluation of one hundred and twenty-nine revisions followed for a mean 4.8 years. J Bone Joint Surg (Am) 2001; 83:1023 1031. Lawrence JM, Engh CA, Macalino GE. Revision total hip arthroplasty. Long-term results without cement. Orthop Clin North Am 1993; 24:635 644. Ullmark G, Obrant KJ. Histology of impacted bone-graft incorporation. J Arthroplasty 2002; 17:150 157 Vielpeau C, Hulet C, Elmoataz H, Texier A, Geffard B. Advantages and limitations of impacted morselized grafts. Rev Chir Orthop 2000; 86(suppl 1):77 80.

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26
Impaction Bone Grafting at the Hip: A Clinical Review
Mickey S. Cho and Michael T. Casnellie
William Beaumont Army Medical Center El Paso, Texas, U.S.A.

Seth S. Leopold
University of Washington Medical Center Seattle, Washington, U.S.A.

I.

INTRODUCTION

Loosening of the femoral component after total hip arthroplasty is often associated with loss of proximal femoral bone stock. A variety of techniques have been described for revision of the femoral component in a failed total hip arthroplasty (THA) with severe bone stock deciency. Cemented [1,2] and cementless [3 5] (Fig. 1) methods of xation have been successful over both intermediate- and long-term follow-up; however, these techniques are not always suitable when there is massive bone stock loss (Fig. 2). The goal of these techniques is to provide a stable and durable reconstruction despite the loss of bone [1 5]. In the most severe cases, allograft-prosthetic composites [6 9] and proximal femoral replacement megaprostheses [10 12] offer salvage options but are associated with high rates of severe complication, including dislocation, deep infection, and nonunion of allograft-prosthesis composites. The technique of cancellous impaction allografting with cement, unlike the other femoral revision techniques previously mentioned, attempts to reconstitute

The views expressed in this article are those of the authors and do not reect the ofcial policy of the Department of Defense or the United States Government.

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Figure 1 Anteroposterior hip radiograph of an extensively porous-coated, cementless, revision femoral component. While this is a durable revision technique, it is occasionally associated with severe proximal stress shielding, as seen in this radiograph. (Figure courtesy of Aaron G. Rosenberg, M.D.)

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Figure 2 Anteroposterior hip radiograph showing severe bone loss around a failed femoral component. This case would be difcult to revise using standard cementless or cemented techniques, and might be a suitable case for impaction allografting. (Figure courtesy of Aaron G. Rosenberg, M.D.)

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bone defects in the proximal femur while at the same time gaining stable xation [6,8,13 16]. This approach consists of cementing a femoral stem into a neoendosteum created within the decient femur by containing and tightly packing morselized cancellous bone graft. One potential advantage of impaction allografting is the reconstitution of bone stock [15,17], which may be desirable for future revision operations, should they be necessary. The purpose of this chapter is to review the history, indications, surgical techniques, complications, and published clinical results associated with femoral impaction allografting.

II.

HISTORY OF IMPACTION ALLOGRAFTING

Impaction allografting with morselized cancellous bone was rst described as a technique for hip reconstruction in protrusio acetabuli [18]. Gie et al. later adapted the technique for use on the femoral side of a failed THA [15]. It was rst used in England, without cement, for femoral reconstruction in 1985 [19]. Two years later, the originators of the technique, Gie et al., performed the procedure with cement using the Exeter stem (Stryker-Howmedica-Osteonics, Rutherford, NJ) [15]. Numerous studies since have reported clinical results using this technique or one of its variants [6,13,14,16,20 34]. A major controversy that continues to surround this surgical approach is whether it should be considered a system or a surgical technique. Early advocates of impaction allografting [15,19] as well as some more recent proponents [13,14,16,17] have maintained that success with this approach depends not just on a high level of surgical performance, but also on a femoral component of a particular design and surface nish. Many of these investigators have indicated that the properties of the Exeter stem (Stryker-HowmedicaOsteonics, Rutherford, NJ) [15] or the very similar CPT stem (Collarless Polished Taper stem by Zimmer, Warsaw, IN) [13,14,16,17,21,31]both of which are highly polished, double-tapered, noncollared implantsare required to achieve controlled subsidence and properly load the cancellous bone graft. These investigators have indicated that subsidence of the wedge-shaped stem provides a benecial level of compression to the graft and encourages graft remodeling and reconstitution of decient bone stock. Other published reports have highlighted the numerous variables intrinsic to impaction allografting and have attempted to determine whether the benets of bone stock reconstitution could be achieved without the disadvantages associated with stem subsidence [13,20,25], including fracture, dislocation, and limb length inequality. In essence, these investigators and others have posed the question of whether impaction allografting is a surgical technique, with numerous modiable variables whose adjustment might lead to higher or lower success rates, or a system that consists of a particular stem design, instrumentation, graft type, and surgical

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approach. This line of inquiry has led to the exploration of other implant designs [20,22,23,29,35,36], different means of graft packing and insertion [30], stemrasp mismatches [37], use of extended trochanteric osteotomies with impaction grafting [38,46], and even performance of the technique (generally unsuccessfully) without cement [29]. The alternative stem designs have covered the full range of available implant geometries and surface nishes, including a Charnley-type stem [5,32,36], a proximally roughened design (Spectron EF; Richards, Memphis, TN) [22,23]; a roughened, precoated and normalized design (Harris Precoat; Zimmer, Warsaw, IN) [20]; and a collared, proximally porous coated, titanium-alloy implant (Bi-Metric and Head-Neck stems; Biomet, Warsaw, IN) [29]. Longer follow-up will be needed to denitively ascertain whether cancellous impaction allografting should be considered a system or a technique.

III.

ALGORITHM FOR FEMORAL RECONSTRUCTION

The following is an algorithm that can be used to guide surgical decision making in a failed femoral component (Fig. 3). Once infection is ruled out, both metaphyseal and diaphyseal bone stock are assessed. If the diaphysis is intact and there is minimal metaphyseal bone stock disruption, conventional cemented or cementless xation may be appropriate. Such minimally damaged femurs would be expected to do well with most revision techniques [1 6]. If there is more severe bone loss, but the femoral canal diameter is less than or equal to 18 mm and intra-operatively at least 4 6 cm of intact diaphyseal bone is available to provide solid, cementless xation with good rotational stability, then a 6 8 inch extensively porous-coated stem has proven very successful [3,4,39]. Proximally coated cementless stems have not been satisfactory over the long term in such situations [40]. When the femoral diaphyseal canal is greater than 18 mm, the cortices have thinned to the point where cementless xation poses an undue risk of fracture and there is less than 4 cm of distal diaphysis available for press-t xation, revision options include: proximal femoral replacement (Fig. 4), allograft-prosthetic composite, and impaction allografting [3,6,8,10]. Impaction allografting may be considered in this setting when priority is given to the restoration of proximal bone stock, such as in a younger or more active patient.

IV.

SURGICAL APPROACHES AND TECHNICAL PEARLS

Gie et al. originally published results using femoral impaction allografting with cement in 1993 [15]. The original stem used by that group was the highly

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Figure 3 Algorithm for revising a failed femoral component in total hip arthroplasty.

polished, collarless, double-tapered Exeter stem (Stryker-Howmedica-Osteonics, Rutherford, NJ). Controversy exists over the signicance of implant shape and surface nish [13,16,25,35], but no randomized, controlled clinical trials have addressed these issues. Regardless of the stem type used, it is agreed that uniform and consistent insertion of bone graft should be achieved, that the neo-endosteum is fashioned in a shape similar to the prosthesis to be inserted, and that the nal rasp should be larger in all dimensions than the actual implant in order to improve the quality of the cement mantle [37]. To this end, several manufacturers have designed

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Figure 4 Anteroposterior radiograph of a proximal femoral replacement prosthesis or megaprosthesis. A megaprosthesis may be used in cases of severe femoral bone loss; however, they are associated with high rates of infection and dislocation.

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systems, including instrumentation, that simplify delivery of morselized cancellous graft chips, in addition to size- and shape-matched impaction tamps [23,25,30,35,41]. It is imperative that the surgeon perform meticulous preoperative planning prior to undertaking femoral impaction allografting. Deep infection must be ruled out using necessary blood work, imaging studies, and, when indicated, hip aspiration. Intraoperative frozen sections may also be useful to help exclude infection [42,43]. Preoperative radiographs should include an AP pelvis and an AP and lateral radiograph of the affected hip, which include several inches of femur beyond the anticipated revision stem tip. Radiographs and physical examination together can be used to determine appropriate limb length; several approaches have been proposed to guide these measurements [44,45]. Abnormal femoral morphology, including bowing and angular deformity, should be noted. Varus deformities of the proximal metaphyseal-diaphyseal junction are frequently seen in femurs with long-standing aseptically loose stems. Since the most common major complication of femoral impaction allografting is intra- and postoperative fracture, it is critical to locate cavitary and segmental defects in the femur, as well as areas of ectatic cortex that might require reinforcement with strut allografts or wire mesh [14 16,20,23 25,29]. Particular attention also needs to be paid to implant templating. Early studies with femoral impaction allografting used prostheses that were similar in length to primary reconstruction implants [13 17]. Because of the concern about predisposing patients to a higher fracture risk by using stems that did not extend past signicant femoral defects, longer implants have been used to bypass particularly severe areas of cortical attenuation or damage [5,25]. For cases where signicant femoral neck erosion has occurred, calcar-replacement implants are sometimes used (Smith-NephewRichards, Memphis, TN; Stryker-Howmedica-Osteonics, Rutherford, NJ); however, some proponents of impaction allografting prefer reconstructing the calcar and femoral neck bone stock with impaction allografting along with mesh, cortical allografts, and cerclage wires [15]. Either calcar-replacement stems or proximal bone grafting is necessary to achieve equal leg length and to minimize the likelihood of dislocation. Regardless of the implant and graft-insertion system used, impaction allografting begins with an adequate surgical exposure. Numerous approaches have been used, including anterolateral, posterior, lateral transtrochanteric, and lateral with extended trochanteric osteotomy [13,14,20,23,30,35,46]. While a trochanteric osteotomy may improve exposure and facilitate failed component removal, nonunion rates from 33 to 50% have been reported using this approach in impaction allografting cases [16,20]. Likewise, extended trochanteric osteotomies have been shown to be biomechanically and clinically inferior for impaction allografting [38,46]. Therefore, it is best to avoid femoral osteotomies whenever possible.

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Once adequate exposure is achieved, the loose or failed femoral implant is removed and the entire cement mantle extracted. Any debris or brous material remaining in the femoral canal is removed as well. While removal of canal debris may be tedious, extreme caution must be exercised while removing retained cement. This is the part of the procedure where femoral perforation is most likely to occur. Rates of femoral perforation with impaction allografting have ranged from 5 to 24% in published series [14 16,20,21,34,35]. Adequate suction devices, instruments specically designed for cement removal, and exible beroptic illumination help minimize this danger. Once the canal is debrided, cavitary defects and regions of ectatic cortex must be reinforced with either wire mesh or cortical strut allografts and cerclage wire. This step is critical to decrease the possibility of iatrogenic fracture during stem impaction. Next, a canal-restricting plug is inserted approximately 2 cm distal to the expected site of the tip of the revision prosthesis. Any cement distal to the plug may be left in place to minimize the likelihood of causing a distal perforation. In fact, a well-bonded, occlusive, distal cement plug may be left in situ to act as a canal restrictor, provided that it is at an appropriate level, and the graft insertion system does not depend on a centralizing rod that threads into a distal plastic plug. Before inserting the morselized bone graft, it is imperative that the impactors used to sculpt the neo-endosteum can be correctly aligned within the femoral canal. Malalignment of the neo-endosteum created by poorly aligned tamps or impactors will cause a malaligned implant. Some systems centralize the neo-endosteum using cannulated tamps or impactors that pass over a threaded rod, which itself inserts into the distal canal-restricting plug or into the retained distal cement plug itself. Insertion of the bone graft may be accomplished by hand or by using any number of commercially available delivery systems. Stryker-HowmedicaOsteonics (Rutherford, NJ) manufactures a bone graft injecting gun (similar to a cement gun), which attaches to tubes sized to the native endosteum in order to ll the femoral canal with cancellous bone in a uniform fashion [41]. The Smith-Nephew-Richards (Memphis, TN) system uses a hand-powered syringe, with or without radial reaming impactors [23,30]; other devices are also commercially available. It is imperative that regardless of which system is used, the neo-endosteum and nal implant be neutrally aligned. The most common malalignment error is to place the neo-endosteum and nal implant in varus, which would be expected to compromise long-term results. Although controlled trials comparing allograft types (fresh-frozen, irradiated, freeze-dried) or bone graft substitutes have not been performed, the procedure is most commonly performed using fresh-frozen cancellous bone chips. Fresh-frozen allograft has better compliance for purposes of impaction than does freeze-dried allograft, which tends to crumble or pulverize. In addition, the osteoinductive properties of freeze-dried allograft are not clear, and adequate

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graft incorporation have only been shown in several small series [26,42]. A series using freeze-dried allograft by Tokgozoglu et al. challenged this view, but the small sample size and short-term follow-up presented in that report limits its ability to draw rm conclusions on the topic [26]. Another recent series using freeze-dried impacted allograft for acetabular revisions showed promising intermediate results, but conclusions about the series may not be directly transferable to femoral impaction allografting [42]. Cancellous allograft may be prepared from allograft femoral heads that are morsellized to 2 4 mm chips using a bone mill (Lere Bonemill, DePuy Inc., Allendale, NJ). Premorselized fresh-frozen cancellous allograft also is commercially available (Allosource, Denver, CO), which can save time in the operating room. Some investigators have specically advocated nonirradiated fresh frozen allograft [15,41] because of the potentially improved mechanical properties compared to allograft that has been irradiated; again, this belief has not been clinically validated with biomechanical or randomized, controlled trials. Once the endosteum has been debrided and the distal canal restrictor has been placed, approximately 2 cm of graft is impacted against the canal restrictor, leaving enough length proximal to that graft to permit stem insertion. Graft is then further inserted to ll the canal and a neo-endosteum is fashioned using handheld tamps [41], cannulated impactors or tamps [20,41], or reamers [30]. The graft impaction process is necessarily vigorous, creating signicant hoop stresses in the femur. Intraoperative fractures occur most commonly during this step in the procedure, and the importance of reinforcing femoral defects with wire mesh or strut allografts and cerclage wires prior to impaction cannot be overstated. The instruments used to fashion the neo-endosteum are contoured to match the nal prosthesis used. Ideally, the tamps are 1 2 mm larger than the nal implant so that there is suitably thick cement mantle surrounding the stem [35]. This was not the case with some early impaction grafting systems where some tamps were actually smaller than the nal implant; the result was inconsistent cement mantles [35]. Cement mantle quality may be difcult to assess radiographically because of the presence of overlying bone graft, implant, cortical struts, wire mesh, and other hardware. Nevertheless, even with properly oversized tamps, poor cement mantles (Harris grade C and D [48]) are common in series reporting on impaction allografting [20,35]. Since loss of femoral neck bone stock to the level of the lesser trochanter is common in these cases, it is important that the surgeon be prepared to use other landmarks to establish correct femoral anteversion in order to avoid postoperative dislocation, such as the distal femoral condyles or the linea aspera. Once the neo-endosteum has been created, the nal tamp in most systems may be used to perform a trial reduction to evaluate the stability of the reconstruction (Fig. 5). At this time supplemental bone graft may also be packed around the trial stem in the upper end of the femur using a hand-held bone punch.

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Figure 5 Intraoperative photograph demonstrating the nal tamp during an impaction allografting procedure. This photograph was taken after the bone graft had been inserted and tightly packed. In these cases, the nal tamp may be used as a trial to evaluate stability prior to cementing. (Figure courtesy of Aaron G. Rosenberg, M.D.)

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If the impaction grafting procedure is performed properly, an impressive amount of both axial and rotational stability can be achieved with the nal tamp (Fig. 6). One system even recommends verifying rotational stability using a torque wrench to 9 11 N-m (80 100 in-lb) [23]. No visible rotation of the tamp should be observed when this torque is applied. Once acceptable stability has been achieved, the trial tamp is removed and the nal implant is cemented in the standard fashion. One notable difference from routine cementing is that the cement should be injected in a less viscous state than usual so that better cement penetration into the packed cancellous graft of the neo-endosteum can be achieved.

V. A.

PROBLEMS AND COMPLICATIONS OF IMPACTION ALLOGRAFTING General Complications

Femoral impaction allografting is one of the most technically challenging techniques used for femoral reconstruction; therefore, many investigators limit its use to the more difcult revisions. As a result, the complication rate can be high, especially in cases with more severe bone stock deciency [16,20,24,25,29]. The most common complication is intra- and post-operative femur fracture (Fig. 7), which will be discussed separately. As expected, the dislocation rate is higher than in primary total hip arthroplasty and has been reported to range from 0 to 14%. Postoperative infection is usually reported at a rate of 3 6% which is also considerably higher than in primary total hip arthroplasty. As mentioned previously, femoral osteotomies are not recommended in femoral impaction allografting. Nonunion of greater trochanteric osteotomies has been reported in 33 50% of cases [16,20]. Similarly, extended trochanteric osteotomies are discouraged after both clinical and biomechanical studies reported problems with that approach when combined with impaction allografting [38,46]. Osteotomies are suspected to do poorly because of compromised bone stock and cement interposition within the osteotomy site itself. Other reported complications include deep venous thrombosis, pulmonary embolus, postoperative myocardial infarction, pneumonia, heterotopic ossication, hardware-related trochanteric bursitis, and catastrophic stem failure [1416,20,24,29,49].

B.

Femoral Fracture and Perforation

The incidence of intra- and postoperative femur fracture ranges from 5 to 34% and has been a reported complication in nearly every series on this technique [14 16,20,21,24,25,27,29,31 34]. As anticipated, fracture is more likely in

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Figure 6 When impaction allografting is correctly performed, a signicant amount of axial and rotational stability should be obtained when trialing with the nal tamp.

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Figure 7 Intraoperative, antero-posterior radiograph taken during a case of impaction allografting, which shows an intraoperative femur fracture. This is the most common complication of impaction allografting. Femoral fracture or perforation is reported in 534% of published series on impaction allografting. (Figure courtesy of Aaron G. Rosenberg, M.D.)

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cases with more signicant bone stock deciency [14 16,20,24,25,29]. Intraoperative fractures generally occur during the impaction process when large hoop stresses are generated [16]. Cortical strut allografts [14,16] or mesh [15] should be used to reinforce femoral defects prior to impaction to reduce the risk of fracture. Postoperative femur fracture may occur proximally [16] or more distally near the stem tip [14]. It is suspected that many postoperative femoral fractures are, in fact, undisplaced, intraoperative fractures that were not appreciated during the surgery or on postoperative radiographs, as those radiographs can be difcult to interpret in the presence of overlying densities from cement, graft, stem, mesh, wires, and other hardware. Fractures have been associated with failure of the reconstruction [15,16] and with reoperation [1416,24,25,29]. Femoral perforation usually occurs intraoperatively while removing retained cement from the femoral canal. It can be treated successfully with cortical strut allografts [50]. Good exposure, lighting, and cement-removal instruments help decrease the likelihood of femoral perforation.

C.

Subsidence

Considerable controversy exists regarding stem subsidence in femoral impaction allografting. Gie et al. in their initial reports claimed that the wedge-shaped stem geometry may improve bone graft incorporation and healing by the compressive load produced by the subsiding stem [19]. It has therefore been suggested that subsidence of wedge-shaped stems does not necessarily indicate failure [14,15,51], in contrast to THAs designs that use roughened or precoated femoral stems [50,52,53]. What remains to be answered from these reports about the Exeter stem (Stryker-Howmedica-Osteonics, Rutherford, NJ) or ones similar to it is the amount of subsidence that can reasonably be considered efcacious. Eldridge et al. dened minimal subsidence less than 5 mm migration and moderate subsidence 10 mm [13]. While subsidence with roughened or precoated stems clearly indicates failure [20], subsidence of polished taper stems may not be the entirely benign or benecial process that early proponents of impaction allografting suggested [15]. Originally, it was felt that subsidence was a result of cold ow of the cement, and, as a result, the stem would self-tighten as it subsided. More recent studies indicate that this does not always happen. Masterson et al. reported high rates of cement fractures in stems that subsided [25]. This evidence suggests that cold ow of cement is not the mechanism of all cases of subsidence. A similar conclusion was reached in a study that used radiostereometric analysis [54]. Additionally, subsidence has been associated with thigh pain [13]

392

Table 1 Results of Femoral Impaction Allografting


a

Series

Stem

Min/mean follow-up (months)

Femur fracture, % (n)

Subsidence, % (n) and/or mean mm

Failed/ revised for loosening, % (n)

Dislocation, % (n)

Polished tapered stems Eldridge [13] Elting [14] Flugsrud [21] 79 67 10 18/30 7/31 12/42 NA 12/14 24/30 min 60 24/24 1/(1 72) 6/13 24/31 36/52 NA 5 (3/60) 0 (0/10)

23 (18/79)b 48 (27/56) 80 (8/10) 2.1

10 (8/79) 5 (3/60) 0 (0/10)

NA 3 (2/60) NA

Gie [15] Knight [24] Lind [34] Masterson [25] Tokgozoglu [26] Meding [16] Mikhail [55] Ornstein [28] Pekkarinen [29]

Cho et al.

van Biezen [31]

Exeter, CPT CPT Exeter-2, CPT-8 Exeter CPT Exeter Exeter Exeter CPT CPT Exeter Exeter Bi-Metricd Head-Neckd Exeter 58 31 87 35 9 34 43 18 36 21 11 21 41/60 7 (4/58) 16 (5/31) 2 (2/87) 17 (6/35) NA 24 (8/34) 5 (2/43) NA 25 (9/36) 33 (7/21) 64 (7/11) 10 (2/21)

79 (44/56) 50 (15/30) 2.3 2 (2/87)b 20 (7/35)c 0 (0/9) 44 (15/34) 86 (37/43) 2.5 86 (31/36) 2.7 90 (19/21) 2.7 100 (11/11) 5.6 81 (17/21) 7.2

5 (3/58) 0 (0/31) 0 (0/87) NA 0 (0/9) 6 (2/34) 3 (1/38) NA 6 (2/36) 5 (1/21) 9 (1/11) 0 (0/21)

5 (3/58) 13 (4/31) 6 (5/87) 6 (2/35) NA 3 (1/34) 8 (3/38) NA 3 (1/36) 14 (3/21) 0 (0/11) 5 (1/21)

Matte-nished, small-collared stems Boldt [32] Charnley Elite Plus 1.2 (1/79) 79 ,20/48 1.2 (1/79) 9 (7/79)e 3 (2/79)f

10 (8/79)

Impaction Bone Grafting at the Hip

Collared stems (varied surface nishes) Fetzer [33] Iowa Triumph Heritage Harris 13 6 4 3 30/67 12 (3/26) 4 (1/26)g

0 (0/26)

12 (3/26)

Roughened, collared stems Hostner [22] Karrholm [23] Leopold [20] Spectron EF Spectron Harris 24 22 29 3/3 24/30 48/63 NA NA 24 (6/25)

0.19 0.4 8 (2/25)

NA 0 (0/22) 12 (3/25)

NA NA 4 (1/25)

Dened as greater than or equal to 1 mm except as otherwise indicated. Greater than 5 mm. c Greater than 10 mm. d Proximally porous-coated, collared, titanium alloy stems using uncemented xation. e Greater than 4 mm, less than 6 mm. f Greater than or equal to 6 mm, less than or equal to 8 mm. g Less than 5 mm.

393

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Cho et al.

and later dislocation [25]. Therefore, the assertion that stems may subside an unrestricted distance, over any period of time, at any of several interfaces (cement/bone, stem/cement, or both), without meeting criteria for failure cannot be substantiated by studies that do not offer standardized functional or outcomes scores [15]. The length of time a stem may subside without failure is controversial [16]. One recent study used radiostereometric analysis to determine that most migration occurs during the rst 2 weeks and that some stems become stable after 5 weeks [27]. In addition, other recent clinical trials have reported smaller magnitudes of subsidence [32 34]. A possible explanation for these apparently improved results may involve the steps taken in preparation of the neo-endosteum [22,26], by better impaction technique [22], or graft material [26]. The reasons for stem subsidence in femoral impaction allografting are complex, but based on the good short- to intermediate-term results of recent series using an assortment of femoral prostheses, it seems that a rm impacted allograft is more important than stem design [32 34].

VI.

CLINICAL RESULTS OF IMPACTION ALLOGRAFTING

Results of femoral impaction allografting with short- to intermediate-term follow-up have been reported using an assortment of femoral prostheses by a number of different centers [13 16,20 26,28,29,31 34,55]. Table 1 summarizes pertinent endpoints from these clinical series.

VII.

SUMMARY

Femoral impaction allografting is an accepted alternative for revision of a failed femoral component with severe bone stock deciency. This procedure has a considerable learning curve, is technically demanding, and has numerous variables that need to be controlled in order to have a reasonable hope of clinical success. To date there have been no published reports from randomized, controlled clinical trials comparing different femoral stems or grafts for femoral impaction allografting. Investigators have shown equally good short- to intermediate-term results with a variety of femoral stems by a number of different centers. Until there are data available to compare the many variables in femoral impaction allograftingincluding graft type, impaction system, femoral stem type, and othersthe question will remain: Is femoral impaction allografting a system or a technique?

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1. Mulroy WF, Harris WH. Revision total hip arthroplasty with use of so-called secondgeneration cementing techniques for aseptic loosening of the femoral component. A fteen-year-average follow-up study. J Bone Joint Surg 1996; 78A:325 330. Weber KL, Callaghan JJ, Goetz DD, Johnston RC. Revision of a failed cemented total hip prosthesis with insertion of an acetabular component without cement and a femoral component with cement. A ve to eight-year follow-up study. J Bone Joint Surg 1996; 78A:982 994. Engh CA, Glassman AH, Grifn WL, Mayer JG. Results of cementless revision for failed cemented total hip arthroplasty. Clin Orthop 1988; 235:91 110. Lawrence JM, Engh CA, Macalino GE, Lauro GR. Outcome of revision hip arthroplasty done without cement. J Bone Joint Surg 1994; 76A:965 973. Moreland JR, Bernstein ML. Femoral revision hip arthroplasty with uncemented, porous-coated stems. Clin Orthop 1995; 319:41 50. Allan DG, Lavoie GJ, McDonald S, Oakeshott R, Gross AE. Proximal femoral allografts in revision hip arthroplasty. J Bone Joint Surg 1991; 73B:235 240. Blackley HR, Davis AM, Hutchison CR, Gross AE. Proximal femoral allografts for reconstruction of bone stock in revision arthroplasty of the hip. A nine to fteen-year follow-up. J Bone Joint Surg 2001; 83-A:346 354. Chandler H, Clark J, Murphy S, McCarthy J, Penenberg B, Danylchuk K, Roehr B. Reconstruction of major segmental loss of the proximal femur in revision total hip arthroplasty. Clin Orthop 1994; 298:67 74. McGoveran BM, Davis AM, Gross AE, Bell RS. Evaluation of the allograft-prosthesis composite technique for proximal femoral reconstruction after resection of a primary bone tumour. Can J Surg 1999; 42:3745. Malkani AL, Sim FH, Chao EY. Custom-made segmental femoral replacement prosthesis in revision total hip arthroplasty. Orthop Clin North Am 1993; 24:727 733. Malkani AL, Settecerri JJ, Sim FH, Chao EY, Wallrichs SL. Long-term results of proximal femoral replacement for non-neoplastic disorders. J Bone Joint Surg Br 1995; 77:351 356. Malkani AL, Paiso JM, Sim FH. Proximal femoral replacement with megaprosthesis. Instr Course Lect 2000; 49:141 146. Eldridge JD, Smith EJ, Hubble MJ, Whitehouse SL, Learmonth ID. Massive early subsidence following femoral impaction grafting. J Arthroplasty 1997; 12:535 540. Elting JJ, Mikhail WE, Zicat BA, Hubbell JC, Lane LE, House B. Preliminary report of impaction grafting for exchange femoral arthroplasty. Clin Orthop 1995; 319:159 167. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg 1993; 75B:14 21. Meding JB, Ritter MA, Keating EM, Faris PM. Impaction bone-grafting before insertion of a femoral stem with cement in revision total hip arthroplasty. A minimum two-year follow-up study. J Bone Joint Surg 1997; 79A:1834 1841.

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Boldt JG, Dilawari P, Agarwal S, Drabu KJ. Revision total hip arthroplasty using impaction bone grafting with cemented nonpolished stems and Charnley cups. J Arthroplasty 2001; 16:943 952. Fetzer GB, Callaghan JJ, Templeton JE, Goetz DD, Sullivan PM, Johnston RC. Impaction allografting with cement for extensive femoral bone loss in revision hip surgery. A 4-to 8-year follow-up study. J Arthroplasty 2001; 16:195 202. Lind M, Krarup N, Mikkelsen S, Horlyck E. Exchange impaction allografting for femoral revision hip arthroplasty. Results in 87 cases after 3.6 years follow-up. J Arthroplasty 2002; 17:158 164. Masterson EL, Busch CA, Duncan CP, Drabu K. Impaction allografting of the proximal femur using a Charnley-type stem: a cement mantle analysis. J Arthroplasty 1999; 14:59 63. Ullmark G, Linder L. Histology of the femur after cancellous impaction grafting using a Charnley prosthesis. Arch Orthop Trauma Surg 1998; 117:170 172. Masterson EL, Masri BA, Duncan CP, Rosenberg A, Cabanela M, Gross M. The cement mantle in femoral impaction allografting. A comparison of three systems from four centres. J Bone Joint Surg 1997; 79B:908-913. Chassin EP, Silverton CD, Berzins A, Rosenberg AG. Implant stability in revision total hip arthroplasty: allograft bone packing following extended proximal femoral osteotomy. J Arthroplasty 1997; 12:863 868. Aribindi R, Barba M, Solomon MI, Arp P, Paprosky W. Bypass xation. Orthop Clin North Am 1998; 29:319 329. Peters CL, Rivero DP, Kull LR, Jacobs JJ, Rosenberg AG, Galante JO. Revision total hip arthroplasty without cement: subsidence of proximally porous-coated femoral components. J Bone Joint Surg 1995; 77A:1217 1226. Capello WN. Impaction grafting plus cement for femoral component xation in revision hip arthroplasty. Orthopedics 1994; 17:878 879. Della Valle CJ, Bogner E, Desai P, Lonner JH, Adler E, Zuckerman JD, Di Cesare PE. Analysis of frozen sections of intraoperative specimens obtained at the time of reoperation after hip or knee resection arthroplasty for the treatment of infection. J Bone Joint Surg 1999; 81A:684 689. Feldman DS, Lonner JH, Desai P, Zuckerman JD. The role of intraoperative frozen sections in revision total joint arthroplasty. J Bone Joint Surg 1995; 77A:1807 1813. Goodman SB, Huene DS, Imrie S. Preoperative templating for the equalization of leg lengths in total hip arthroplasty. Contemp Orthop 1992; 24:703 710. Woolson ST. Leg length equalization during total hip replacement. Orthopedics 1990; 13:17 21. Hellman EJ, Capello WN, Feinberg JR. Nonunion of extended trochanteric osteotomies in impaction grafting femoral revisions. J Arthroplasty 1998; 13:945049. Thien TM, Welten MLM, Verdonschot N, Buma P, Yong P, Schreurs W. Acetabular revision with impacted freeze-dried cancellous bone chips and cemented cup. J Arthroplasty 2001; 16:666 670. Harris WH, McCarthy JC Jr, ONeill DA. Femoral component loosening using contemporary techniques of femoral cement xation. J Bone Joint Surg 1982; 64:1063 1067.

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Cho et al. Jazrawi LM, Della Valle CJ, Kummer FJ, Adler EM, Di Cesare PE. Catastrophic failure of a cemented, collarless, polished, tapered cobalt-chromium femoral stem used with impaction bone-grafting. A report of two cases. J Bone Joint Surg 1999; 81A:844 847. Duncan CP, Masterson EL, Masri BA. Impaction allografting with cement for the management of femoral bone loss. Orthop Clin North Am 1998; 29:297 305. Fowler JL, Gie GA, Lee AJ, Ling RS. Experience with the Exeter total hip replacement since 1970. Orthop Clin North Am 1988; 19:477 489. Berger RA, Kull LR, Rosenberg AG, Galante JO. Hybrid total hip arthroplasty: 7- to 10-year results. Clin Orthop 1996; 333:134 146. Oishi CS, Walker RH, Colwell CW Jr. The femoral component in total hip arthroplasty. Six to eight-year follow-up of one hundred consecutive patients after use of a third-generation cementing technique. J Bone Joint Surg 1994; 76A: 1130 1136. Franzen H, Toksvig-Larsen S, Lidgren L, Onnerfalt R. Early migration of femoral components revised with impacted cancellous allografts and cement. A preliminary report of ve patients. J Bone Joint Surg 1995; 77B:862 864. Mikhail WE, Wretenberg PF, Weidenhielm LR, Mikhail MN. Complex cemented revision using polished stem and morselized allograft. Minimum 5-years follow-up. Arch Orthop Trauma Surg 1999; 119:288 291.

50. 51. 52. 53.

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27
Revision of Total Knee Arthroplasty by Impaction Bone Grafting
Gary W. Bradley
ALTA Orthopaedics Santa Barbara, California, U.S.A.

I.

INTRODUCTION

Revision total knee arthroplasty can be technically challenging. Invariably there is bone loss, which at times is signicant, and the remaining bone is often extremely osteoporotic. Frequently, the bone loss is worse than had been anticipated before surgery. Relatively small, contained defects can be managed with a primary prosthesis. Larger defects can be lled with large amounts of cement. Cement with screw augmentation is an old technique, which is still indicated in certain circumstances. In North America, the most common method of replacing bone loss has been by metal wedges or blocks secured to special long-stemmed revision prostheses. These implants are designed to be cemented, and do not replace bone but actually, in most instances, remove more of it. The results of revision total knee arthroplasty are less predictable than primary knee replacement, and the technique of metal and cement augmentation creates a cycle of continued and ongoing bone loss. Custom implants have also been used for signicant bone loss, but lost bone is not replaced by bone but by implant so that in the event of failure yet further bone is lost. Thus, it is logical to replace bone loss with bone graft. Invariably bone loss is too great to be adequately replaced by autograft, so cadaveric allograft from bone banks is used. This can be as whole bone, parts of whole bones or impacted morselized allograft. Bone grafts can be used with polymethylmethacrylate (PMMA) cement [1 17].
399

400

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In revision total joint arthroplasty, bone grafting for protrusioacetabuli or medial wall defects was rst used and reported in the 1970s [18]. This technique has been most extensively studied and developed by Tom Slooff in Nijmegen, the Netherlands [19 21]. Slooff has also studied the basic science of morselized bone grafting and has vast and long-term clinical experience that reinforces the effectiveness of the technique. Professor Slooff can well be called the father of impaction allografting. The technique of impaction bone grafting was later adopted by Gie, Linder, and Ling on the femoral side of failed total hip arthroplasty [22]. Morselized bone grafting was rst used in the knee, to this authors knowledge, in the early 1980s. It was rst reported by Samuelson in 1988 [11] and then Whiteside in 1993 [15], and later, more denitively [16,17]. Both these authors used minimally impacted morselized graft without poly-methylmethacrylate cement. The early reports of morselized allograft consistently described satisfactory clinical results with good pain relief and function. In revision knee replacement, complications specic to bone grafting are minimal. As with other series of revision arthroplasties, the usual wound complications, patellar problems, and delayed fracture are reported. None of these are related to allografting. At ve-year follow-up, the percentage of successful revisions has generally been 90% or more [2 4,7,11,14,16,17]. Human histology has shown evidence of active new bone formation as early as 3 weeks. By 3 months extensive vascular inltration, osteoclastic resorption of dead graft bone and new osteoid with osteoblasts are evident. Extensive bone remodeling, resorption and new bone formation continues for between one and two years; histology after 37 months has shown continuing resorption and new bone formation [16,21,23,25].

II.

INDICATIONS

The immediate appeal of this technique is replacement of lost bone. With minimal bone loss, traditional modications of primary arthroplasty techniques can be used with conventional, primary components, minimal bone graft, and/or PMMA cement. In the elderly, frail, and low-demand individuals with moderate to even extensive bone loss, conventional revision techniques using metal wedges and blocks and cement can also be employed. Thus, small amounts of even autogenous impacted morselized bone graft can be used in any revision or primary knee arthroplasty with more than usual bone loss or extremely weak or porotic bone [24,26,27]. However, the technique has the most to offer when there is signicant bone loss, especially in a young or active individual in whom the

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surgeon wishes to avoid the potential cycle of repeated revision and everincreasing bone loss. The technique of impacted morselized bone grafting can be used in infection [2]. Appropriate antibiotics can be placed in bone cement and graft. I have not found combining bone graft and cement useful but have used impacted morselized bone graft impregnated by appropriate antibiotics to salvage an infected knee arthroplasty. The recommended technique is two-stage revision. The rst stage involves removal of all implants and cement, extensive debridement of soft tissues and closure over antibiotic impregnated cement beads, spacers, or Prostalac-type implants. The second stage takes place after a delay of 4 6 weeks with subsequent debridement and reimplantation of cementless components utilizing antibiotic impregnated morselized bone graft. There is concern that antibiotics on bone graft may not be effective, as bone graft is dead. However, clinical results have been satisfactory with this technique. There is a paucity of delayed histology on infected cases.

III.

TECHNIQUE

The aim of revision total knee arthroplasty is a solid and stable construct and satisfactory range of movement. Prerequisites to this are alignment, recreating the joint line, stability, and restoration of lost bone. In revision total knee arthroplasty alignment, position of joint line, stability, and replacement of lost bone are interrelated. If these are not adequately addressed, the revision is destined for a poor result and possibly early failure. Alignment is a complex issue and often difcult to achieve whether intramedullary or extramedullary guide systems are used. In revision knee arthroplasty with signicant bone loss, intramedullary alignment will be obtained from stemmed implants. Instability in revision knee arthroplasty is invariably related to bone loss or malposition of the joint line. True ligamentous insufciency is unusual in either primary or revision knee arthroplasty. Clinically, malposition of the joint line manifest by patella alta is associated with an increased incidence of diffuse radiolucent lines in primary knee replacement [29]. Elevation of the joint line by more than 8 mm is associated with decreased movement and functional knee scores and increased pain and incidence of manipulation. Ultimately, revision is associated with to malposition of the joint line. Another study found that the best knee scores were when the joint line was within 3 mm of the anatomical normal [30]. In cadavers, elevation of the joint line by !5 mm causes mid exion laxity whereas lowering the joint line by !5 mm results in mid-exion tightening. Any change in joint line by !5 mm also caused, in these cadaver studies, varus/ valgus instability [33]. Restoration of joint line by replacing lost bone is

402

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important as a malposition causes instability or poor movement and function and, ultimately, arthroplasty failure. Bone loss manifest by malposition of the joint line is a real clinical problem. In a series of over 100 knee replacements performed by elite surgeons with extensive revision experience, the joint line was changed by .5 mm in nearly 80% of cases [34]. The location of the joint line in a normal knee has been variably reported to be between 20 and 40 mm proximal to the tibial tubercle, between 10 and 20 mm proximal to the bular head, and 25 33 mm distal to the medial femoral epicondyle. There is an even more variable relationship to the lateral femoral condyle. The medial femoral epicondyle is the most consistent landmark, being most easily located and having the least variation among individuals. This distance is slightly greater in large or male patients and relatively smaller in small or female patients. The distance to the posterior femoral condyle from the medial femoral epicondyle is generally greater than the distance to the distal femoral condyle. This distance is, on average, between 25 and 30 mm [31 33]. These observations can be translated to surgical technique in the revision knee arthroplasty. Preoperative templating and measurements of removed implants are helpful in determining revision implant size. A common error in revision knee arthroplasty is downsizing the femoral component to obtain a better t on the distal femur deformed by signicant bone loss. The recommended surgical technique is to prepare the tibia rst, then to stabilize the distal femur by using a trial component with intramedullary alignment rod and pins to restore proper femoral size and rotation. Only after achieving exion balance is extension balance addressed. Flexion balance relates to femoral component size and tibial height, both of which affect the position of the joint line and are, in turn, inuenced by replacement of lost bone. Flexion balance is also related to rotation and tibial alignment. Extension balance is related to alignment of both components and position of the joint line. Technical performance of revision surgery can be divided into ten steps: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Surgical approach Soft tissue debridement Implant removal Bone preparation Graft preparation Graft placement Implant placement Graft augmentation Final impaction of components Closure

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Surgical approach is dictated by surgeon preference and unique problems such as contracture or deformity and previous surgical approaches. Soft tissue debridement varies from highly extensive in infection to minimal in straightforward revisions without signicant polyethylene wear or metallosis. There is, invariably, in revision knee arthroplasty, extensive scarring in the suprapatellar region, the medial and lateral gutters, and behind the patellar tendon. There are a variety of techniques for implant removal. Requirements for bone preparation are equally variable, but the principal is to remove all soft tissue from the bone bed to be grafted. Even a sclerotic bone bed is well vascularized and will contribute to bone healing [12,21]. It is not necessary to remove sclerotic bone down to cancellous. Attempts to remove all sclerotic bone just create an even more daunting defect to reconstruct. The aim of graft preparation is to cancellous or cortico-cancellous bone chips of between 3 and 5 mm. Most experience is with cleaned and fresh frozen bone obtained from reputable bone banks. In the United States the American Association of Tissue Banking has rigid requirements. It is recommended that all bone be obtained from regulated bone banks. Donor bone comes in various forms usually as femoral heads or 5 10 mm cancellous and cortico-cancellous pieces. In either case, any of a variety of bone mills can be used to obtain the 3 5 mm pieces of bone to be impacted. The frozen bone should be thawed before milling. Soaking the graft in antibiotic solution has no adverse effect on ultimate graft viability. It is important to obtain an adequate amount of bone graft. In most knee revisions two to three morselized femoral heads or two to three 90 cc bags of cortico-cancellous blocks will be used. Graft preparation can be performed on the back table by an assistant or technician while the revision is going on. Initial graft placement consists of lling all contained defects with impacted bone. As with many orthopedic surgical techniques, the amount of impaction can be described as just enough, i.e., enough to rmly impact the graft and create a sound construct without fracturing the underlying bone. If a sclerotic shell is present, it often is quite thin and fractures easily. If there is no shell, cancellous bone will be exposed. This merely requires rm impaction of more bone. The original impaction techniques for revision knee arthroplasty, described by Samuelson and Whiteside [11,15 17], relied on minimal impaction but used larger pieces of bone. From the extensive work of Slooff it is apparent that greater impaction will result in better structural stability without impairing graft incorporation [21]. Conventional tamps and a small to mid-size mallet can be used for impacting graft. A one-handed auto impaction device (Finsbury Instruments, Ltd. Leatherhead, Surrey, United Kingdom) improves the consistency of impaction grafting. This device, originally developed for cement removal in revision hip

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arthroplasty, greatly facilitates the operative technique by freeing up the surgeons other hand to place the morselized graft accurately. It also provides a consistent and predictable amount of force to the graft (Fig. 1). Uncontained or open defects can be controlled by using wire mesh or, rarely, fracture plates [2,6]. After all contained defects have been lled, either cutting guides or trial implants, depending upon the surgeons preference and experience, can be positioned. If there is a large endosteal defect, it should be grafted using tapered stems as tamps as in the proximal femur as described by Gie et al., before cutting guides or trial implants are inserted. It is imperative that the guides or trials be accurately aligned and reasonably well xed. At this time, stability and range of motion can be tested and the distance from the medial femoral epicondyle to the joint line can be measured as described above. It is recommended that intraoperative x-rays be obtained once a satisfactory construct has been created. If there is signicant bone loss in a relative capacious canal, the construct may appear satisfactory individual component may be malaligned. This seems to be a bigger problem in the lateral or exion/extension than in the AP view. Thus, both an AP and lateral x-ray should be obtained intraoperatively at this stage (Fig. 2). Once the components are positioned accurately, uncontained defects can be lled with morselized bone. At this point the actual implants are

Figure 1 One-handed automatic impaction device and selection of attachments. Various tamps, cernent removing chisels, and a pin holder are shown.

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Figure 2 Intraoperative photos and follow-up x-rays. (A, B) The distal femoral defect. The tibia bas already been reconstructed. (C) Placing bone endosteally to stabilize the short stem. An intramedullary rad is shown being used to control bone graft placement. (D) Trial component in position after contained defects have been lled with impacted ball. The remaining defect is seen. (E) Final position of actual implant with impacted bone seen to ll the previous defect. Additional bone is being placed and impacted beneath the ange superiorly. (F) Six-year postoperative lateral x-ray showing nal position in slight exion. Nonetheless, continued good function (Knee Society Knee Score 155). (G) Six-year postoperative A-P x-ray.

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Figure 2

Continued.

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Figure 2 Continued.

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Figure 2

Continued.

placed but not fully seated. The bone is rmly impacted, completely lling all defects. The most difcult area to ll is the posterior femoral condyle. The nal 3 5 mm of graft impaction is achieved when the denitive prosthesis is nally implanted. Range of motion and stability are now tested. If there is instability or poor mobility, alignment and position of the joint line should be remeasured. Repeat intraoperative x-rays might be indicated. Routine wound closure with or without drains and splinting or placement in a continuous passive motion device ensues. Minimal weight bearing with two sticks or crutches is allowed for the rst month. During the second month, weight bearing, still with two sticks or crutches, is allowed up to a maximum of 50%. During the third month, weight bearing with

Revision of Total Knee Arthroplasty

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two sticks or crutches is allowed as tolerated. Depending upon the extent of grafting, this time might be shorter but is more often longer, to a total of 4 months using two sticks or crutches.

IV.

CLINICAL EXPERIENCE

Morselized impaction bone grafting was rst used by this author in 1992 for revision of a chronically infected hinge arthroplasty in an 85-year-old woman. She had been on long-term suppressive antibiotics for 10 years with progressive bone loss. Although the infection appeared to be controlled, the bone loss was not, and she faced either an amputation or a major reconstructive procedure. Because of extensive bone loss, the usual (for that time) custom devices were not deemed appropriate. Reconstruction was undertaken with a distal femoral allograft, and the morselized impacted bone grafting was used for the proximal tibia. This was treated as a chronically infected arthroplasty in three stages, with interval debridement between implant removal and reconstruction. Postoperative treatment was as described above. She made satisfactory progress and was living independently 9 years later with a satisfactory construct and a satisfactorily functioning knee (Fig. 3). Initially this technique was used only in signicant bone loss and further bone loss had to be avoided. It has evolved so that it is now my preferred technique for all but the most straightforward knee revisions. A standard LCS revision component (DePuy, Warsaw, IN) was used in all but three knees. This revision implant has a xed stem that is proportional between sizes. The femoral component stem varies from 9.5 to 10.5 cm in length with a base diameter of two centimeters. The tibial component also has a xed stem varying between 8.5 and 10.5 cm long with a base diameter between 2 and 2.5 cm. The tibial component has two platform thicknesses of 5 and 15 mm. Both components are porous coated on their undersurface and on the proximal portion of the stem only. The stems taper slightly, forming an elongated cone. In all instances, a rotating platform polyethylene insert was used with either standard or deep dish conguration. In four patients the standard LCS revision components were not used. In one of these patients, described above, a custom LCS femoral component with a longer femoral stem was used to stabilize a whole distal femoral allograft in the knee in which the proximal tibia was replaced using impacted graft. In two patients Coordinate (DePuy) long-stemmed femoral revision components were used with impacted allograft to reconstruct the distal femur, which had failed secondary to supracondylar fracture. In a fourth patient an AMK prosthesis (DePuy) was left in situ as the distal femur was grafted with 150 cc of morselized impacted bone. Failed patellar components were handled differently, and this technique was not used on any patella. Thirty-nine knees have been revised using this

410 Bradley

Figure 3 Preoperative and postoperative x-rays of 85-year-old having reconstruction for chronically infected hinged prosthesis: (A) preoperative A-P; (B) preoperative lateral; (C) 7-year postoperative A-P; (D) 7-year postoperative lateral.

Revision of Total Knee Arthroplasty

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Figure 3 Continued.

412

Bradley

technique. All knees received at least 90 cc of morselized impacted bone graft, roughly equivalent to one femoral head. Three knees were lost and two died before one-year follow-up. Four knees in this series are known to have failed. In two knees a partial femoral head without polymethylmethacrylate cement was used for structural augmentation in conjunction with impacted morselized graft. One whole distal femur was used (with PMMA) in a knee in which morselized impacted graft was used on the tibial side. In ve knees PMMA augmentation was used in conjunction with morselized bone graft. All patients were advised, preoperatively, that a large bone graft was to be used, that this was a biological process, and that some graft resorption might be expected. They were furthermore advised that the purpose of the procedure was to rebuild lost bone and that a subsequent, even early, re-revision might be necessary. The average age of these patients was 72 years (range 39 92 years). Six knee replacements had been infected. The index procedure was the second or, in one case, the third stage of a staged reconstruction. One failure was by aseptic loosening. This was in a knee in which the morselized graft was augmented with bone cement. The loose component was converted to a conventional long-stem semi-constrained cemented prosthesis. This is the only known instance of loosening in this series. The second failure was following reconstruction for a supra-condylar femur fracture. This failure mode was nonunion. Exploration at the time of repair of non-union showed, histologically conrmed, impressive incorporation of impacted bone graft. The two other failures were by tibial rotating polyethylene spin-out. These both required open reduction but have ultimately achieved satisfactory function. All patients followed for more than one year have beneted from the procedure. The four patients requiring reoperation have achieved satisfactory function in the revised knee. The Knee Society clinical rating system was used. This divides knee and patient function scores [37]. These scores were tabulated separately with their deductions and then added to form a nal score. Without deductions the maximum obtainable score was 200 points. With deductions it is possible to obtain a negative score. All negative scores were recorded as 0 points. Using this application of the Knee Society rating system, the preoperative knee scores ranged from 0 to140 points (average 60 points). Postoperatively, the scores ranged from 102 to 198 points (average 147 points). The average improvement was 87 points. All patients had a minimum improvement of over 20 points. Patients were categorized, applying Charnleys hip classication of general disease to the knee: Category A, unilateral knee involvement only; Category B, unilateral knee involvement with a symptomatic opposite knee or other joint; and Category C, multiple joint arthritis or signicant medical inrmity [38]. According to these groups the patients in Category A beneted most from the procedure, showing an average improvement in Knee Society knee scores of over 90 points. Follow-up radiographs have demonstrated no further signicant bone

Revision of Total Knee Arthroplasty

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loss. Several knees have measurable tibial subsidence of ,1 cm. Femoral subsidence is difcult if not impossible to assess accurately. Sclerotic lines around uncemented femoral and tibial stems are relatively common but do not progress with time. Mild cortical hypertrophy has been seen occasionally in tibiae and femurs but was not clinically signicant.

V.

CONCLUSIONS

Bone loss is inevitable in patients undergoing revision total joint surgery. This bone loss is often found intra-operatively to be greater than anticipated preoperatively and can be quite signicant in total knee revision surgery. Morselized impacted bone grafting has been used in a variety of contexts and justies considerable condence. Incorporation of bone graft has been substantiated by several radiographic methods, histology, and radiostereophotometric analysis [9,12,20,21,25,39]. Histology provides the only absolute evidence of graft viability. It is not feasible to assess an entire graft histologically, so it is possible that signicant portions of these grafts remain dead and are not replaced with host bone. Nonetheless, in this and other series, signicant benet has been obtained from bone grafting: bone has revascularized and incorporated and midterm clinical results are more than satisfactory. There appears to be some longevity and stability to these constructs. This authors experience and the experience of others supports the continuing use of impacted morselized bone grafting techniques in patients with large bone defects undergoing total knee revision arthroplasty. The basic principles of knee revision surgery must be scrupulously adhered to if a satisfactory result is to be expected. Alignment, placement of joint line, stability, and replacement of bone loss are imperative to achieve structural stability and satisfactory kinematics. Revision total knee arthroplasty can be divided into 10 steps: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Surgical approach Soft tissue debridement Implant removal Bone preparation Bone graft preparation Initial graft placement, lling contained defects Preliminary implant placement Final graft placement, augmentation of uncontained defects Final implant placement/impaction Wound closure

If these 10 steps are meticulously followed, a satisfactory and long-lasting construct can be anticipated.

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REFERENCES
1. 2. 3. 4. 5. 6. 7. Aglietti D, Buzzi R, Scrobe F. Autologous bone grafting for medial tibial defects in total knee arthroplasty. J Arthroplasty 1991; 6:287 294. Bradley, GW. Revision total knee arthroplasty by impaction bone grafting. Clin Orthop 2000; 371:113 118. Chandler HP. Structural bone grafting about the knee. Orthopedics 1998; 21:1044 1047. Dorr LD, Ranawat CS, Sculco TP, et al. Bone graft for tibial defects in total knee arthroplasty. Clin Orthop 1986; 205:153 159. Elia EA, Lotke PA. Results of revision total knee arthroplasty associated with signicant bone loss. Clin Orthop 1991; 271:114 121. Garino JP. The use of impaction grafting in revision total knee arthroplasty. J Arthroplasty 2002; 17:94 97. Heyligers IC, Van Haaren EH, Whisman PIJM. Revision knee arthroplasty using impaction grafting and primary implants. J Arthroplasty 2001; 16:533 537. Laskin RS. Total knee arthroplasty in the presence of large bony defects of the tibia and marked knee instability. Clin Orthop 1989; 248:66 69. Lindstrand A, Hansson U, Toksvig-Larsen S, Ryd L. Major bone transplantation in total knee arthroplasty. J Arthroplasty 1999; 14:144 148. Lotke PA, Garino JP, Lonner JH, Nelson CL. Impaction grafting in revision total knee arthroplasty: use of wire mesh for containment. AAOS Annual Meeting, Orlando, FL, Scientic Exhibit No. SE033, 2000. Samuelson KM. Bone grafting and non-cemented revision arthroplasty of the knee. Clin Orthop 1988; 226:93 101. Ullmark G. Morselized impacted cortico-cancellous bone allografts in revision surgery for endoprosthetic loosening with osteolysis. Acta Universitatis Upsaliensis, Uppsala, Sweden, 2001. Van Loun CMH, de Waal Malejit MC, Buma P, et al. Autologous morselized bone grafting restores uncontained femoral bone defects in knee arthroplasty. J Bone Joint Surg 2000; 82-B:436 444. Van Zyl AA, Botha PJ. Bone impaction grafting in the total knee replacement. J Bone Joint Surg 2002; 82-B(suppl 11):152. Whiteside LA. Cementless revision total knee arthroplasty. Clin Orthop 1993; 286:160 167. Whiteside LA. Results of cementless revision total knee arthroplasty. In: Engh G, Rorabeck C, eds. Revision Total Knee Arthroplasty. Baltimore: Williams and Wilkins, 1997. Whiteside LA. Morselized allografting in revision total knee arthroplasty. Orthopedics 1998; 21:1041 1043. McCollum DE, Nunley JA, Harrelson JM. Bone grafting in total hip replacement for acetabular protrusion: J Bone Joint Surg 1980; 72A:248 252. Sloof TJJH, Schimmel J, Buma P. Cemented xation with bone grafts. Orthop Clin North Am 1993; 24:667 672.

8. 9. 10.

11. 12.

13.

14. 15. 16.

17. 18. 19.

Revision of Total Knee Arthroplasty 20. 21.

415

22. 23. 24. 25. 26. 27. 28. 29. 30.

31. 32. 33. 34. 35. 36. 37. 38. 39.

Sloof TJJH, Huiskes R, Van Horn J, Lemmens AJ. Bone grafting in total hip replacement for acetabular protrusion. Acta Orthop Scan 1984; 55:593 596. Sloof TJJH. Viability of acetabular bone bed. In: The Incorporation Process of Morselized Bone Graft. CIP-Gegevens Koninklijke Bibliotheek, Den Haag, The Netherlands, 1998. Gie GA, Linder L, Ling RSM, et al. Impacted cancellous allograft and cement for revision total hip arthroplasty. J Bone Joint Surg 1993; 75B:14 21. Ullmark G, Obrant KJ. Histology of impacted bone-graft incorporation. J Arthroplasty 2002; 17:150 157. Altchek D, Sculco TP, Ralins B. Autogenous bone grafting for severe angular deformity in total knee arthroplasty. J. Arthroplasty 1989; 4:151 157. Van der Donk S. Incorporation of morselized balle grafts: a study of 24 acetabular biospy specimens. Clin Orthop 2002; 396:131 141. Franceschina MJ, Swienckowski JJ. Correction of varus deformity with tibial ip autograft technique in total knee arthroplasty. J. Arthroplasty 1999; 14:172 174. Windsor RE, Insall JN, Sculco TP. Bone grafting of tibial defects in primary and revision total knee arthroplasty. Clin Orthop 1986; 205:132 136. Scuderi GR, Insall JN, Haas SB, et al. Inlay autogenic bonegrafting of tibial defect in primary total knee arthroplasty. Clin Orthop 1989; 248:93 97. Meding JB, Keating EM, Ritter MA, Farris PM. Total knee arthroplasty after high tibial osteotomy. Clin Orthop 2000; 375:175 184. Lyons ST, Hofmann AA, Camargo M, et al. Restoration of the joint line based on the distal femur in revision total knee arthroplasty. AAOS Annual Meeting, Scientic Exhibit No. SE032, 2000. Clarke HD, Scott WN. Instability after major joint replacement. Orthop Clin North Am 2001; 32(4). Grelsamer RP. Patella baja after total knee arthroplasty: is it really patella baja? J Arthroplasty 2002; 17:66 69. Martin JW, Whiteside. The inuence of joint line position on knee stability after condylar arthroplasty. Clin Orthop 1990; 259:146 156. Partington PF, Sawhney J, Rorabeck CH, Barra RL, Thoore J. Joint line restoration after revision total knee arthroplasty. Clin Orthop 1999; 367:165 171. Grifn FM, Math K, Scuderi GR, et al. Anatomy of the epicondyles of the distal femur. J Arthroplasty 2000; 15:354 359. Robbins GM, Masri BA, Garbuz DS, Duncan CF. Instability after major joint replacement. Orthop Clin North Am 2001; 32(4). Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop 1989; 248:13 15. Charnley J. The long-term results of low-friction arthroplasty of the hip performed as a primary intervention. J Bone Surgery 1972; 54B: 61 76. Tokgozoglu A, Aydin M, Atilla B, Caner B. Scintigraphic evaluation of impaction grafting for total hip arthroplasty revision. Arch Orthop Trauma Surg 2000; 120:416 419.

28
Revision Knee Arthroplasty with Impaction Bone Grafting
Gosta Ullmark
Centre for Research and Development Lanssjukhuset, Gavle, Sweden

I.

BIOMECHANICAL ASPECT

The same principles apply to the knee as to the hip. Large bone chips with the fat washed out and a very rm impaction is recommended. Stable metal mesh must safely cover any defect before impaction grafting. Only long-stemmed prostheses are recommended with impaction grafting. There have to be dedicated instruments for any impaction grafting except in small contained areas.

II.

SURGICAL METHOD

A method is described using a dedicated instrument set adapted to the Link Rotation Knee (Waldemar Link GmbH & Co, Hamburg, Germany) (Fig. 1). The loose prosthesis, any cement, brous membrane, and debris are completely removed. The cavitatory bone defects are reamed to achieve continuity with the femoral and tibial medullary canals. The sclerotic inner surfaces are roughened with a cutter. Starting with the tibia, the medullary canal is occluded with a rm tting acrylic plug (Mitab, Scandimed, Sjobo, Sweden). The centralizing device screwed into the plug is left in place during the impaction grafting. The morselized bone graft close to the plastic plug is packed with a distal impactor and more proximally only lightly packed with this impactor. The tibial impactor on the centralizer down is used to pack bone into the cavity to produce a rm
417

418

Ullmark

Figure 1 knee.

Impaction instruments for knee bone grafting dedicated to Link rotation

impaction grafting (Fig. 2). Proximally, additional graft is impacted around the end of the tibial impactor using the end impactor. The centralizing rod is now detached. The tibial impactor is pulled out and a small suction catheter is placed at the bottom of the impacted medullary canal. A cement gun with a conical end is used to ll the cavity retrograde. The tibial prosthesis component is inserted with the cement at low viscosity. The cavity in the distal femur is prepared in the same way. A femoral impactor is used over the same centralizer as in the tibia. The distal end of the femur can be prophylactically wired before hard impaction. The intracondylar area of the femur is impacted by the condylar impactor followed by end impaction. Before cementation of the femoral stem, alignment and appropriate ligament tension is assessed by trial reduction of the femoral impactor against the already cemented tibial component. In cases when only partial bone grafting is needed, often in one of the tibial condyles, a tibial titanium mesh is screwed through its anges to the inside of the defective tibial condyle (Fig. 3). After cutting the mesh to the appropriate height, the tibial medullary cavity is reamed to t the tibial impactor. This impactor is inserted to the appropriate level followed by impaction morselized bone grafting

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Figure 2 Tibia impaction instrument, impacted in a tibia graft bed.

Figure 3 Tibia titanium mesh to convert noncontained proximal tibia bone defect to a contained defect, followed by impaction grafting.

WEB COLOR

420

Ullmark

between the titanium mesh and the tibial impactor using the end impactor. This impaction procedure is followed by a routine cementing of the prosthetic tibial component. Partial knee impaction has been described in the literature [1].

III.

RESULTS

We have been impaction grafting revision total knee arthroplasties (TKA) since 1993 [2] and have results from cementing prostheses into completely grafted knees in nine cases (Fig. 4). Partial bone grafting was performed in 11 cases. The follow-up period for these cases is 1 8 years. One was revised. The reason for revision was fracture of the femoral component. On exploration, there was metallosis and newly formed scalloping around the proximal lateral aspect of the femoral component. In other areas the prosthesis and cement was well xed to bleeding bone in areas that had been grafted. The revision was carried out by further impaction grafting. The clinical results in all other cases are good or excellent. There are no radiographic or clinical signs of prosthetic loosening or subsidence. Two cases have been histologically assessed. There was evidence of bone healing in both.

Figure 4 (Left) Major osteolysis and a loose Guepar prosthesis. (Right) 28 months after revision TKA including impaction grafting.

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When a stemmed TKA is mechanically loose with severe bone loss, even arthrodesis may be unreliable. In such cases, revision TKA with impaction grafting of fresh frozen morselized and fat-reduced bone allograft is a demanding but successful method. However, it is necessary to use stemmed knee prostheses and dedicated knee impaction instruments. Furthermore, there is a learning curve for this kind of revision surgery. At our center we are happy with the method and continue to practice it whenever there is mechanical loosening of a knee replacement with severe osteolysis.

REFERENCES
1. 2. Benjamin J, Engh G, Parsley B, Donaldson T, Coon T. Morselized bone grafting of defects in revision total knee arthroplasty. Clin Orthop 2001; 392:62 67. Ullmark G, Hovelius L. Impacted morsellized allograft and cement for revision total knee arthroplasty. Acta Orthop Scand 1996; 67:10 12.

29
Revision Knee Arthroplasty with Impaction
I. C. Heyligers , E. H. van Haaren, and P. I. J. M. Wuisman
Vrije Universiteit Medical Center Amsterdam, The Netherlands

I.

INTRODUCTION

Loss of bone stock around loose total joint replacement is a serious problem in revision surgery. It can be addressed by different techniques. Combinations of metal and cement can be used to replace the lost bone, but this makes subsequent revision much more difcult as there will be even greater loss of bone stock loss. Replacement of the bone lost by bone solves this problem. In revision hip arthroplasty, good clinical results have been reported when impacted bone particles have been used to treat bone loss [13]. These particles are rmly impacted layer by layer with special instruments, and a primary stem and cup are cemented into this bed of impacted bone. Segmental defects are contained with metal mesh with cerclage wires and screw xation to restore the anatomy. Bone graft is impacted against the metal mesh. Following good results with this procedure in revision hip surgery, we adapted the technique to treat bone loss around loose knee implants [4]. Special instruments were designed and manufactured to impact the bone particles layer by layer. Primary knee replacement prostheses (Kinemax, StrykerHowmedica-Osteonics) were cemented into this bone bed. In this chapter we describe the technique and clinical results.

Current afliation: Atrium Medical Center, Herleen, The Netherlands

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II. A.

MATERIAL AND METHODS Bone Banking Procedures

We use donor bone from our bone bank. This contains femoral heads processed to the standards of the American Association of Tissue Banks (AATB) [5] and the European Association of Musculo Skeletal Transplantation (EAMST) [6]. All donors give informed consent. They are rst screened by questionnaire about their medical, social, and sexual history and are subsequently interviewed by a medical doctor. The questionnaire in the donors own language followed the guidelines of the AATB and EAMST. After the questionnaire, a thorough physical examination is performed and routine blood tests carried out. Donors are screened for syphilis, HBV1 and 2, and HTLV type 1 and excluded if the erythrocyte sedimentation rate (ESR) is raised (normal values: 0 15, males ,50 years; 0 20, males .50 years and females ,50 years; 0 30, females .50 years). All donors are screened again for HIV1 and 2, syphilis, HBV, HCV, and HTLV1 6 months after the rst test to exclude any seroconvertors. Bacterial contamination of the femoral head is assessed by culture and histopathology. Swabs from the corticocancellous bone and a part of the capsule are taken for aerobic and anaerobic culture. Swabs are incubated in Stuarts medium and subcultured onto blood agar and culture broth for at least 5 days. A 1 cm3 core biopsy from the femoral head and a sample of synovium is examined histologically. B. Surgical Technique

All implants, cement, and interfaces are removed and a thorough debridement is performed. As much host bone as possible is saved. Preoperatively all necessary diagnostic investigations are used to rule out infection. During surgery, frozen sections, Gram stains, and cultures are also performed to exclude infection. If there is an infection, we always perform a two-stage procedure. The bone of the distal femur, the patella, and the proximal tibia are cleaned and carefully inspected to assess bone loss, cracks, fractures, and bone quality. When bone can be harvested from the same knee joint without interfering with the planned surgery, for example, when a unicompartmental prosthesis is revised, we mix autograft with donor bone. The cancellous bone is cut with a large nibbler into pieces of about 7 mm diameter. When a segmental defect needs to be treated, we use the same technique as in revision hip arthroplasty. Metal mesh is cut to size and xed with self-tapping screws or cerclage wires. The bone is then impacted against the metal mesh. In revision hip surgery we have a great deal of experience with this technique, but in revision knee surgery we have used mesh only once so far. A restrictor is xed rmly into the medullary canal of the femur and the tibia. With

Revision Knee Arthroplasty with Impaction

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special instruments we measure the diameter of this restrictor into which a central guide wire is xed. Cannulated tamps are inserted over this guide wire (Fig. 1). The instruments used to impact the bone particles go up in increasing sizes to nish with a nal implant resembling the cemented prosthesis. The size of the implants is based on radiographic measurements and the trial tted during the operation. The shape of the implants is based on the design of the denitive prostheses and impacts the bone particles tightly. The femoral impactors have a valgus angle of 78. The tibial component is placed in neutral in the coronal plane with a posterior slope of about 38 (Figs. 2, 3). The bone particles are impacted layer by layer with enough force to produce a dense mass of well-compressed bone. The last impactor leaves the bone bed in the desired shape for the denitive cemented prosthesis. The impactors are designed to allow an extra 2 mm for the cement mantle. Joint line landmarks are identied to restore the joint line as close as possible to the anatomical position. Primary knee prostheses without long stems (Kinemax, Stryker-Howmedica-Osteonics, Limerick, Ireland) are implanted. All implants are xed with gentamicin bone cement (Simplex, StrykerHowmedica-Osteonics, Limerick, Ireland). In primary knee replacements, we do

Figure 1 Special instruments that were designed for impaction of the femur and the tibia. Over a central rod, which is xed to a plug in the femoral and tibial canal, impactors with decreasing dimensions are used to impact the bone particles layer by layer. (From Ref. [4].)

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Figure 2 Impaction of the femur. A sliding hammer is used to impact the donor bone with impactors which are designed in such a way that the desired form is created with an extra 2 mm into account for cement xation of the nal femoral implant. (From Ref. [4].)

not resurface the patella and rarely do so in revisions. We always debride degenerate cartilage and remove all osteophytes from the patella. Every effort is made to centralize the patella in the trochlea, and we often perform a lateral retinacular release. Depending on the primary stability and extent of bone loss grafted, the knee is immobilized in a cast for up to 3 months, during which isometric quadriceps exercises are performed. Knee movement is started after this. Depending on the initial bone loss and the amount of donor bone grafted, we do not permit full weight bearing for a minimum of 3 months after surgery. C. Patients

Eleven knee revisions were performed in nine patients (Table 1). The mean age was 75 years, with a range of between 62 and 87 years. There were seven women and two men. Six unicompartmental knee prostheses were removed, ve from the medial side and one from the lateral. Four total knee replacements were revised, including one with long intramedullary stems in a patient who already had undergone two knee revisions before on the same side (patient No. 1). In one case, the femoral component alone was revised. Because of suspicion of

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427

Figure 3 Impaction of the tibia. A sliding hammer is used to impact the donor bone layer by layer with canulated impactors for cement xation of the tibial implant. (From Ref. [4].)

infection, a two-stage procedure was performed in three cases. A medial parapatellar approach was used in all operations. In one case, osteotomy of the tibial tuberosity was performed. Bone defects of the distal femur and the proximal tibia were described using the classication of the Anderson Orthopaedic Research Institute [7] (Table 2). During the revision operations all patients had a primary total knee prosthesis implanted with standard stems (Kinemax, Stryker-Howmedica-Osteonics, Limerick, Ireland) into impaction grafted donor bone. A posterior stabilized insert was used four times and a conventional posterior cruciate retaining seven. A patellar component was

428

Table 1
Bone loss Implanted

Overview of Patients Treated with Impacted Bone Grafting in Revision Knee Arthroplasty
Bone graft

Patient no., sex, age Removed Revision TKP right (long stems) F2b T2b F3 T2b Femur Tibia Femur Tibia Patella No

F.U.

Insert 21 mm

Femur 2 femoral head

Tibia 2 femoral head

1: F, 73 y

212 Y

2: M, 62 y

3Y

Medium

21 mm

1/2 femur head

1/2 femur head

3: M, 87 y F2a T2b

312 Y

Cemented TKP right and patella component Unicompartmental medial left

Posterior Extra small stabilized small Posterior Large stablilized large Medium Large

No

10 mm

Auto- and allograft 1/2 femur head 12 mm 10 mm 1 femur head Autograft Autograft

4: F, 78 y F2a F1a T2a T2a Unicompartmental medial left Unicompartmental medial right

312 Y

Auto- and allograft 1/2 femur head Autograft Primary TKP Small natural No small Cemented Medium natural No medium

Heyligers et al.

412 Y

5: F, 77 y F2b T2b Small No 18 mm 1/2 condylblock

412 Y F2a T2a Medium Medium natural No 15 mm Autograft Unicompartmental lateral right TKP right

Autograft 1/2 condylblock

6: F, 82 y

5Y

7: F, 72 y F2a T1 No 15 mm

6Y

F1

T2a

Medium

No

10 mm

1/2 femur head 1/2 femur head

1/2 femur head 1/2 femur head

8: F, 78 y

612 Y

Unicompartmental medial left TKP left

Medium posterior stabilized Medium under Extra small

3Y

F2b

Extra small with wedge lateral side Stayed in situ No 25 mm

1 femur head

No

9: F, 70 y F2a T2a Small No

612 Y

Femur component insert Kinemax Unicompartmental medial right 15 mm

Small posterior stabilized Small

Auto- and allograft (1/2 femur head)

Auto and allograft (1/2 femur head)

Revision Knee Arthroplasty with Impaction

Note: The amount of bone loss has been classied according to the Anderson Orthopaedic Research Institute (AORI). Y years; M months.

429

430 Table 2

Heyligers et al. Anderson Orthopaedic Research Institute Bone Defect Classicationa

Type 1 Defect: Intact metaphyseal bone Minor bone defects of distal femur (F1) or proximal tibia (T1) that do not compromise the stablility of the component. On preoperative radiographs: No component subsidence or osteolysis Femur: normal joint line with full condylar prole Tibia: component above the bular head and a full metaphyseal segment Type 2 Defect: Damaged metaphyseal bone Loss of cancellous bone in the methaphyseal segment that necessitates restoration. Type 2 defects can occur in one femoral condyle (F2A) or tibial plateau (T2A), or in both condyles (F2B) or plateaus (T2B). On preoperative radiographs: Femur: joint line elevation and a reduced condylar prole Tibia: component is at or below the tip of the bular head and the tibial are is reduced Type 3 Defect: Decient metaphyseal segment Bone loss that compromises a major portion of either femoral condyle (F3) or tibial plateau (T3). On preoperative radiographs: A decient metaphyseal segment of the femur or tibia
a

The bone defect classication is applied separately to the femur (F) and the tibia (T).

implanted in one case alone. When unicompartmental prostheses were removed, autograft was mixed with allograft in almost all cases. In most cases no autograft bone was available and only allograft bank bone could be used. All bone was cut in chips and rmly impacted layer by layer with the specially developed instruments described above. Gentamicin PMMA bone cement (Simplex, Stryker-Howmedica-Osteonics, Limerick, Ireland) was used in all cases.

III.

RESULTS

All defects of tibia and femur were type 2 except one type 1 and one type 3. Autograft bone alone was used in two knees, a combination of autograft and allograft in three, and allograft alone in six. The total amount of allograft used consisted of eight femoral heads and one condyle. The postoperative treatment, mobility, and clinical follow-up data are presented in Table 3. Five cases were immobilized in a cast for between 6 and 12 weeks. The period of immobilization depended on the extent of bone loss and stability of the joint at surgery. These factors also determined the amount of weight bearing allowed. Weight bearing after surgery was not restricted in four cases, partial for up to 6 weeks in two, and delayed for 3 months in ve. All knees were fully weight bearing 3 months postoperatively. Follow-up ranged from 212 to 612 years with a mean of 4 years

Revision Knee Arthroplasty with Impaction Table 3 Clinical Data Cast 3M No No 6W No No 6W No 6W 6W No Full loading 3M Direct 3M Direct Direct Direct 3M 6W 6W 3M 3M Mobility 90/0/0 70/0/0 90/0/0 100/0/5 120/0/10 120/0/20 120/0/5 90/0/0 90/0/0 130/0/5 120/0/5 Follow-up (yr) 212 3 312 312 412 412 5 6 3 612 612

431

Patient no., sex, age 1 F, 73 y 2 M, 62 y 3 M, 87 y 4 F, 78 y 5 left right 6 F, 77 y 7 F, 82 y 8 F, 72 y 9 F, 78 y 10 left right 11 F, 70 y

Y years; M months; mobility is in degrees exion/0/extension.

and 3 months. One femoral component loosened within 212 years of surgery. This patient (Table 1, patient No. 1) had undergone two previous revision procedures in the same knee for infection. In this case metal mesh and massive bone grafts were used to reconstruct a type 3 femoral segmental defect. The clinical presentation and technetium and labeled leukocyte scans suggested recurrent septic loosening 212 years after this procedure, although intraoperative specimens were sterile. Biopsies of the femur showed no incorporation of donor bone. During this re-revision, the tibial component was also revised. It was well xed and histology of samples from the graft site showed incorporation by predominantly new woven bone. These biopsies gave the same appearances of new bone formation as in revision hip arthroplasties after impaction grafting. Clinical and radiographic examination indicated that all other implants were well xed. There was no radiographic evidence of graft resorption, radiolucent lines, or subsidence (Figs. 4, 5). At follow-up examination, all knees were fully weight bearing. One patient (Table 1, patient No. 2) was revised for septic loosening of a cemented total knee, including the patellar component, 6 months after surgery. With a two-stage procedure including osteotomy of the tibial tuberosity, revision surgery was nally carried out with a posterior stabilized implant and patellar button. One patient with Type 2b defects of femur and tibia were treated with impaction grafting of half a femoral head on each side and postoperatively walked fully weight bearing without a cast. After 9 months there was 1008 of exion and full extension, but there were clinical signs of infection again. Cultures were negative and the patient was treated conservatively

432

Heyligers et al.

Figure 4 (A) Radiograph before revision of an infected total knee implant. (B) A two-stage procedure was performed with the use of gentamicin loaded PMMA beats. Reimplantation with impacted cancellous grafting of the knee with the use of primary implants was performed. (C) Radiograph 4 years after the operation. (From Ref. [4].)

Revision Knee Arthroplasty with Impaction

433

Figure 4 Continued.

with intravenous and oral antibiotics to which the organisms isolated before were sensitive. After this, there was clinical improvement and the inammatory markers returned to normal. There were no clinical or radiographic signs of loosening or infection. However, after this exion decreased to 708, although extension remained full and nearly 3 years later the patient is walking well without a stick.

IV.

DISCUSSION

Because we had had good results from impaction grafting bone defects in cemented hip revisions, we used the same technique in revision knee arthroplasty. Special instruments were designed to impact the graft layer by layer, allowing us to cement primary knee prostheses onto this donor bone bed. In revision hip surgery, this technique provides good prosthetic xation and new bone forms in the graft [1 3]. Lost bone is replaced by new and prostheses used in primary arthroplasty can be implanted. Impacted, morselized bone grafts have described in cementless [8,9] and cemented [10 12] revision knee arthroplasty with long stems. In revision knee arthroplasty, the treatment of bone loss with allograft has been described [13]. In primary total knee arthroplasty impacted cancellous

434

Heyligers et al.

Figure 5 Radiograph of a cemented medial unicompartimental prosthesis: (A) before revision; (B) 412 years after revision surgery with use of impaction grafting and a primary total knee implant. (C) Especially at the proximal medial tibia, trabecular bone can be seen in the area where cement was before.

Revision Knee Arthroplasty with Impaction

435

Figure 5 Continued.

autograft bone has been used [14] with a cemented tibial base plate and a long press-t modular stem. The bone quality in primary cases is, however, better than revisions, in which it is often thin and sclerotic. Autograft in primary knee replacement is more likely to be successful than allograft in revisions. Long stems were used in primary knee replacement to prevent tilting of the tibial component and promote loading of the graft in compression. With this technique, the stem itself is usually not cemented [15]. We chose not to use long stems, but to cement primary prostheses directly onto the donor bone to enhance load transfer onto the graft. This is similar to the technique in hip revision where the femoral stem is entirely surrounded by cement and transfers load onto the bone graft. We think that diaphyseal xation is unnecessary because wellimpacted bone will prevent tilting of the component and long stems may decrease load transfer onto the bone graft. With our technique, primary stability may more difcult to achieve. We think that inadequate primary stability was responsible in our failed femoral component. Segmental femoral defects treated with two pieces of femoral head and graft impacted onto metal mesh were unstable after 212 years. With large bone defects, longer stems may afford better primary xation.

436

Heyligers et al.

The theory of our technique is that primary stability is created on rmly impacted bone, which is loaded and eventually incorporates. This has been demonstrated in hip arthroplasty in a number of reports of new bone formation in graft biopsies [16 18]. This can be seen as trabeculation and cortical repair radiographically. At present we have limited experience of impaction grafting in revision knee arthroplasty, but trabeculation is seen on radiographs. The new bone formation seen in the biopsies from the xed tibial component in our revision case suggests that the same process described after hip revisions happens in impaction grafting in the knee. Stiffness 9 months after revision for infection is unlikely to be related to impaction grafting. Based on the Knee Society Roentgenographic Evaluation and Scoring System [19], there were no signs of loosening in our patients except the one femoral component described above [20] and no clinical or radiographic signs of failure as described by Lonner et al. [21]. The instruments developed make it possible to standardize the technique of impaction grafting with cemented primary prostheses. The length of follow-up in this group, however, is short and the numbers small, and it is difcult to draw denitive conclusions. However, based on our encouraging experience, we feel that the technique is suitable for cavitary defects in revision knee arthroplasties. We plan to extend our indications gradually and to adapt the technique to segmental defects. We believe that it is possible with our standardized technique of impaction grafting to use cemented primary implants without long stems in cases with bone loss and convert a revision situation to one more like a primary. This creates bone stock for the future. This technique is relatively new. Greater numbers with longer follow-up are needed to draw more denitive conclusions as to its indications. It is important that the surgeon understands the principles of impaction grafting and has experience with the technique.

REFERENCES
1. Gie GA, Linder L, Ling RS, Simon JP, Slooff TJ, Timperley AJ. Impacted cancellous allografts and cement for revision total hip arthroplasty. J Bone Joint Surg Br 1993; 75:14 21. Buma P, Lamerigts N, Schreurs BW, Gardeniers J, Versleyen D, Slooff TJ. Impacted graft incorporation after cemented acetabular revision. Histological evaluation in 8 patients. Acta Orthop Scand 1996; 67:536 540. Slooff TJ, Buma P, Schreurs BW, Schimmel JW, Huiskes R, Gardeniers J. Acetabular and femoral reconstruction with impacted graft and cement. Clin Orthop 1996; 324:108 115. Heyligers IC, van Haaren EH, Wuisman PI. Revision knee arthroplasty using impaction grafting and primary implants. J Arthroplasty 2001; 16:533 537. Standards for Tissue Banking [editorial]. American Association of Tissue Banks, 1996.

2.

3.

4. 5.

Revision Knee Arthroplasty with Impaction 6. 7. 8. 9. 10. 11.

437

12. 13.

14. 15.

16.

17.

18.

19. 20. 21.

Common Standards for Musculoskeletal Tissue Banking [editorial]. European Association for Musculo Skeletal Transplantation, 1997. Engh GA. Bone defect classication. In: Engh GA, Rorabeck CH, eds. Revision Total Knee Arthroplasty. Baltimore: Williams and Wilkins, 1997:63 121. Whiteside LA. Cementless reconstruction of massive tibial bone loss in revision total knee arthroplasty. Clin Orthop 1989; 248:80 86. Whiteside LA. Cementless revision total knee arthroplasty. Clin Orthop 1993; 286:160 167. Bradley GW. Revision total knee arthroplasty by impaction bone grafting. Clin Orthop 2000; 371:113 118. Ullmark G, Hovelius L. Impacted morsellized allograft and cement for revision total knee arthroplasty: a preliminary report of 3 cases. Acta Orthop Scand 1996; 67:10 12. Whiteside LA, Bicalho PS. Radiologic and histologic analysis of morselized allograft in revision total knee replacement. Clin Orthop 1998; 357:149 156. de Waal M, van Kampen A, Slooff TJ. Bone grafting in cemented knee replacement. 45 primary and secondary cases followed for 2 5 years. Acta Orthop Scand 1995; 66:325 328. Ries MD. Impacted cancellous autograft for contained bone defects in total knee arthroplasty. Am J Knee Surg 1996; 9:51 54. Bertin KC, Freeman MA, Samuelson KM, Ratcliffe SS, Todd RC. Stemmed revision arthroplasty for aseptic loosening of total knee replacement. J Bone Joint Surg (Br) 1985; 67:242 248. van Biezen FC, ten Have BL, Verhaar JA. Impaction bone-grafting of severely defective femora in revision total hip surgery: 21 hips followed for 41 85 months. Acta Orthop Scand 2000; 71:135 142. Schreurs BW, van Tienen TG, Buma P, Verdonschot N, Gardeniers JW, Slooff TJ. Favorable results of acetabular reconstruction with impacted morsellized bone grafts in patients younger than 50 years: a 10- to 18-year follow-up study of 34 cemented total hip arthroplasties. Acta Orthop Scand 2001; 72:120 126. van der Donk S, Buma P, Slooff TJ, Gardeniers JW, Schreurs BW. Incorporation of morselized bone grafts: a study of 24 acetabular biopsy specimens. Clin Orthop 2002; 396:131 141. Ewald FC. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system. Clin Orthop 1989; 248:9 12. Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop 1989; 248:13 14. Lonner JH, Siliski JM, Scott RD. Prodromes of failure in total knee arthroplasty. J Arthroplasty 1999; 14:488 492.

30
Different Types of Biomechanical Tests on Morselized Grafts
Xavier Banse
Universite Catholique de Louvain Brussels, Belgium

Many biomechanical tests are presented in the rst half of the book. At completion of the book, it appeared that a short note describing the various tests would be useful. Its aim is to present in a single gure the different types of mechanical testing. Each type of test is presented with a proposed name. Under each test the chapters in which the test appears in the book are listed.

I.

CONTAINED COMPRESSION TEST

This is a simple compression. Grafts are placed in a container, impacted and compressed. Verdonshot et al. (Chapter 5), Bavadekar and Cornu et al. (Chapters 8, 9, and 13), and Kobayashi et al. (Chapter 14) report using this type of test. Different impaction procedures are performed to obtain the pallets (cyclic compaction or real hammer impaction) and different types of grafts are tested (human femoral head bone or bone from the sternum of goat). The main resulting parameter is the compressive modulus (or stiffness, MPa).

II.

BIAXIAL SHEAR TEST

Such test is presented by Dunlop et al. (Chapters 6 and 11) and Kobayashi et al. (Chapter 14). Similar procedure had been proposed by Brewster et al. [1]. The principle of the test (derived from the soil mechanics) is to gently compress a
439

440

Banse

Figure 1

Biomechanical tests at a glance.

Different Types of Biomechanical Tests on Morselized Grafts

441

volume of material while shifting the two halves of the container. This produces a shear failure within the material. A shear modulus and a shear strength (MPa) are obtained. Note that shear properties are always recorded while compressing the grafts.

III.

TRIAXIAL SHEAR TEST

This test is only mentioned in Chapter 6 [2]. Grafts are placed in a cylinder with a soft membrane around it. The upper plate moves toward the lower plate. Lateral containment is obtained by pressurizing the liquid around the membrane.

IV.

AXIAL COMPRESSION ON CUP

An acetabular reconstruction is performed either on a human hemipelvis or on a plastic model (Verdonschot et al., Chapter 5). A defect is lled with grafts, grafts are impacted, and a cup is cemented in the impacted grafts. The test is performed applying an axial load on the cup. The resulting stress on the graft layer is essentially compression which is applied repeatedly (i.e., 3000 cycles). The implant migration is measured.

V.

SHEAR ON CUP

This test is also called the lever out test by Verdonschot et al. in Chapter 5. A handle is xed to the cup. Applying a lateral movement to this joystick will cause the cup to slip within the layer of grafts, creating a pure shear failure. The force needed to rotate the cup is recorded. A similar test is reported by Ullmark [3].

VI.

AXIAL COMPRESSION ON STEM

This type of test is presented by Verdonschot et al. (Chapter 5) and Dunlop et al. (Chapter 11) using goat femurs. Kuiper et al. (Chapter 7) and Kobayashi et al. (Chapter 14) used plastic models of femur (Glass-epoxy or Sawbonew). A femoral defect is created, and reconstruction is simulated with impacted grafts. Many parameters can have been tested: type of stem, cementation, type of grafting material, type of impaction, etc. Usually, between 100 and 1000 cyclic loading are performed. Load is applied on the head of the prosthesis, and the displacement of the stem (or its varus rotation) is measured.

442

Banse

As grafts are contained between the femur and the implant, axial displacement of the stem will create a combination of compression and shear within the graft layer. To imagine how it works, take the two rst gures (contained compression and biaxial shear), turn them 908 and you will have a better idea of what happens within the graft mantle when the stem is loaded.

VII.

TORSION ON STEM

Using the same set-up as described above, the stem can be rotated (Kobayashi et al., Chapter 14). Shear failure happens within the graft mantle.

VIII.

WALKING SIMULATION

Godts et al. (Chapter 12) use pairs of human femurs, create a signicant defect, and perform reconstruction with impacted bone grafts. The stem is then axially loaded during 10 days (about one million cycles). Axial subsidence and micromotion of the implant can be measured. Although not presented in the gure, Kuiper et al. (Chapter 7) also present a model of knee revision using plastic tibial models. Their test is similar to axial compression on stem, even if the load was selectively applied on the medial or lateral side of the implant.

REFERENCES
1. Brewster NT, Gillespie WJ, Howie CR, Madabhushi SP, Usmani AS, Fairbairn DR. Mechanical consideration in impaction bone grafting. J Bone Joint Surg 1999; 81B:118 124. Brodt MD, Swan CC, Brown TD. Mechanical behavior of human morselized cancellous bone in triaxial compression testing. J Orthop Res 1998; 16:43 49. Ullmark G. Bigger size and defatting of bone chips will increase cup stability. Arch Orthop Trauma Surg 2000; 120:445 447.

2. 3.

INDEX

Acetabular bone defect (clinical): AAOS classication, 277 280, 308 classication systems, 276 ethiology, 275 Acetabular reconstruction (clinical): adding ceramics, 132 aim of the technique, 278, 288 alternative to impaction grafting, 275, 307, 377 complications, 312 for congenital hip displasia, 280 281, 291 impactor, 227, 284 mesh, 228, 282 284, 289, 293 patients installation, 281 pelvic discontinuity, 279, 308 post-operative care, 284, 289, 309 preparation of the morselized grafts, 284, 288, 309 reinforcement rings, 301, 308, 314 results, 70, 227, 290 294, 312 primary THA, 290 patients under 50 y, 291 revision arthroplasty, 294, 311 314 rheumatoid arthritis, 298 reverse reaming, 48, 285 review of the published series, 229, 316

structural bone graft, 293, 301, 307 surgical approach, 281282, 309 surgical technique ring, 309 X-change, 281286 Acetabular reconstruction (experimental): animal model, 261 axial compression tests, 45 impaction technique, 45 48 shear test (lever-out), 49 American Association of Tissue Banks (AATB), 12, 403, 424 Anderson Orthopaedic Research Institute bone defect classication, 430 Animal models (in vivo): dog acetabular defect dog onlay cortical graft, 259 dog segmental defect, 259 goat bone conduction chamber, 243 ovine defect, 144 ovine femoral, 51, 131, 145 rabbit knee prosthesis, 215 rat bone conduction chamber, 208 Bacterial contamination: post-mortem blood culture, 25 rifampicine immersion, 14, 27 443

444 risk of, 15, 24, 26, 35, 122 sample culture, 13, 25 screening, 16, 24, 35, 424 swab culture, 25, 424 Biological properties of ceramics, 130 Biological properties of the morselized grafts (experimental): effect of washing, 71, 245, 249 251 effect of impaction, 91, 208 211, 249 251 enhancement with OP-1, 257 266, 270 immunogenicity, 211 ingrowth distance, 208 212, 249 251 remodeling of the grafts, 207, 214, 245, 247 response to load, 214 Biphosphonate, 271 Bone conduction chamber (BCC), 210, 243 Bone morphogenetic proteins or BMPs (see Growth factors)

Index Congenital hip dysplasia (CHD), 291 Consent for tissue retrieval: law regulations, 13 Cortical (structural) allograft (see Strut graft) Creutzfeldt-Jakob disease (see Prions) Cyclic loading in simulations, 45, 77, 148, 158 174 Density of the compacted graft, 83, 85, 88, 101, 116, 173 Disease transmission (see also Bacterial transmission or Viral transmission), 12, 24 Donor selection and screening, 12, 17, 24, 34 Donor type: deceased donors, 13, 24, 35 living donors, 13, 15, 23, 34, 36 organ donors, 13, 15, 24 Ethylene oxide, 17, 27 European Association of Musculoskeletal Transplantation (EAMST), 12, 24, 424 European Association of Tissue Banks (EATB), 12, 24 Femoral reconstruction (clinical): alternative to impaction grafting, 381 with BMP, 264, 270 cement, 342, 352, 371 cerclage wire or cables, 331, 351, 354, 371, 384 complications, 346, 354, 358, 365, 372 373, 388 extended trochanteric osteotomy, 328, 365, 384, 388 with freeze-dried grafts, 349, 385 impactors (packers, phantoms), 332 341, 351, 371, 386 meshes, 324, 321, 338 339, 351, 365 patients installation, 324, 326 post-operative care, 346, 354, 372

Cartilage inclusions: in biopsies, 248, 252 effect on mechanical behavior, 100 in femoral impaction, 329 Cement: in acetabular reconstruction, 284, 302 creep, 172, 358, 391 in femoral reconstruction, 342 mantle fracture, 354, 373, 391 mantle thickness, 172, 382, 386 penetration in graft mantle, 92 removal during revision, 309, 328, 351, 367, 385 Ceramics (absorbable), 126 biological properties, 130, 145 manufacture, 126 mechanical properties, 127, 142 143 mechanical strength, 127 128 mixed with allograft, 128, 130 133, 143 151 resorption and dissolution, 129 Compaction curve, 85, 87, 114 Compaction protocol, 43, 64, 97, 112, 190, 243

Index pre-operative planning, 324, 350, 365, 384 preparation of the morselized grafts, 329, 351, 371, 386 results, 207, 227, 346, 352, 372, 394 review of the published series, 230, 392 393 stem type, 325, 365, 380 381 strut graft, 346, 351, 354, 371, 384 subsidence, 75, 346, 359, 372 surgical approach, 325, 384 surgical technique enmeshed, 367 X-change, 324, 331, 350 torque wrench, 388 Femoral reconstruction (experimental): assessing degree of compaction, 80 82 cavitary defect, 160, 195 cement mantle, 41 hip simulator, 148, 158 174 impaction procedure, 163, 195 impaction set, 80 82, 86 implant positioning/reproducibility, 159 inuence of compaction, 80, 84 inuence of stem design, 77 79 initial stability, 41, 79, 90, 164 166, 197 in vivo model, 51, 145 mesh (metal) in, 51 53 micromotion, 146 150, 164 174, 196 push out test, 168 rotation of the implant, 163, 197 segmental defect, 51 strut grafts in, 51 53 subsidence, 41, 51, 75 82, 146, 164 174, 197 Follow-up study: quality, 289 Fracture of the host bone, 90, 279 femur 90, 331, 346, 365, 388 pelvic discontinuity, 279, 285 Freeze-dried bone particles, 16, 349 implant stability and, 173 protocol, 111, 350 reconstitution or rehydration, 19, 112, 161, 351 remodeling (clinical), 355 357

445 sample weight loss, 110, 162 under hip simulator, 161 Frequency or revision arthroplasty, 11, 141 Fuller curve (particle size), 59 60 Growth factors (see Osteogenic factors) Harris hip score (HSS), 290298, 309, 312, 354 Heat treatment, 28 Hepatitis B, 12, 15, 24 Hepatitis C, 12, 14 17, 24, 121 Histology of impacted grafts: clinical cases, 218, 233 237, 245 249, 251, 431 experimental, 129, 209, 213, 216 History (of impaction bone grafting): hip revision, 1 9, 205 208, 289, 380 knee revision, 400 HIV, 12, 14 17, 24, 26, 121, 424 Hydroxyapatite (see Ceramics) Impaction bone grafting (see Acetabulum, Femur, or Knee) Indications: for hip revision, 287, 323, 372 for knee revision, 400 Infection: exclusion before revision, 275, 282, 285, 288, 323, 327, 424 in impaction bone grafting, 24 in massive allografts, 24 treatment with impaction bone, 401 Instrumentation (for clinical use): acetabular impactor, 227, 284 Schneider-Burch ring, 309 Irradiation, 17, 27, 315 bacteria and, 17, 27 effect on biological properties, 27 effect on mechanical properties, 17, 27, 110 low dose, 27 prions and, 17 virus and, 17, 27

446 Knee arthroplasty revision (clinical): aim of the technique, 401 alternative to impaction grafting, 399 400 cement, 418, 425, 435 complications, 412, 431, 436 exion balance, 402 impactor, 403, 417, 425 indications, 400 joint line postion, 401 402, 425 mesh, 404, 418, 424 post-operative care, 408, 426, 430 preparation of morselized grafts, 403, 417, 424 results, 409, 420, 430 surgical approach, 403, 427 surgical technique (LCS), 401 409 subsidence, 413, 420, 431 surgical technique Kinemax, 424 426 Link, 417 Knee arthroplasty revision (experimental): inuence of compaction, 83 in vivo rabbit model, 215 graft mantle densitometry, 83 84 proximal tibial model, 82 Knee Society score, 412

Index particle grading, 67 particle size (see Particle size) recoil, 43 shear test, 64, 143, 192195 viscoelastic behavior, 43 washing, 47 51, 67, 70, 117 Mechanical stimulation and remodeling, 214 219 Merle dAubigne hip score, 372 Mesh (use of metal): in acetabular defect, 227, 282 284 as metal back of acetabular implant, 289 in segmental femur defect, 51 53 Micromotion (see Femoral side) Mohr-Coulomb failure law (shear test), 61, 67, 194

Mechanical properites of absorbable ceramics, 127, 142 143 Mechanical properties of the allograft: effect of freeze-drying, 16 effect of irradiation, 17 Mechanical properties of the morselized particles: in acetabular reconstructions, 45, 49 compaction protocol (see Compaction protocol) compression tests, 42, 85, 88, 97 99, 111 113, 184 during impaction blow, 86, 117, 189 effect of cartilage inclusions, 101 effect of compaction, 72, 85, 87, 100 104, 173 in femoral reconstruction, 167, 173

Order schedule of allograft, 38 Osseointegration (or osteointegration): of ceramics, 130 and microporosity, 130 Osteoarthritic femoral head, 36 37, 160, 188 density, 38 Osteogenic factors, 257 266, 269 272 BMPs, 213, 219, 259, 270 endogenous release, 212 exogenous addition, 213, 214, 219 OP-1, 214, 219, 258 256, 272 TGF-b, 242 Osteoinductive capacity, 15 Osteoporotic femoral head, 36, 88, 188

Particle shape, 70, 182 Particle size, 45 50, 117 185, 201, 329 in acetabular test, 45 51 in compression test, 103, 184 distribution, 60, 192, 347 grading (theory), 58 62 in vivo defect model, 145 measurement, 63, 180, 188 rongeur or bone mill, 45, 68, 179, 188, 242, 285, 288, 309 in shear test, 64, 68, 192 195

Index Polymerase chain reaction (PCR), 12, 14, 24, 35 Positron emission tomography (PET) and healing of the graft bed, 231, 318 Preparation of the morselized grafts for acetabular reconstruction (clinical), 284, 288, 309 for acetabular side test, 45 50 in the bone bank, 18 cartilage removal, 97, 105 for compression test, 96, 110 cortical bone removal, 97, 105 for femoral reconstruction (clinical), 329, 350, 371, 394 freeze-drying and irradiation, 111 loss of material, 100, 102, 105, 114, 182 for shear test, 62 63, 188 washing, 47 51, 67, 70, 117 Preservation (of the allograft), 16, 28 deep-freezing, 16, 28 freeze-drying, 16, 28, 350 packaging, 18 19 reconstitution, 18 19 Prions: donor selection, 12 graft chemical treatment, 16 graft irradiation, 17 xenograft and, 123, 126 Processing (of the allograft), 15, 25 chemical treatment, 16, 27 shaping and cutting, 15, 26 supercritical CO2, 16, 28 water jet lavage, 16, 26 Quarantine, 15, 35, 117 Recombinant human proteins (see Osteogenic factors) Record keeping, 18 Remodeling of the impacted bone grafts (clinical) histology, 233 237, 245 249, 431 radiological, 292, 299, 312, 354 356, 372, 436 studied by PET scan, 231, 318

447 studied by SPECT, 355 Rhesus factor, 13, 329 Rheumatoid arthritis, 298 Ring (use of metal), 227 Rinsing the grafts (see Washing grafts) Roentgen stereophotogrammic analysis (RSA), 146

Sieving particles, 63 Soil engineering, 57, 80 Sterilization, 17, 26 Strut (cortical) graft: clinical practice, 258, 354, 384 clinical use with OP-1, 265 266 onlay animal model, 259 segmental defect animal model, 51 53, 259 Subsidence: along with time, 394 of femoral stem, 41, 51, 75, 346, 354, 372, 391 inuence of stem design, 77 79 in knee revision, 413 in soil mechanics, 58 Substitute (to bone allograft), 121, 141 absorbable ceramics (see Ceramics), 126 classication, 123 commercially available products (list), 124 corraline hydroxyapatite, 126, 142 xenograft, 122 Supply of bone allografts: amount of bone per procedure, 33, 37, 109, 167, 242, 350, 354, 403 bone bank regulation, 34, 403 cost of the allograft, 34, 36, 122 demand (shortfall) and, 33, 109, 121, 350 issue by weight, 37 leaving cortical bone, 106 number of grafting procedures, 33 Surgical technique (see the corresponding anatomical site) Symmetrical (left-right) models, 173

448 Transmissible spongiform encephalopathy or TSE (see Prions) Tricalcium Phosphate or TCP (see Ceramics) Tumor transmission (by graft), 35 Viral contamination: risk of, 14 15, 24, 109, 358 seronegative window, 14

Index

Washing the grafts, 47 51, 67, 70, 117, 188, 243, 249 251 Washing technique, 63 Weight used to order allografts, 38