This is an enhanced PDF from The Journal of Bone and Joint Surgery

The PDF of the article you requested follows this cover page.

Clinical Performance of Highly Cross-Linked Polyethylenes in Total

Hip Arthroplasty
Cale A. Jacobs, Christian P. Christensen, A. Seth Greenwald and Harry McKellop
J Bone Joint Surg Am. 2007;89:2779-2786. doi:10.2106/JBJS.G.00043

This information is current as of January 7, 2008

Supplementary material

Commentary and Perspective, data tables, additional images, video clips and/or
translated abstracts are available for this article. This information can be
accessed at http://www.ejbjs.org/cgi/content/full/89/12/2779/DC1

Reprints and Permissions

Click here to order reprints or request permission to use material from this
article, or locate the article citation on jbjs.org and click on the [Reprints and
Permissions] link.

Publisher Information

The Journal of Bone and Joint Surgery

20 Pickering Street, Needham, MA 02492-3157
www.jbjs.org

2779
C OPYRIGHT 2007 BY T HE J OURNAL

OF

B ONE

AND J OINT

S URGERY , I NCORPORATED

Current Concepts Review

Clinical Performance of Highly Cross-Linked

Polyethylenes in Total Hip Arthroplasty
By Cale A. Jacobs, PhD, Christian P. Christensen, MD, A. Seth Greenwald, DPhil(Oxon), and Harry McKellop, PhD

Aseptic loosening secondary to wear-debris-induced osteolysis has been identified as the leading cause of
late failure of total hip arthroplasty.

Highly cross-linked polyethylene acetabular liners were developed as one approach to reducing this wear.

Preclinical laboratory wear testing showed a number of cross-linked polyethylenes to have dramatically less
wear than the polyethylene that had been in use for several decades.

After the initial bedding-in phase (one to two years), the percent reductions in the wear rate, as indicated by
the amount of penetration of the head into the socket evident on serial radiographs, have been comparable
with what was predicted from preclinical hip-simulator testing of the highly cross-linked polyethylenes.

To our knowledge, there have been no reports of clinically relevant osteolysis that was clearly attributable
to wear of a highly cross-linked polyethylene acetabular liner. However, the clinical performance of these
materials should be closely monitored with long-term follow-up.

Total hip arthroplasty with use of traditional metal-onpolyethylene bearing couples has been demonstrated to be
an effective treatment to improve function and reduce pain
in patients with severe osteoarthritis, rheumatoid arthritis,
osteonecrosis, and other conditions affecting the hip1. Despite
this overall clinical success, the clinical life span of total hip
prostheses often has been limited by osteolysis and, in some
cases, aseptic loosening brought on by the macrophage response to wear particles2. Osteolysis secondary to polyethylene
wear has been described as one of the primary reasons for late
revision of total hip arthroplasties3,4. It follows that improving
the wear resistance of the polyethylene could contribute to
greater durability of hip prostheses.
As a result of the aging of the baby boomer population,
the number of primary total hip arthroplasties performed
annually in the United States has been projected to increase
during the next fifteen years from 208,000 to more than

384,0005. Not surprisingly, the number of revision procedures

also is projected to increase, from 36,000 to an estimated 67,000
annually by the year 20205. Furthermore, during the past
decade, the indications for total hip arthroplasty have been
expanded to include progressively younger patients. The
increased activity level of these patients, combined with their
increased life expectancy, has in turn amplified the need for
greater implant durability.
Since wear-related osteolysis was first identified as a
cause of revision, other bearing couples have been developed in
an attempt to decrease particle generation. In the 1990s, a
number of highly cross-linked polyethylenes were developed as
one approach to reducing wear of total hip prostheses and,
potentially, to increasing implant longevity. Laboratory wear
testing of the highly cross-linked polyethylenes in hip joint
simulators demonstrated dramatically improved wear resistance, with many investigators reporting reductions in wear of

Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. One or more of
the authors, or a member of his or her immediate family, received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide such benefits from commercial entities (DePuy Orthopaedics and Biomet Orthopedics). Commercial entities
(DePuy Orthopaedics, Biomet Orthopedics, and Smith and Nephew) paid or directed in any one year, or agreed to pay or direct, benefits in excess of
$10,000 to a research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which one or more of
the authors, or a member of his or her immediate family, is affiliated or associated.

J Bone Joint Surg Am. 2007;89:2779-86

doi:10.2106/JBJS.G.00043

2780
THE JOURNAL OF BONE & JOINT SURGERY JBJS.ORG
V O L U M E 89-A N U M B E R 12 D E C E M B E R 2 007

C L I N I C A L P E R F O R M A N C E O F H I G H L Y C R O S S -L I N K E D
POLYETHYLENES IN TOTAL HIP ARTHROPLASTY

>90% even under adverse conditions, such as with largediameter femoral heads, with roughened femoral heads, and in
the presence of third-body particles6-11. This review documents
the midterm clinical performance, and summarizes factors potentially affecting the future performance, of total hip prostheses with highly cross-linked polyethylene bearings.
Clinical Importance of Reduced Polyethylene Wear
Reducing polyethylene wear could have a tremendous effect on
the clinical success of total hip arthroplasty. Excessive polyethylene wear can lead to late failures as a result of several
different mechanisms. The most common failure mechanisms
that have been associated with polyethylene wear are osteolysis
and aseptic loosening3,4, and Parvizi et al.12 recently reported
that excessive wear contributed to the prevalence of late dislocations. Similarly, Clohisy et al.3 reported that aseptic loosening, dislocation, and osteolysis were the primary reasons for
revision in 82% of their cases. With this in mind, it is easy to
appreciate the clinical importance of improved polyethylene
wear characteristics.
Revision arthroplasty has not had the same level of
clinical success as primary hip arthroplasty. Many factors
contribute to the poorer outcomes following revision arthroplasty; these include increased age, infection, inadequate
bone stock, and an increased number of comorbidities. The
decreased wear rates associated with highly cross-linked polyethylene liners may improve the longevity of primary total
hip prostheses by reducing the prevalence of late osteolysis
and the resultant bone loss and implant loosening. This could
help to reduce the need for revision hip arthroplasty.
Manufacturing Processes
The specific processes used to manufacture the highly crosslinked polyethylenes directly affect the amount of cross-linking
and, therefore, the material characteristics of these bearings.
Three of the most influential factors are the dose of irradiation,
the type of post-irradiation thermal processing, and the type of
end-point sterilization. So-called first-generation highly crosslinked polyethylenes have been categorized into four types
on the basis of these manufacturing processes: cold-irradiated
and annealed, cold-irradiated and subsequently melted, warmirradiated and adiabatic melted, and warm-irradiated and
subsequently melted (Fig. 1)13,14.
In the process of creating highly cross-linked polyethylene, ultra-high molecular weight polyethylene is irradiated in order to break the carbon-hydrogen chains within the
polymer, and free radicals are created. In an oxygen-rich environment, free radicals facilitate oxidative degradation of
the polymer; however, free radicals can also combine with
adjacent molecules to form cross-links. As the dose of irradiation increases, so does the density of the cross-linking
and, therefore, the resistance to wear15. However, despite increased resistance to wear, excessive cross-linking might not
lead to a better overall clinical performance because, as the
amount of cross-linking increases, there is a corresponding
decrease in some mechanical properties, including ultimate

tensile strength and resistance to fatigue crack propagation16.

Preclinical testing suggested that the optimum irradiation
dose to maximize wear resistance while maintaining tensile
strength and resistance to fatigue crack propagation is from 5
to 10 Mrad (50 to 100 kGy)10,17,18.
It is not clear whether the amount of cross-linking
markedly affects the risk of accelerated polyethylene wear due
to impingement of the femoral neck on the rim of the liner.
For example, Holley et al.18 used a hip simulator to compare
the wear behaviors of polyethylene liners that had been crosslinked with 2.8, 10, or 20 Mrad (28, 100, or 200 kGy) of
gamma irradiation, with the added condition of neck-liner
impingement. The cups irradiated with 10 Mrad demonstrated the lowest wear rates; however, as the test progressed,
those cups apparently generated more small wear particles
(approximately 0.2 mm) than did the cups irradiated with 2.8
Mrad. This could be a cause for concern since it has been
suggested that particles in the size range of 0.1 to 0.5 mm are
more biologically active than larger particles19,20.
As mentioned previously, the radiation that is used to
generate the cross-linking, whether gamma or electron-beam
(e-beam), also generates uncombined free radicals. If these
free radicals are allowed to remain in the polyethylene, and if
oxygen diffuses into the polyethylene during shelf storage
and/or clinical use of the implant, they can predispose the material to severe oxidative degradation. With the highly crosslinked polyethylenes that were introduced in the late 1990s,
the concentration of these free radicals was reduced with use
of either post-irradiation melting or annealing. Melting of
polyethylene means heating it above the melt point (>135C),
so that the polyethylene changes from a partially crystalline
state to a completely amorphous solid. Melting allows access
to free radicals in the crystalline regions by unfolding the
polymer chains. The cross-links that are formed act as
molecular constraints during cooling, so that the final crystallinity is lower and the crystals are smaller than before crosslinking and melting. This decrease in crystallinity, in turn,
leads to an additional reduction in certain mechanical properties, such as crack resistance and fracture toughness16,21,22.
In contrast, annealing refers to heating the polyethylene
to a temperature somewhat below the melting point. This
avoids the reduction in crystallinity that occurs with melting.
However, annealing is much less effective than melting in
extinguishing the free radicals, and those that remain in the
polyethylene can lead to long-term oxidative degradation of
its mechanical properties15. As will be discussed, it is this inherent dissimilarity between melting and annealing that has
led to the development of newer, so-called second-generation methods for removing the free radicals from the highly
cross-linked polyethylene in an effort to avoid reducing the
crystallinity.
The type of sterilization has been reported to directly
affect the shelf life and wear characteristics of traditional
polyethylene23-25. Polyethylene components that were sterilized with gamma radiation in air contained free radicals and
therefore were susceptible to oxidation during shelf storage

2781
THE JOURNAL OF BONE & JOINT SURGERY JBJS.ORG
V O L U M E 89-A N U M B E R 12 D E C E M B E R 2 007

C L I N I C A L P E R F O R M A N C E O F H I G H L Y C R O S S -L I N K E D
POLYETHYLENES IN TOTAL HIP ARTHROPLASTY

Fig. 1

Methods of manufacturing first-generation moderately and highly cross-linked ultra-high molecular weight polyethylene acetabular liners with published clinical wear data. (Reproduced, with modification, from: Greenwald AS,
Bauer TW, Ries MD; Committee on Biomedical Engineering, Committee on Hip and Knee Arthritis. New polys for old:
contribution or caveat? J Bone Joint Surg Am. 2001;83 Suppl 2[Pt1]:27-31.)

and during use in vivo. Sterilization without radiationi.e.,

with use of ethylene oxide or gas plasmaavoided the generation of free radicals, but the lack of cross-linking resulted in
less resistance to wear, both during laboratory testing26 and in
clinical use24.
In part, it was this inherent trade-off between oxidation
resistance and wear resistance with the traditional polyethylenes that motivated the development of the cross-linkedremelted polyethylenes, in which the cross-linking is obtained
by exposure to radiation. The resultant free radicals are
eliminated by remelting, and the terminal sterilization is done
with ethylene oxide or gas plasma to avoid reintroducing free

radicals. The choice of gas plasma or ethylene oxide does not

appear to have a measurable effect on the wear resistance. For
example, Durasul and Longevity highly cross-linked polyethylenes (Zimmer, Warsaw, Indiana) are manufactured with use
of very similar processes, with the exception that Longevity
polyethylene is sterilized with gas plasma and Durasul polyethylene is sterilized with ethylene oxide. Despite the different
types of sterilization, these two highly cross-linked polyethylenes have demonstrated very similar wear rates both in the
laboratory and clinically27,28.
In contrast, as with traditional polyethylene, terminal
sterilization of a highly cross-linked polyethylene with gamma

2782
THE JOURNAL OF BONE & JOINT SURGERY JBJS.ORG
V O L U M E 89-A N U M B E R 12 D E C E M B E R 2 007

C L I N I C A L P E R F O R M A N C E O F H I G H L Y C R O S S -L I N K E D
POLYETHYLENES IN TOTAL HIP ARTHROPLASTY

radiation generates free radicals in the polymer that are

susceptible to oxidation. For example, in an examination of
fourteen Crossfire acetabular cups (Stryker Orthopaedics,
Mahwah, New Jersey) (which are annealed and terminally
sterilized with gamma radiation) that were retrieved after a
maximum of thirty-three months of clinical use, Wannomae
et al.29 measured levels of oxidation that were as high as those
observed in traditional gamma-sterilized-in-air cups after
fifteen to twenty years of use. In contrast, Wannomae et al.
found that the level of oxidation was negligible in twelve
Longevity cups (which are remelted and terminally sterilized
with gas plasma) after a comparable duration of use. In an
analysis of twelve retrieved Crossfire liners, Kurtz et al.30
reported that oxidation was present in the unworn regions
but not in the worn regions. Those authors suggested that the
oxidation may not be clinically meaningful, as Crossfire
acetabular liners have exhibited low wear in vivo, consistent
with their high level of cross-linking31. Longer clinical followup will be needed to determine whether the oxidation of the
non-bearing regions of Crossfire components might eventually
impact their clinical performance.
Factors Influencing Clinical Performance
Traditionally, patient factors such as age, gender, body mass
index, and activity level have been related to increased polyethylene wear; however, neither early nor midterm clinical
wear of highly cross-linked polyethylene liners appears to be
measurably influenced by these factors28,31-33. The material
properties and wear characteristics resulting from the specific
processes used to induce cross-linking are perhaps more
important than patient-related factors. Furthermore, it is
important to note that no polyethylene-related complications
were reported in four studies of midterm data (after a duration
of follow-up of more than five years)31,32,34,35. However, the
operations in these studies were all performed by highly
experienced surgeons at high-volume centers. High surgeon
and hospital volumes have been associated with a decreased
risk of revision36,37i.e., highly experienced surgeons tend to
report very low revision rates, regardless of implant selection.
Nevertheless, the potential for an increased risk of complications and/or failures of highly cross-linked polyethylene
liners as a result of improper acetabular alignment and/or
neck impingement serves as a reminder that improvements in
polyethylene wear characteristics are not a substitute for sound
surgical technique.
Proper alignment of the acetabular component is essential for a satisfactory long-term clinical performance of any type
of polyethylene. When a cup is inserted in excessive vertical
alignment, the contact zone between the ball and cup may be
near or at the upper rim (equator) of the cup. This may cause
excessively high stresses in the polyethylene, in turn leading to
rapid wear and/or fatigue fracture38. Theoretically, this problem might be exacerbated by use of some types of highly crosslinked polyethylene liners for two reasons. First, increased
cross-linking and remelting both tend to reduce the fracture
toughness of the polyethylene (relative to that of non-cross-

linked polyethylene)16,21,22. Second, because of its greater resistance to wear, highly cross-linked polyethylene has been made
available for use with larger-diameter balls, to decrease the risk
of neck-socket impingement and dislocation. As a consequence, these liners are necessarily thinner, especially at the rim
in the location of the locking mechanism, which also reduces
the resistance to fatigue cracking39.
Although large femoral heads have been associated with
increased wear of traditional ultra-high molecular weight
polyethylene acetabular liners40, this trend does not appear to
carry over to highly cross-linked polyethylene liners. In a hipsimulator study comparing polyethylene wear between nominally cross-linked polyethylene liners (irradiated with 2.9
Mrad [29 kGy]) and highly cross-linked polyethylene liners
(irradiated with 10.5 Mrad [105 kGy] and annealed), Hermida
et al. reported that the highly cross-linked polyethylene liners
demonstrated a 90% reduction in wear when they were used
with a 28-mm femoral head and an 85% reduction in wear
when they were used with a 32-mm head41. Furthermore, the
authors stated that increasing the head size did not significantly increase the wear of the highly cross-linked polyethylene
liners. Similarly, in a study with a mean duration of follow-up
of 3.3 years, Geller et al. reported that clinical wear rates
of Durasul and Longevity highly cross-linked polyethylene
liners did not differ among groups of patients with a 36, 38, or
40-mm femoral head42.
Accuracy of Wear Measurement Techniques
The amount of polyethylene wear during clinical use is typically
estimated by measuring the distance that the femoral head
penetrated into the polyethylene liner over time. Techniques for
measuring femoral head penetration on serial radiographs fall
into three categories: manual, computer-assisted, and radiostereometry analysis. Each technique has advantages and disadvantages, and there is no clear consensus in the literature
regarding which of the three is the most suitable for assessing
femoral head penetration into highly cross-linked polyethylene
liners. We are not aware of any single study in which all three
techniques have been directly compared, although manual
techniques have been compared with computer-assisted techniques43,44 and computer-assisted techniques have been compared with radiostereometry analysis45.
Some early manual and computer-assisted techniques
for measurement of femoral head penetration resulted in
relatively large errors in the estimations of polyethylene wear.
In a hip-simulator study of polyethylene wear in which they
used a phantom apparatus, Kang et al.43 evaluated the accuracy
of wear measurements with use of the manual techniques
described by Livermore et al.46 and Dorr and Wan47 and the
computerized technique described by Devane et al.48. A modified version of the technique described by Dorr and Wan
appeared to be the more accurate of the two manual techniques, with the 0.17-mm mean error with this technique being
closer to the 0.14-mm mean error of the computerized
technique described by Devane et al. than to the 0.21-mm
mean error of the manual technique described by Livermore

2783
THE JOURNAL OF BONE & JOINT SURGERY JBJS.ORG
V O L U M E 89-A N U M B E R 12 D E C E M B E R 2 007

C L I N I C A L P E R F O R M A N C E O F H I G H L Y C R O S S -L I N K E D
POLYETHYLENES IN TOTAL HIP ARTHROPLASTY

TABLE I Percent Wear Reductions in Early and Midterm Clinical Studies of Highly Cross-Linked Polyethylene Acetabular Liners
Compared with Previously Used Polyethylenes
Manufacturing Process for
Highly Cross-Linked Polyethylene
Cold-irradiated and annealed (Crossfire)

Mean Duration of
Follow-up (yr)

Study
63

Rohrl et al.

64

Martell et al.

65

Krushell et al.

31

DAntonio et al.
Cold-irradiated and melted (Marathon)

33

Heisel et al.

Sterilization Process for

Comparison Polyethylene

% Wear Reduction

Gamma-irradiated, air

2-3

Gamma-irradiated, inert

85
42

Gamma-irradiated, inert

58

4.9

Gamma-irradiated, inert

60

2.8

Gamma-irradiated, air

72

Sychterz et al.

3.2

Gas plasma

45

34

5.3
5.5

Gamma-irradiated, air
Gas plasma

73
95

Gamma-irradiated, inert

54

2.6

Gamma-irradiated, air

94

Gamma-irradiated, inert

23

3.8

Gamma-irradiated, air

83

Gamma-irradiated, inert

55

66

Bitsch et al.
35
Engh et al.

67

Warm-irradiated and adiabatic melted

Digas et al.

(Durasul)

Manning et al.

28

Digas et al.

27
68

Bragdon et al.
32

Dorr et al.

28

Warm-irradiated and subsequently melted

Manning et al.

2.6

Gamma-irradiated, air

90

(Longevity)

Hopper et al.

69

2.9

Gas plasma

44

Gamma-irradiated, inert

31

Digas et al.

27

et al. In another laboratory study, Ebramzadeh et al.44 reported

that the median error of the method described by Livermore
et al. was 0.1 mm, which was similar to the median errors of the
two computer-assisted techniques described by Devane et al.
and Martell et al.49.
The computer-assisted method described by Martell
et al.49 presently is the most commonly used technique for
assessing femoral head penetration into highly cross-linked
polyethylene liners. This method utilizes edge-detection software that first identifies the margins of the femoral head and
acetabular cup and then calculates the center of each component. Because variabilities in patient position, exposure
dose, and other factors can distort the ellipse created by the
mouth of the acetabular component, clinical radiographs can
be rejected by the edge-detection software. Consequently, the
method of Martell et al. is not purely automated, as observers
may be required either to verify the ellipse identified by the
software or to manually identify the outer rim of the
acetabular cup. Several authors have reported a relatively
high prevalence of negative wear values with use of this
technique; these may be due to a combination of the small
magnitude of wear of highly cross-linked polyethylene, inconsistent radiographic quality due to underexposure and/or
patient positioning, and human error in detecting the rim of
the acetabular component31,45,50. However, since the measurement error can be in the positive or the negative direction, it
is unclear if negative values lead to an underestimation of the
amount of polyethylene wear. For example, despite noting
that two of three observers occasionally reported negative
femoral head penetration values, Bragdon et al.45 found that
wear rates estimated with the use of the method of Martell et al.

were significantly larger (p = 0.0001) than those determined

with radiostereometry analysis.
Radiostereometry analysis is considered to be the most
accurate method for measuring femoral head penetration. This
technique demonstrates the relative change of position over
time between the femoral head and multiple radiolucent beads
embedded in the polyethylene liner. The mean accuracy has
been reported to range from 0.033 to 0.036 mm in the medial
direction and from 0.022 to 0.023 mm in the superior
direction51,52. However, use of this technique in prospective
clinical trials involving large numbers of patients can be both
time and cost prohibitive. Also, while radiostereometry analysis may be the most accurate method for detecting migration
of the head into the articulating surface of the acetabular liner,
it cannot detect backside wear45. Retrieval studies have demonstrated backside wear in 16%53 and 27%54 of modular liners
made of traditional ultra-high molecular weight polyethylene,
and the resultant polyethylene debris could contribute to
osteolysis. We are not aware of any published studies addressing the amount of backside wear occurring in acetabular cups
made of highly cross-linked polyethylene.
Early and Midterm Clinical Results
Although the apparent wear rate of the highly cross-linked
polyethylenes during the first few years of clinical use has been
lower than that of traditional polyethylenes, the amount of
reduction has been smaller than the percent reductions measured with prior hip-simulator wear testing. As shown in Table
I, the percent reductions in the rate of femoral head penetration
have ranged from 23%27 to 95%35, depending on which
traditional polyethylene was used as a control. This difference

2784
THE JOURNAL OF BONE & JOINT SURGERY JBJS.ORG
V O L U M E 89-A N U M B E R 12 D E C E M B E R 2 007

C L I N I C A L P E R F O R M A N C E O F H I G H L Y C R O S S -L I N K E D
POLYETHYLENES IN TOTAL HIP ARTHROPLASTY

is most likely due to the fact that the majority of the penetration
of the ball into the cup that occurs during the first six months of
use is due to creep deformation of the polyethylene rather than
to wearing away of material27. Since the rate of creep is not
markedly affected by the amount of cross-linking, the total
penetration during the first one to two years of use tends to be
comparable between the two types of polyethylene, even if one is
wearing substantially less than the other.
Because of this, in midterm studies of the highly crosslinked polyethylenes (with mean durations of follow-up of
approximately five years), investigators typically have excluded
the penetration data from the early, bedding-in period (i.e.,
when creep is substantial) in order to obtain a more accurate
measure of the actual steady-state wear rates. Consequently, the
percent reduction in wear due to elevated cross-linking has
tended to be greater in the midterm studies. Using a manual
measurement technique, Dorr et al.32 found that the wear rate
of thirty-seven Durasul acetabular liners (cross-linked with 9.5
Mrad [95 kGy]) at five years postoperatively was 55% lower
than that of thirty-seven polyethylene liners that had been
compression molded, packaged in an oxygen-free environment, and then gamma-sterilized (i.e., cross-linked) with the
standard range of 2.5 to 4 Mrad (25 to 40 kGy). Using the
computer-assisted method of Martell et al.49, DAntonio et al.31
found, after a mean duration of follow-up of 4.9 years, a 60%
reduction in the wear of fifty-six Crossfire liners (cross-linked
with 10.5 Mrad [105 kGy]) compared with the wear of fiftythree polyethylene liners that had been gamma-sterilized and
thereby cross-linked with 2.5 Mrad (25 kGy) in a nitrogen
environment and vacuum packaged. Furthermore, DAntonio
et al. stated that there were fewer osteolytic lesions and no
revisions in the Crossfire group.
Very favorable midterm results (at 4.1 to 7.2 years) also
were reported by Engh et al.35, who performed a randomized,
prospective study comparing the clinical performance of
seventy-six Marathon liners (DePuy Orthopaedics, Warsaw,
Indiana), cross-linked with 5 Mrad (50 kGy), with that of
ninety traditional ultra-high molecular weight polyethylene
liners that had been sterilized with gas plasma and therefore
were not cross-linked. Use of the method of Martell et al.49
showed the mean linear wear rate of the Marathon liners to be
95% lower than that of the non-cross-linked polyethylene
liners at a mean of 5.5 0.6 years postoperatively.
As indicated above, when the percent reductions in wear
are compared among clinical studies of different highly crosslinked polyethylenes, the type of polyethylene used for the
control group must be taken into account. This is due to the
fact that traditional polyethylene cups that are gamma-sterilized with the allowable range of 2.5 to 4 Mrad (25 to 40 kGy)
have a corresponding amount of cross-linking that, on the basis
of hip-simulator studies, would result in wear rates that were
about 50% lower (for cups sterilized with 2.5 Mrad) to 75%
lower (for those sterilized with 4 Mrad) than those of noncross-linked polyethylene cups (Marathon cups sterilized with
ethylene oxide or gas plasma)10. Thus, if a particular highly
cross-linked polyethylene is compared with a non-cross-linked

traditional polyethylene in a clinical study, it will show a greater

percent reduction in wear than it would if it is compared with
a gamma-sterilized (i.e., moderately cross-linked) traditional
polyethylene. This is illustrated by comparing the 95% reduction in wear relative to the wear of gas-plasma-sterilized (i.e.,
non-cross-linked) liners reported by Engh et al.35 with the 73%
reduction in the wear of Marathon liners relative to wear of
gamma-sterilized (i.e., moderately cross-linked) liners reported by Bitsch et al.34.
In several independent reviews of the literature, it was
found that osteolysis is rare in patients in whom the polyethylene cup is wearing at a rate of less than about 0.1 mm/yr, but
osteolysis becomes much more frequent and extensive as the
wear rate increases substantially above this threshold value55-58.
In three studies with a mean duration of follow-up of about
five years or longer, the mean rates of wear of Crossfire,
Durasul, and Marathon highly cross-linked polyethylenes
(Table I) all were well below 0.1 mm/yr31,32,35. On the other
hand, the osteolysis threshold of 0.1 mm/yr was established for
hips with traditional polyethylene linersi.e., those that either
were not cross-linked or were moderately cross-linked during
gamma sterilization. Some investigators have reported that the
mean particle size is smaller with highly cross-linked polyethylene and that, in equivalent volumes, smaller particles tend to
be more likely to cause osteolysis19,20,59. If that is correct, these
factors could lead to the osteolysis threshold being somewhat
lower for highly cross-linked polyethylenes.
We are aware of only one published case report of
clinically relevant osteolysis in a hip with a highly cross-linked
polyethylene liner (a Longevity liner)60. However, the hip in
question also had a forged-steel surface-grit-blasted femoral
component that, at revision, was found to be loose at the stemcement interface. Since the osteolysis in this hip occurred
endosteally around the loosened stem, with no acetabular lysis,
it is very possible that the lesions were primarily due to debris
produced at the stem-cement interface rather than from the
cross-linked liner. Continued close monitoring of patients with
highly cross-linked polyethylene components is essential to
determine if the improved wear resistance that has been
observed in the midterm, as summarized here, will translate
into a substantial reduction in the prevalence and severity of
osteolysis after long-term follow-up.
Second-Generation Highly
Cross-Linked Polyethylene
In order to maximize wear resistance without the reduced
mechanical properties associated with post-irradiation melting, second-generation highly cross-linked polyethylenes are
being developed with use of alternative methods to extinguish
free radicals. With one method, polyethylene that has been
cross-linked with radiation is soaked in vitamin E to extinguish
the residual free radicals61. Another method involves applying the cross-linking radiation in three doses, with annealing
after each dose to reduce the free radicals62. As with the firstgeneration highly cross-linked polyethylenes, it will require
years of close clinical follow-up to determine the safety and

2785
THE JOURNAL OF BONE & JOINT SURGERY JBJS.ORG
V O L U M E 89-A N U M B E R 12 D E C E M B E R 2 007

C L I N I C A L P E R F O R M A N C E O F H I G H L Y C R O S S -L I N K E D
POLYETHYLENES IN TOTAL HIP ARTHROPLASTY

effectiveness of these recently developed cross-linking methods

for reducing wear and/or osteolysis.
In conclusion, polyethylene wear of total hip prostheses
is affected by multiple factors, including the type of resin used,
the specific steps in the manufacturing process, the diameter of
the femoral head, the alignment of the acetabular and femoral
components, the weight and activity level of the patient, and
other factors. At the time of midterm follow-up, first-generation highly cross-linked polyethylene liners have appeared to
have decreased wear rates during clinical use and corresponding reductions in the prevalence and severity of osteolysis,
which may reduce the prevalence of implant loosening and the
need for revision. Despite improved wear characteristics, firstgeneration highly cross-linked polyethylene may be more
susceptible to fatigue fracture in the presence of improper
acetabular alignment and/or neck-liner impingement, particularly with the thinner liners that are used with larger-diameter
balls. This highlights the need for sound surgical technique.

Finally, surgeons should use caution when considering the use

of second-generation cross-linked polyethylenes, pending the
availability of clinical data on their safety and efficacy.

Cale A. Jacobs, PhD

Christian P. Christensen, MD
Lexington Clinic, 1221 South Broadway, Lexington, KY 40504. E-mail
address for C.A. Jacobs: cjaco@lexclin.com
A. Seth Greenwald, DPhil(Oxon)
Orthopaedic Research Laboratories, Lutheran Hospital, 1730 West 25th
Street, Cleveland, OH 44113
Harry McKellop, PhD
Department of Orthopaedic Surgery, University of California at Los
Angeles Orthopaedic Hospital, 2400 South Flower Street, Los Angeles, CA
90007

References

1. Laupacis A, Bourne R, Rorabeck C, Feeny D, Wong C, Tugwell P, Leslie K,

Bullas R. The effect of elective total hip replacement on health-related quality of
life. J Bone Joint Surg Am. 1993;75:1619-26.
2. 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.
3. Clohisy JC, Calvert G, Tull F, McDonald D, Maloney WJ. Reasons for
revision hip surgery. A retrospective review. Clin Orthop Relat Res.
2004;429:188-92.
4. Harris WH. Conquest of a worldwide human disease: particle-induced
periprosthetic osteolysis. Clin Orthop Relat Res. 2004;429:39-42.
5. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and
revision hip and knee arthroplasty in the United States from 2005 to 2030.
J Bone Joint Surg Am. 2007;89:780-5.
6. Affatato S, Bersaglia G, Rocchi M, Taddei P, Fagnano C, Toni A. Wear
behavior of cross-linked polyethylene assessed in vitro under severe
conditions. Biomaterials. 2005;26:3259-67.
7. Bragdon CR, Jasty M, Muratoglu OK, Harris WH. Third-body wear testing of a
highly cross-linked acetabular liner: the effect of large femoral head size in the
presence of particulate poly(methyl-methacrylate) debris. J Arthroplasty.
2005;20:379-85.
8. Harris WH, Estok D, Burroughs B, Muratoglu O, Plank G. In vitro comparison
of hip wear of Marathon and Durasul using both 32 and 38-mm head diameters.
J Arthroplasty. 2004;19:264.
9. Saikko V, Calonius O, Keranen J. Wear of conventional and cross-linked
ultra-high-molecular-weight polyethylene acetabular cups against polished and
roughened CoCr femoral heads in a biaxial hip simulator. J Biomed Mater Res.
2002;63:848-53.
10. McKellop H, Shen F, Lu B, Campbell P, Salovey R. Development of an
extremely wear-resistant ultra high molecular weight polyethylene for total hip
replacements. J Orthop Res. 1999;17:157-67.
11. McKellop H, Shen F, DiMaio W, Lancaster J. Wear of gamma-crosslinked
polyethylene acetabular cups against roughened femoral balls. Clin Orthop
Relat Res. 1999;369:73-82.
12. Parvizi J, Wade FA, Rapuri V, Springer BD, Berry DJ, Hozack WJ. Revision
hip arthroplasty for late instability secondary to polyethylene wear. Clin Orthop
Relat Res. 2006;447:66-9.
13. Greenwald AS, Bauer TW, Ries MD; Committee on Biomedical Engineering,
Committee on Hip and Knee Arthritis. New polys for old: contribution or caveat?
J Bone Joint Surg Am. 2001;83 Suppl 2(Pt1):27-31.
14. Muratoglu OK, Harris WH. Identification and quantification of irradiation
in UHMWPE through trans-vinylene yield. J Biomed Mater Res. 2001;56:
584-92.

15. Ries MD, Pruitt L. Effect of cross-linking on the microstructure and

mechanical properties of ultra-high molecular weight polyethylene. Clin Orthop
Relat Res. 2005;440:149-56.
16. Bradford L, Baker D, Ries MD, Pruitt LA. Fatigue crack propagation
resistance of highly crosslinked polyethylene. Clin Orthop Relat Res.
2004;429:68-72.
17. Oral E, Malhi AS, Muratoglu OK. Mechanisms of decrease in fatigue crack
propagation resistance in irradiated and melted UHMWPE. Biomaterials.
2006;27:917-25.
18. Holley KG, Furman BD, Babalola OM, Lipman JD, Padgett DE, Wright TM.
Impingement of acetabular cups in a hip simulator: comparison of highly crosslinked and conventional polyethylene. J Arthroplasty. 2005;20:77-86.
19. Endo M, Tipper JL, Barton DC, Stone MH, Ingham E, Fisher J. Comparison of
wear, wear debris and functional biological activity of moderately crosslinked
and non-crosslinked polyethylenes in hip prostheses. Proc Inst Mech Eng [H].
2002;216:111-22.
20. Fisher J, Bell J, Barbour PS, Tipper JL, Matthews JB, Besong AA, Stone MH,
Ingham E. A novel method for the prediction of functional biological activity of
polyethylene wear debris. Proc Inst Mech Eng [H]. 2001;215:127-32.
21. Gencur SJ, Rimnac CM, Kurtz SM. Fatigue crack propagation resistance of
virgin and highly crosslinked, thermally treated ultra-high molecular weight
polyethylene. Biomaterials. 2006;27:1550-7.
22. Puertolas JA, Medel FJ, Cegonino J, Gomez-Barrena E, Rios R. Influence of
the remelting process on the fatigue behavior of electron beam irradiated
UHMWPE. J Biomed Mater Res B Appl Biomater. 2006;76:346-53.
23. Hopper RH Jr, Engh CA Jr, Fowlkes LB, Engh CA. The pros and cons of
polyethylene sterilization with gamma irradiation. Clin Orthop Relat Res.
2004;429:54-62.
24. Hopper RH Jr, Young AM, Orishimo KF, Engh CA Jr. Effect of terminal
sterilization with gas plasma or gamma radiation on wear of polyethylene liners.
J Bone Joint Surg Am. 2003;85:464-8.
25. Sychterz CJ, Orishimo KF, Engh CA. Sterilization and polyethylene wear:
clinical studies to support laboratory data. J Bone Joint Surg Am.
2004;86:1017-22.
26. McKellop H, Shen FW, Lu B, Campbell P, Salovey R. Effect of sterilization
method and other modifications on the wear resistance of acetabular cups
made of ultra-high molecular weight polyethylene. A hip simulator study. J Bone
Joint Surg Am. 2000;82:1708-25.
27. Digas G, Karrholm J, Thanner J, Malchau H, Herberts P. Highly cross-linked
polyethylene in total hip arthroplasty: randomized evaluation of penetration
rate in cemented and uncemented sockets using radiostereometric analysis.
Clin Orthop Relat Res. 2004;429:6-16.

2786
THE JOURNAL OF BONE & JOINT SURGERY JBJS.ORG
V O L U M E 89-A N U M B E R 12 D E C E M B E R 2 007

C L I N I C A L P E R F O R M A N C E O F H I G H L Y C R O S S -L I N K E D
POLYETHYLENES IN TOTAL HIP ARTHROPLASTY

28. Manning DW, Chiang PP, Martell JM, Galante JO, Harris WH. In vivo
comparative wear study of traditional and highly cross-linked polyethylene in
total hip arthroplasty. J Arthroplasty. 2005;20:880-6.
29. Wannomae KK, Bhattacharyya S, Freiberg A, Estok D, Harris WH,
Muratoglu O. In vivo oxidation of retrieved cross-linked ultra-high-molecularweight polyethylene acetabular components with residual free radicals.
J Arthroplasty. 2006;21:1005-11.
30. Kurtz SM, Hozack W, Turner J, Purtill J, MacDonald D, Sharkey P, Parvizi J,
Manley M, Rothman R. Mechanical properties of retrieved highly cross-linked
Crossfire liners after short-term implantation. J Arthroplasty. 2005;20:840-9.
31. DAntonio JA, Manley MT, Capello WN, Bierbaum BE, Ramakrishnan R,
Naughton M, Sutton K. Five-year experience with Crossfire highly cross-linked
polyethylene. Clin Orthop Relat Res. 2005;441:143-50.
32. Dorr LD, Wan Z, Shahrdar C, Sirianni L, Boutary M, Yun A. Clinical
performance of a Durasul highly cross-linked polyethylene acetabular liner for
total hip arthroplasty at five years. J Bone Joint Surg Am. 2005;87:1816-21.
33. Heisel C, Silva M, dela Rosa MA, Schmalzried TP. Short-term in vivo wear of
cross-linked polyethylene. J Bone Joint Surg Am. 2004;86:748-51.
34. Bitsch R, Heisel C, Bal S, Dela Rosa M, Schmalzried T. Reduction of
osteolysis with crosslinked polyethylene at five years. Read at the Annual
Meeting of the American Association of Hip and Knee Surgeons; 2006 Nov 4;
Dallas, TX.
35. Engh CA Jr, Stepniewski AS, Ginn SD, Beykirch SE, Sychterz-Terefenko CJ,
Hopper RH Jr, Engh CA. A randomized prospective evaluation of outcomes after
total hip arthroplasty using cross-linked Marathon and non-cross-linked
Enduron polyethylene liners. J Arthroplasty. 2006;21(6 Suppl 2):17-25.
36. Katz JN, Losina E, Barrett J, Phillips CB, Mahomed NN, Lew RA, Guadagnoli
E, Harris WH, Poss R, Baron JA. Association between hospital and surgeon
procedure volume and outcomes of total hip replacement in the United States
Medicare population. J Bone Joint Surg Am. 2001;83:1622-9.
37. Losina E, Barrett J, Mahomed NN, Baron JA, Katz JN. Early failures of
total hip replacement: effect of surgeon volume. Arthritis Rheum. 2004;
50:1338-43.
38. Bradford L, Baker DA, Graham J, Chawan A, Ries MD, Pruitt LA. Wear and
surface cracking in early retrieved highly cross-linked polyethylene acetabular
liners. J Bone Joint Surg Am. 2004;86:1271-82.
39. Halley D, Glassman A, Crowninshield RD. Recurrent dislocation after
revision total hip replacement with a large prosthetic femoral head. A case
report. J Bone Joint Surg Am. 2004;86:827-30.
40. Burroughs BR, Rubash HE, Harris WH. Femoral head sizes larger than
32 mm against highly cross-linked polyethylene. Clin Orthop Relat Res.
2002;405:150-7.
41. Hermida JC, Bergula A, Chen P, Colwell CW Jr, DLima DD. Comparison of
the wear rates of twenty-eight and thirty-two-millimeter femoral heads on crosslinked polyethylene acetabular cups in a wear simulator. J Bone Joint Surg Am.
2003;85:2325-31.
42. Geller JA, Malchau H, Bragdon C, Greene M, Harris WH, Freiberg AA. Large
diameter femoral heads on highly cross-linked polyethylene: minimum 3-year
results. Clin Orthop Relat Res. 2006;447:53-9.
43. Kang JS, Park SR, Ebramzadeh E, Dorr LD. Measurement of polyethylene
wear in total hip arthroplastyaccuracy versus ease of use. Yonsei Med J.
2003;44:473-8.
44. Ebramzadeh E, Sangiorgio SN, Lattuada F, Kang JS, Chiesa R, McKellop
HA, Dorr LD. Accuracy of measurement of polyethylene wear with use of
radiographs of total hip replacements. J Bone Joint Surg Am. 2003;85:
2378-84.
45. Bragdon CR, Martell JM, Greene ME, Estok DM 2nd, Thanner J, Karrholm J,
Harris WH, Malchau H. Comparison of femoral head penetration using RSA and
the Martell Method. Clin Orthop Relat Res. 2006;448:52-7.
46. Livermore J, Ilstrup D, Morrey B. Effect of femoral head size on wear of the
polyethylene acetabular component. J Bone Joint Surg Am. 1990;72:518-28.
47. Dorr LD, Wan Z. Ten years of experience with porous acetabular
components for revision surgery. Clin Orthop Relat Res. 1995;319:191-200.
48. Devane PA, Bourne RB, Rorabeck CH, Hardie RM, Horne JG. Measurement
of polyethylene wear in metal backed acetabular cups. I. Three-dimensional
technique. Clin Orthop Relat Res. 1995;319:303-16.

49. Martell JM, Berkson E, Berger R, Jacobs J. Comparison of two and threedimensional computerized polyethylene wear analysis after total hip
arthroplasty. J Bone Joint Surg Am. 2003;85:1111-7.
50. Wan Z, Boutary M, Dorr LD. Precision and limitation of measuring twodimensional wear on clinical radiographs. Clin Orthop Relat Res.
2006;449:267-74. Erratum in: Clin Orthop Relat Res. 2006;450:274.
51. Bragdon CR, Estok DM, Malchau H, Karrholm J, Yuan X, Bourne R,
Veldhoven J, Harris WH. Comparison of two digital radiostereometric analysis
methods in the determination of femoral head penetration in a total hip
replacement phantom. J Orthop Res. 2004;22:659-64.
52. Bragdon CR, Malchau H, Yuan X, Perinchief R, Karrholm J, Borlin N, Estok
DM, Harris WH. Experimental assessment of precision and accuracy of
radiostereometric analysis for the determination of polyethylene wear in a total
hip replacement model. J Orthop Res. 2002;20:688-95.
53. Usrey MM, Noble PC, Rudner LJ, Conditt MA, Birman MV, Santore RF,
Mathis KB. Does neck/liner impingement increase wear of ultrahigh-molecularweight polyethylene liners? J Arthroplasty. 2006;21(6 Suppl 2):65-71.
54. Yamaguchi M, Bauer TW, Hashimoto Y. Deformation of the acetabular
polyethylene liner and the backside gap. J Arthroplasty. 1999;14:464-9.
55. McKellop HA. Wear assessment. In: Callaghan JJ, Rosenberg AG, Rubash
HE, editors. The adult hip. Philadelphia: Lippincott-Raven; 1998. p 231-46.
56. Dowd JE, Sychterz CJ, Young AM, Engh CA. Characterization of long-term
femoral-head-penetration rates. Association with and prediction of osteolysis. J
Bone Joint Surg Am. 2000;82:1102-7.
57. Oparaugo PC, Clarke IC, Malchau H, Herberts P. Correlation of wear debrisinduced osteolysis and revision with volumetric wear-rates of polyethylene: a
survey of 8 reports in the literature. Acta Orthop Scand. 2001;72:22-8.
58. Dumbleton JH, Manley MT, Edidin AA. A literature review of the association
between wear rate and osteolysis in total hip arthroplasty. J Arthroplasty.
2002;17:649-61.
59. Ries MD, Scott ML, Jani S. Relationship between gravimetric wear and
particle generation in hip simulators: conventional compared with cross-linked
polyethylene. J Bone Joint Surg Am. 2001;83(Suppl 2 Pt 2):116-22.
60. Bradford L, Kurland R, Sankaran M, Kim H, Pruitt LA, Ries MD. Early failure
due to osteolysis associated with contemporary highly cross-linked ultra-high
molecular weight polyethylene. A case report. J Bone Joint Surg Am.
2004;86:1051-6.
61. Oral E, Wannomae KK, Hawkins N, Harris WH, Muratoglu OK. Alphatocopherol-doped irradiated UHMWPE for high fatigue resistance and low wear.
Biomaterials. 2004;25:5515-22.
62. Dumbleton JH, DAntonio JA, Manley MT, Capello WN, Wang A. The basis
for a second-generation highly cross-linked UHMWPE. Clin Orthop Relat Res.
2006;453:265-71.
63. Rohrl S, Nivbrant B, Mingguo L, Hewitt B. In vivo wear and migration of
highly cross-linked polyethylene cups. A radiostereometry analysis study.
J Arthroplasty. 2005;20:409-13.
64. Martell JM, Verner JJ, Incavo SJ. Clinical performance of a highly crosslinked polyethylene at two years in total hip arthroplasty: a randomized
prospective trial. J Arthroplasty. 2003;18(7 Suppl 1):55-9.
65. Krushell RJ, Fingeroth RJ, Cushing MC. Early femoral head penetration of a
highly cross-linked polyethylene liner vs a conventional polyethylene liner.
A case controlled study. J Arthroplasty. 2005;20(7 Suppl 3):73-6.
66. Sychterz CJ, Engh CA Jr, Engh CA. A prospective, randomized clinical study
comparing Marathon and Enduron polyethylene acetabular liners: 3 year
results. J Arthroplasty. 2004;19:258.
67. Digas G, Karrholm J, Thanner J, Malchau H, Herberts P. Highly cross-linked
polyethylene in cemented THA: randomized study of 61 hips. Clin Orthop Relat
Res. 2003;417:126-38.
68. Bragdon CR, Barrett S, Martell JM, Greene ME, Malchau H, Harris WH.
Steady-state penetration rates of electron beam-irradiated, highly cross-linked
polyethylene at an average 45-month follow-up. J Arthroplasty. 2006;21:
935-43.
69. Hopper RH Jr, Young AM, Orishimo KF, McAuley JP. Correlation between
early and late wear rates in total hip arthroplasty with application to the
performance of Marathon cross-linked polyethylene liners. J Arthroplasty.
2003;18(7 Suppl 1):60-7.