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Biomechanical implant fixation of CoCrMo coating inferior

to titanium coating in a canine implant model

Stig S. Jakobsen, Jorgen Baas, Thomas Jakobsen, Kjeld Soballe


Orthopaedic Research Laboratory, Department of Orthopaedics, Aarhus University Hospital, Norrebrogade 44,
Build. 1a., 8000 Aarhus C, Denmark

Received 26 November 2008; revised 9 September 2009; accepted 2 October 2009


Published online 2 February 2010 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jbm.a.32709

Abstract: The use of CoCrMo in orthopedic surgery is decrease in bone volume density around CoCrMo implants
not new, and CoCrMo (cobalt–chromium–molybdenum) is was observed. Insertions of CoCrMo implants are associ-
well tolerated. Nevertheless, the alloy is still considered ated with a disturbance of the delicate peri-implant milieu.
less biocompatible than titanium. We therefore wanted to Even from implants not subjected to any mechanical
explore the biocompatibility of CoCrMo by investigating forces, metal ions are liberated and result in intra- and
the biomechanical implant fixation and implant osseointe- extracellular accumulation in the immediate implant vicin-
gration of CoCrMo (ASTM F-75) porous bead-coated and ity, presenting a likely explanation for our findings. A 40%
titanium (ASTM F-136) porous bead-coated implants. In 10 reduction of initial implant fixation could prove to be seri-
dogs, the two implant types were inserted into the proxi- ous because initial implant fixation is critical for long-term
mal part of the humerus. Implant sites were overdrilled, performance. The choice between titanium alloy and
leaving an empty 0.75-mm gap between implant and sur- CoCrMo should, however, ultimately be governed by a
rounding bone. The implants were observed for 6 weeks comprehensive review of all factors influencing clinical
and were evaluated by biomechanical push-out test and implant survival. Ó 2010 Wiley Periodicals, Inc. J Biomed
histomorphometry. We found a statistically significant 40% Mater Res 94A: 180–186, 2010
decrease in the biomechanical fixation of CoCrMo porous
bead-coated implants compared with titanium porous Key words: biocompatibility; CoCrMo; titanium; osseo-
bead-coated implants. Implant osseointegration was com- integration; implant fixation
parable between the two implants; however, a slight

INTRODUCTION will bead-coated CoCrMo perform compared with


bead-coated titanium implants?’’9
Metal-on-metal hip bearings made of CoCrMo The increasing use of metal-on-metal and hip resur-
(cobalt–chromium–molybdenum) alloy possess excel- facing implants has exposed many patients to
lent wear properties1–4 and are a tempting choice for CoCrMo and heightened concerns about toxicity.
young and active patients. The use of CoCrMo in or- Adverse effects from CoCrMo could be observed as a
thopedic surgery is not new,5 and CoCrMo is well result of the released metal ions (Cr3þ, Co2þ, Ni2þ,
tolerated.6 Nevertheless, the alloy is still considered Cr6þ), and nanosized wear particles [oxides (Cr2O3,
less biocompatible than titanium,7 and on grit- CoO, Al2O3), hydroxides (CrOH3, CoOH2, etc), and
blasted surfaces implant fixation has previously been metals (CoCrMo)] released from the implants.2,10–13
reported to be poorer for CoCrMo alloys versus The large amount of metal nanoparticles and the pre-
titanium alloys.7,8 Bead-coated CoCrMo implants, sumed high levels of metal ions in the tissues sur-
however, performed well compared with grit-blasted rounding hip prostheses have raised concerns regard-
titanium implants, leaving the question open ‘‘how ing carcinogenicity,14,15 hypersensitivity,16 local tissue
toxicity,17 inflammation,18 and genotoxicity.19
CoCrMo implant surfaces and metal debris may
also be involved in the complex cellular and molecu-
Correspondence to: S. S. Jakobsen; e-mail: stig.jakobsen@ lar response in osseous wound healing by inducing
ki.au.dk
Contract grant sponsor: DePuy Orthopaedics, Inc., Warsaw,
cytokine response20,21 and affecting proliferation
IN, USA and necrosis/apoptosis.22,23 Metal ions can theoreti-
cally be released due to mechanically wear (mainly
Ó 2010 Wiley Periodicals, Inc. bearing surfaces), or to macrophage-dependent
BIOMECHANICAL IMPLANT FIXATION IN A CANINE IMPLANT MODEL 181

Figure 1. X-ray films of implant positioning sites. The two implant types were inserted in the cancellous bone (CoCrMo
porous bead-coated and titanium porous bead-coated implants). [Color figure can be viewed in the online issue, which is
available at www.interscience.wiley.com.]

dissolution of wear debris and implant surface.24 inserted into the cancellous bone and systematically
Implants not subjected to any mechanical stress will rotated, with a random start, between implant sites (prox-
still release metal ions that affect local tissue24–26 and imal, distal, left, and right) (Fig. 1). Approval was obtained
accumulate in more distant organs such as liver and from our Institutional Animal Care and Use Committee
prior to performing the study. Based on previous experi-
kidney.27 In the peri-implant space, metal ions can
ments in comparable models and an estimated clinically
influence cells involved in the complex cellular and
significant difference, standard deviation was set to 50%
molecular response in osseous wound healing. In and MIREDIF to 50%. Significance level was set to 0.05
osseous wound healing, several cell types, including and power 0.8. Based on the formula n 5 2(t2a þ tb)28
osteoblasts, osteoclasts, and macrophages, all play SD2/MIREDIF2 5 7.84, 10 animals should be included,
pivotal roles because of their ability to affect the allowing for a few drop-outs.
healing response in a deleterious way, essentially
making an implant fail.
We hypothesized that titanium porous bead- Animals and surgical procedure
coated implants would prove a superior overall
implant fixation compared with CoCrMo porous Under sevoflurane general anesthesia, using sterile tech-
nique, the proximal part of humerus was exposed through
bead-coated implants. The purpose of this study was
a lateral extraarticular approach. Two Kirschner (K) wires
to investigate biomechanical implant fixation, tissue-
were inserted perpendicular to the surface 17 mm apart.
to-implant contact, and tissue density around The most proximal K wire was inserted at the level of the
CoCrMo porous bead-coated and titanium porous greater tubercle. The K wires were used to guide a 7.5-mm
bead-coated implants. canulated drill making a 13.0-mm-deep hole. To create a
0.75-mm gap between implant and surrounding bone,
overdrilling was performed. The top washer and the foot-
MATERIALS AND METHODS plate centralized the implant in the hole (Figs. 1 and 2).
Drilling was performed at two rotations per second to pre-
vent thermal trauma to the bone. All bone debris and soft
Design tissue were removed from the drill hole, and the implant
with the footplate mounted was inserted, leaving the gap
The study was designed as an animal experiment with between implants and bone tissue empty. Finally, the top
10 skeletally mature Labrador dogs. Mean body weight washer was mounted and soft tissue closed in layers. Pre-
was 32.3 kg (25–39 kg). The two implant types were and postoperatively, the dogs were given one dose of

Journal of Biomedical Materials Research Part A


182 JAKOBSEN ET AL.

Figure 2. Schematic overview. (a) Bone. (b) Marrow. [Color figure can be viewed in the online issue, which is available
at www.interscience.wiley.com.]

cefuroxim, 1.5 g intravenously, as antibiotic prophylaxis. A section of 6.5 mm was prepared for histomorphometry.
fentanyl transdermal patch (75 lg/h) lasting 3 days was The specimens were dehydrated in graded ethanol
given as postoperative analgesic treatment. The dogs were (70–100%) containing basic fuchsin and embedded in
allowed full weight bearing postoperatively. methylmetacrylate (Technovit 7200 VCL; Exact Apparat-
bau, Nordenstedt, Germany). Four vertical, uniform, ran-
dom sections were cut with a hard-tissue microtome
The implants (KDG-95; MeProTech, Heerhugowaard, The Netherlands)
around the center part of each implant as described by
Cylindrical porous bead-coated implants were made of Overgaard et al.30 parallel to the natural vertical axis of
titanium alloy (Ti-6Al-4V, ASTM F-136) and CoCrMo alloy the implant. The 50-lm sections were counterstained with
(ASTM F-75) with a nominal diameter of 6.0 mm and 2% light green (BDH Laboratory Supplies, Poole, UK) and
length of 10.0 mm (DePuy Orthopaedics, Warsaw, IN). then mounted on glass.31 This preparation provides red
The PoroCoat1 porous coating obtained by sintering staining of noncalcified tissue and green staining of calci-
spherical beads has an average pore size of 250–300 lm fied tissues, such as woven and lamellar bone.
and porosity range of 40–50%. The average thickness of
the porous bead coating was 0.75 mm. The implants were
passivated (ASTM A967-05), packaged separately, and Biomechanical testing
gamma sterilized.
Implants were tested to failure by blinded axial push-
out test on a MTS Bionics Test Machine (Instrom, High
Specimen preparation Wycombe, UK). The specimens were placed on a metal
support jig with a 7.4-mm diameter central opening. The
After 6 weeks’ observation, the animals were sacrificed implant was centralized over the opening, thereby assur-
with an overdose of hypersaturated barbiturate, and the ing a 0.7-mm distance between the implant and the sup-
proximal part of humerus was excised and cleaned and port jig as recommended by Dhert et al.32 The direction of
thereafter stored at 2208C. The outermost 0.5 mm of the loading was from the cortical surface inward. A preload of
implant-bone specimen was cut off and discarded. The 2 N was applied to standardize contact conditions before
rest of the implant with surrounding bone was divided initiating loading. We used a displacement rate of
into two sections perpendicular to the long axis of the 5 mm/min with a 2500 N load cell. Load and deformation
implant with a water-cooled silicon carbide cut-off wheel were registered by a personal computer. Each specimen’s
(Accutom-50, Stuers A/S, Rødovre, Denmark). The outer- length and diameter were measured with a micrometer
most section was cut to a thickness of 3.0 mm and stored and used to normalize push-out parameters. Ultimate
at 2208C pending biomechanical testing.29 The innermost shear strength (MPa) was determined from the maximal

Journal of Biomedical Materials Research Part A


BIOMECHANICAL IMPLANT FIXATION IN A CANINE IMPLANT MODEL 183

TABLE I k is the number of double measurements and d is the


Reproducibility of Histomorphometry difference between the first and second assessments. Then,
Fibrous Tissue Bone (New) CV % is calculated as follows: CV % 5 (s/x) 100, where x
is the mean value of the first and second assessments
Zone 1 (a) 3% 15% (Table I).
Zone 2 (v) 47% 7%
Zone 2 (a) 55% 3%
Statistics
Variation coefficient (CV %).
All the variations are well below the expected range.
The large CV % on fibrous tissue in zone 2 is caused by a Histological and biomechanical data were analyzed with
low absolute amount of fibrous tissue here. The very low two-way ANOVA with regard to implant position (upper–
CV % from zone 1 confirms the fact that it is possible to lower) and group (CoCr PC and titanium PC). When a
readily identify fibrous tissue. statistically significant difference was found within the
groups, a Student’s t test comparison of the groups fol-
lowed. The data were presented as means with 95% confi-
force applied until failure of the bone-implant interface. dence intervals (CIs), and p values less than 0.05 were con-
Apparent stiffness (MPa/mm) was obtained from the sidered statistically significant.
slope of the linear section of the curve. Energy absorption
(J/m2) was calculated from the area beneath the curve
until failure. All push-out parameters were normalized by RESULTS
the cylindrical surface area of the transverse implant sec-
tion tested.33
No postoperative complications were seen, and all
dogs were fully weight bearing within 3 days of sur-
Histological evaluation gery. All animals completed the 6-week observation
period. At the implant sites, there were no clinical
Blinded histomorphometrical analysis was done using a signs of infection.
stereological software program (CAST-grid Olympus
Denmark A/S, Ballerup, Denmark). Fields of vision from a
Biomechanical results
light microscope were captured on a computer monitor,
and a user-specified grid was superimposed on the micro-
scopic fields. Four vertical sections representative of each We found a decrease in maximum shear strength
implant were analyzed and cumulated.30,34 The specimen (43%), total energy absorption (41%), and maximum
preparation procedure and the grid system made it possi- shear stiffness (44%). By gross observation, both
ble to calculate unbiased estimates even though anisotropy implant groups were well anchored in the bone, but
in cancellous bone exists. the titanium PC implants had better biomechanical
With the aid of the software, we defined two regions of fixation than the CoCrMo implants in all parameters
interest: A zone 1 from implant core surface and 250 lm (Table II).
outward, and a zone 2 from a line between the core
implant and ‘‘the outermost implant bead’’ and 750 lm
outward (Fig. 2). Histological results
In zones 1 and 2, tissue-implant contact was defined as
the fraction of the implant surface covered with a particu-
Surprisingly, we did not observe any statistically
lar tissue (bone, fibrous tissue, marrow space) and esti-
significant differences between titanium PC and
mated using sine-weighted lines.34 In zone 2, tissue
volume fractions were estimated by point counting.35,36 CoCr PC (Fig. 3). We observed a tendency toward
Double measurements were carried out to calculate the decreased bone tissue coverage and increased
intraobserver variation. The measurements were carried fibrous tissue coverage in zone 1 for titanium
out by the same person using identical equipment and implants. The formation of new bone in the gap was
P 2
setup. The CE was calculated as: S25 (1/(2k)) d , where comparable between the implants, and almost no

TABLE II
Biomechanical Implant Fixation
Total Energy Maximum
Biomechanical Maximum Shear Absorption Shear Stiffness
Parameters Strength (MPa) (kJ/m2) (MPa/mm)

CoCrMo PC 2.37 [1.50–3.24] 0.39 [0.27–0.50] 12.14 [7.20–17.08]


Titanium PC 4.15 [2.48–5.82] 0.66 [0.41–0.91] 21.61 [12.34–30.88]
p 5 0.04 p 5 0.01 p 5 0.04

Data are presented as mean with 95% CI.

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184 JAKOBSEN ET AL.

Figure 3. Representative photomicrographs of 50-lm sections from the same animal. The samples were stained with ba-
sic fuchsin and counterstained with 2% light green. Implant appears as black, marrow as red, and bone as green. Note
that no obvious difference between titanium (A, B) and CoCrMo (C, D) exists. [Color figure can be viewed in the online
issue, which is available at www.interscience.wiley.com.]

fibrous tissue was formed (zone 2). Results of the all implants were put into the healthy bone of young
histological analysis are given in Table III. dogs. The model lacks clinically relevant influences
like joint fluid pressure and direct load. This is, how-
ever, a basic experimental model that is more con-
DISCUSSION trolled than other weight-bearing models.33
Dissoluted metal ions from the implant surface are
The purpose of this study was to investigate the known to affect peri-implant cells, osteoblasts in
biocompatibility of CoCrMo porous bead-coated and particular.24,26 MG-3 osteoblast, fibroblasts, and lym-
titanium porous bead-coated implants by evaluating phocytes proliferation is susceptible to metal ions,
biomechanical implant fixation and implant osseo- particularly those of vanadium, nickel, and cobalt.23
integration. Apoptosis and/or necrosis is induced in a wide
We found a statistically significant decrease (p 5 range of cells by metal ions liberated from implant
0.04, p 5 0.01, p 5 0.04) in biomechanical fixation for
CoCrMo porous bead-coated implants compared TABLE III
with titanium porous bead-coated implants, but with Histological Results
comparable histological parameters.
Bone (New) Fibrous Tissue
Our experimental 0.75-mm gap model was
designed to imitate the close interaction between Zone 1 (2250 to 0 lm)
cementless joint replacement alloys and bone form- Area fractions in percent
ing/remodeling processes in cancellous bone. We CoCrMo PC 6.8 [3.5–10.1] 64.7 [52.5–76.9]
Titanium PC 4.3 [1.8–7.5] 71.8 [57.5–86.1]
used a clinically well-proven implant coating for p 5 0.10 p 5 0.26
uncemented implants, PoroCoat1, where the only Zone 2 (0–750 lm)
difference between the coatings was the metal com- Area fractions in percent
position. Canine cancellous epiphyseal bone was CoCrMo PC 15.6 [10.6–20.6] 3.6 [0.9–6.3]
chosen because of its close resemblance to the bone Titanium PC 16.2 [11.2–21.2] 8.4 [0.7–16.7]
p 5 0.93 p 5 0.20
into which cementless joint replacements are usually Zone 2 (0–750 lm)
implanted. Canine bone reflects the composition, Volume fractions in percent
density, and quality of human bone better than does CoCrMo PC 18.2 [12.5–23.9] 0.38 [0–0.9]
that of most other animals.37 No animal model, how- Titanium PC 21.0 [13.8–28.2] 1.38 [0–4.1]
ever, gives complete information about the effect of p 5 0.57 p 5 0.21
a given alloy on human osteogenesis. Canine bone Data are presented as mean with 95% CI. None of the
remodels much faster than does human bone, and comparisons was statistically significant. n 5 10.

Journal of Biomedical Materials Research Part A


BIOMECHANICAL IMPLANT FIXATION IN A CANINE IMPLANT MODEL 185

material.38 Released Co and V are more cytotoxic12 press-fit implant surface is in bone contact.41 We
than Al, Fe, Cr, and Mo; however, these ions seem believe that an implants ability to provide early, sta-
to suppress osteoblast proliferation more than fibro- ble, and osseous fixation is important and predictive
blast proliferation.23 Furthermore, Puleo et al. dem- of implant survival, as indicated by numerous radio
onstrated that osteoblasts grow faster on titanium stereometric analysis studies.42,43 In this regard, our
alloy than on CoCrMo-alloy.39 Finally, Baldwin and results show that CoCrMo is inferior to titanium,
Hunt demonstrated a sustained proinflammatory and to determine the exact failure mechanism for
response by CoCr alloy in a soft tissue model, and CoCrMo implants the bone-implant interface must
Jinno et al. demonstrated an inferior implant fixation be studied on a submicroscopically level. The mate-
of grit-blasted CoCr implants compared with grit- rial composition of an implant also determines other
blasted titanium implants. Based on these results, an important properties, such as elastic modulus and
expected outcome would be inferior overall perform- wear resistance, which were not subject to evaluation
ance of CoCrMo implants compared with titanium in this model. The choice between titanium alloy
implants. and CoCrMo should ultimately be governed by a
We found that the biomechanical fixation of the comprehensive review of all factors influencing clini-
CoCrMo porous-coated implants was 40% lower cal implant survival.
than the titanium porous-coated implants, but bone-
to-implant contact was comparable. This is consistent
with a previous report in which only biomechanical CONCLUSIONS
fixation and not osseointegration was affected by
grit-blasted CoCrMo surfaces.8 The lack of difference We found a statistically significant 40% decrease
in terms of bone-implant contact and peri-implant in the biomechanical fixation of CoCrMo porous
bone volume could be explained by either a bead-coated implants compared with titanium po-
decreased intimate bone-implant adhesion on a sub- rous bead-coated implants. Insertions of CoCrMo
microscopic level or by a decreased bone quality. implants are associated with a disturbance of the
Coating the implant surface with hydroxyapatite delicate peri-implant milieu, presenting a likely ex-
reverses the negative effect of CoCrMo on implant planation for our findings. A 40% reduction in initial
fixation compared with titanium implants coated implant fixation could prove to be serious problem
with hydroxyapatite, further incriminating CoCrMo because initial implant fixation is critical for long-
surfaces.40 Secretion of extracellular matrix proteins term performance.
and mineralization have previously been shown to
be decreased by CoCrMo alloy compared with tita- The authors thank laboratory technicians Jane Pauli and
nium, potentially creating a weak bone quality and/ Annette Milton for excellent laboratory work with the his-
or bone-implant interface.28 Moreover, the released tological sections and Niels Trolle Andersen for valuable
levels of metal ions may be too low to induce detect- guidance with statistics.
able changes in bone density, but large enough to
affect the bone-implant interface or the bone quality.
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Journal of Biomedical Materials Research Part A

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