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Proceedings of the ASME 2008 Summer Bioengineering Conference (SBC2008)

June 25-29, Marriott Resort, Marco Island, Florida, USA

SBC2008-192878
SHEAR FATIGUE TESTING OF ALL-POLYETHYLENE PATELLAR COMPONENTS

Alex P. Stoller, Kimberly D. Mimnaugh

Corporate Research
Zimmer, Inc.
Warsaw, IN

INTRODUCTION
Many total knee arthroplasty patellar implants are designed as allpolyethylene components with either 1 or 3 pegs for cement fixation.
Failure of patellar components due to peg fracture is rare, but has been
reported [1-4]. Excessive shear forces due to high patient weight
and/or activity level have been implicated as potential causes of these
rare failures. In order to assist with the design of all- polyethylene
patellar components, a test method was developed to replicate the peg
shear failure mode observed clinically. Peak patellofemoral forces
have been predicted during mid-flexion activities such as stair
climbing or sitting [5], therefore testing utilized patellofemoral contact
load magnitudes consistent with these activities. The Natural-Knee
II System (N-K II) all poly patellar components manufactured from
Durasul Highly Crosslinked Polyethylene were chosen for testing as
a representative patella component design.

N-K II patellar instrument clamp or manual hand pressure was used to


compress the patella against the foam block while the cement cured.

Figure 1. Patella component setup


The foam block was then fixed to the biaxial load frame and aligned
with a custom stainless steel fixture that had the concave profile of a
patellar component. To eliminate possible variation due to patella
orientation, all components were rotated such that the shear force was
aligned between 2 of the 3 pegs as shown in Figure 2. The components
were immersed in deionized water maintained at 37 C to simulate
normal body temperature. The test setup is shown in Figure 3.

METHODS
Sixteen N-K II Durasul all poly patellar components, size 0, 7
mm thick, were obtained for testing. Tests were conducted using a
servohydraulic load frame (MTS, Eden Prairie, MN) equipped with
both vertical and horizontal actuators. Each patella was cemented to a
block of polyurethane foam (LAST-A-FOAM FR-3730 Rigid Foam,
General Plastics, Tacoma, WA) using PALACOS R bone cement
(Heraeus Kulzer GmbH) as shown in Figure 1. The foam was
prepared using appropriate surgical instruments to drill the fixation
holes to accommodate the peg geometry. All patellae were cemented
in an onlay configuration rather than inset into the foam block, as
insetting has been previously shown to produce higher shear strength
[6]. The cement was applied to the foam and the backside of the
patella approximately 4 minutes after the start of mixing. Either the

Figure 2. Shear force orientation

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possible predictor variable (in addition to applied shear load) for


fatigue life. This analysis found no significant effect on fatigue life
due to cement mantle thickness. Similarly, the cement pressurization
technique (clamp instrument vs. hand pressure) did not affect the
results.
1950
Shear Force (N)

1900
1850
1800
1750
1700
1650
1.0E+03

Figure 3. Test setup


The patella fixture was used to apply simultaneous compressive
and shear loading. The compressive load was sinusoidal at a
frequency of 3 Hz and a peak magnitude of 2669 N (600 lb) for all
samples. The load magnitude represented 3*BW for an 890 N (200 lb)
individual. The shear load was sinusoidal at 3 Hz and in phase with the
compressive load such that the peak shear force occurred
simultaneously with the peak compressive force. A min/max load
ratio of R = 0.1 was used for both compressive and shear loading.
Peak shear force magnitude ranged from 1700-1900 N (385-425 lbs).
Fractures occurring between cycle counts of 0 to 2 million cycles were
of primary interest, representing over 10 years of stair climbing
activity at the 75th percentile level among orthopaedic patients [7].
The longest postoperative occurrence of patella peg fracture recorded
in the literature is 10 years [3].

1.0E+04

1.0E+05
Cycles

1.0E+06

1.0E+07

Figure 5. Shear fatigue data


DISCUSSION
Peg fracture, as observed for the N-K II Durasul components
tested here, is consistent with a small number of clinical fractures that
have been reported in the literature for all poly patellar components of
similar design [1-4]. Initially, static shear testing was performed in a
manner similar to previously published reports [6,8]. However, the
static shear testing did not result in the clinically relevant failure mode
of peg shear, instead producing some combination of peg pull-out or
foam failure similar to the results obtained by Rosenstein et al [6].
Therefore, the cyclic nature of the shear loading appears important in
producing clinically relevant failures at the cement-implant interface.
Although the testing was not intended to precisely replicate in
vivo loading conditions, the shear fatigue strength obtained from the
test results far exceeds the in vivo load magnitudes predicted by the
literature. Peak patella shear forces have been estimated to be
approximately 30% of the patellofemoral contact force [9]. By
comparison, the estimated 2 million cycle shear fatigue strength for the
N-K II Durasul patella exceeded 60% of the applied patellofemoral
contact force.
Further fatigue testing is currently ongoing to investigate the
possible effects of factors such as component design, shear force
orientation relative to the fixation pegs, polyethylene type, and cement
technique on patellar component shear strength. The shear fatigue test
method described here should provide an excellent tool for evaluating
and improving shear strength in all-polyethylene patellar component
designs.

RESULTS
The test method was successful in replicating the peg shear
failure mode at the patella-cement interface. Each of the 16 patellar
components tested failed at the implant-cement interface. The
predominant failure mode was shear fracture of all 3 fixation pegs
(Figure 4), occuring in all but one test sample. In a single case, one
peg sheared and two pegs pulled out of the cement mantle without
fracturing; however the fatigue life for this sample was not an outlier
compared to the rest of the test group. The fatigue life data is shown in
Figure 5, along with a log-linear regression line.

REFERENCES
1. Francke EI et al, J. Arthroplasty 15(2), 2000, pp. 234-237.
2. Huang C et al, J. Arthroplasty 14(8), 1999, pp. 940-944
3. Shafi M et al, Knee Surg Sports Traumatol Arthrosc. 13(6), 2005,
pp. 472-475.
4. Edwards TB et al, Orthopedics 25, 2002, pp. 856-857.
5. Powers CM et al, Clin. J. Sports Med. 14, 2004, pp. 206-214.
6. Rosenstein AD et al, Knee 14(3), 2007, pp 194-197.
7. Morlock M et al, J. Biomechanics 34, 2001, pp. 873-881.
8. Clarke MT et al, AAOS 2007, Poster No. 115.
9. Browne C et al, Knee 12(2), 2005, pp. 81-88.

Figure 4. Typical fractured patellar component


Some variation in cement mantle thickness was observed during
testing (0-0.7 mm (0.03 in)). A multivariate regression analysis was
performed in which cement mantle thickness was included as a

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