Abstract
Introduction
Polyetheretherketone (PEEK) has been proposed as an implant material for femoral total knee arthroplasty (TKA) components. Potential clinical advantages of PEEK over standard cobalt chrome alloys include modulus of elasticity and subsequently reduced stress shielding potentially eliminating osteolysis, thermal conduction properties allowing for a more natural soft tissue environment, and reduced weight enabling quicker quadriceps recovery. Manufacturing advantages include reduced manufacturing and sterilization time, lower cost, and improved quality control. Currently, no PEEK TKA implants exist on the market. Therefore, evaluation of mechanical properties in a pre-clinical phase is required to minimize patient risk.
The objectives of this study include evaluation of implant fixation and determination of the potential for reduced stress shielding using the PEEK femoral TKA component.
Methods and Materials
Experimental and computational analysis was performed to evaluate the biomechanical response of the femoral component (Freedom Knee, Maxx Orthopedics Inc., Plymouth Meeting, PA; Figure 1).
Fixation strength of CoCr and PEEK components was evaluated in pull-off tests of cemented femoral components on cellular polyurethane foam blocks (Sawbones, Vashon Island, WA). Subsequent testing investigated the cemented fixation using cadaveric distal femurs. The reconstructions were subjected to 500,000 cycles of the peak load occurring during a standardized gait cycle (ISO 14243-1). The change from CoCr to PEEK on implant fixation was studied through computational analysis of stress distributions in the cement, implant, and the cement-implant interface. Reconstructions were analyzed when subjected to standardized gait and demanding squat loads.
To investigate potentially reduced stress shielding when using a PEEK component, paired cadaveric femurs were used to measure local bone strains using digital image correlation (DIC). First, standardized gait load was applied, then the left and right femurs were implanted with CoCr and PEEK components, respectively, and subjected to the same load. To verify the validity of the computational methodology, the intact and reconstructed femurs were replicated in FEA models, based on CT scans.
Results
The cyclic load phase of the pull-off experiments revealed minimal migration for both CoCr and PEEK components, although after construct sectioning, debonding at the implant-cement interface was observed for the PEEK implants. During pull-off from Sawbones the ultimate failure load of the PEEK and CoCr components averaged 2552N and 3814N respectively.
FEA simulations indicated that under more physiological loading, such as walking or squatting, the PEEK component had no increased risk of loss of fixation when compared to the CoCr component. Finally, the DIC experiments and FEA simulations confirmed closer resemblance of pre-operative strain distribution using the PEEK component.
Discussion
The biomechanical consequences of changing implant material from CoCr to PEEK on implant fixation was studied using experimental and computational testing of cemented reconstructions. The results indicate that, although changes occur in implant fixation, the PEEK component had a fixation strength comparable to CoCr. The advantage of long term bone preservation, as the more compliant PEEK implant is able to better replicate the physiological loads occurring in the intact femur, may reduce stress shielding around the distal femur, a common clinical cause of TKA failure.
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