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. 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.Introduction
Methods and Materials
In patients presenting with significant ligamentous instability/insufficiency and/or significant varus/valgus deformity of the knee, reproduction of knee alignment and soft tissue stability continues to be a difficult task to achieve. These complex primary total knee arthroplasty (TKA) candidates generally require TKA systems incorporating increasing levels of constraint due to the soft-tissue and/or bone deficiencies. In addition, achievement of “normal” gap symmetry through physiologic kinematics is challenging due to the complexity of the overall correction. Advancements in TKA design have not fully addressed the negative consequences of the increased forces between the degree of component constraint, the femoral box, and the tibial post. The purpose of this early feasibility study was to introduce the design characteristics of a primary TKA system that incorporates progressive constraint kinematics using a low profile trapezoidal femoral box, and to assess the short-term clinical and radiographic results of this patient cohort. We retrospectively evaluated 22 consecutive, non-selected, complex primary TKA patients with a minimum of 3-years follow-up and varus deformity of > 20 degrees or valgus deformity of >15 degrees. The Progressive Constraint Kinematics® Knee System (PCK, MAXX Orthopedics, Norristown, PA) was used and provides a variable constraint profile, from high constraint in extension to less constraint in flexion through a novel trapezoidal femoral box. We evaluated patient demographics, pre- and post-operative serial radiography, range of motion (ROM), and total Knee Society Score (KSS – total score). General descriptive statistics and paired t-Test to assess the difference between means at p <0.05 level of significance.INTRODUCTION
METHODS
