Introduction. Despite decades of clinical research in artificial joints and underlying failure mechanisms, systematical and reproducible identification of reasons for complications in total knee replacements (TKR) remains difficult. Due to the complex dynamic interaction of implant system and biological situs, malfunction eventually leading to failure is multifactorial and remains not fully understood. The aim of present study was to evaluate different TKR designs and positions with regard to joint kinematics and stability under dynamic conditions by using a robot-based hardware-in-the-loop (HiL) setup. Material & methods. An industrial 6-axis robot with 6-axis force-torque sensor mounted into its end-effector moved and loaded real, commercially available TKR (bicondylar, cruciate-retaining) that were in virtual interaction with a subject-specific computational multibody model representing the anatomical situs of the knee joint while performing passive seated deep knee flexion. The subject-specific musculoskeletal multibody model (MMB) included rigid bones of the lower right extremity. Bone and cartilage geometries were reconstructed from MRT/ CT data sets preserving anatomical landmarks and allowing for the calculation of inertial properties. M. quadriceps femoris was modeled as single passive tensile force elements. Knee ligaments were modelled as elastic spring elements with a nonlinear force-displacement characteristic. Providing the flexion angle, the robot moved and loaded the mounted femoral implant component with respect to the tibial component while being in continuous interaction with the MMB. Several influencing parameters like implant position (internal/external rotation, varus/valgus alignment) and design (fixed vs. mobile bearing, tibia-insert height) as well as ligament insufficiency and joint loading on joint kinematics and stability was systematically analysed. Results. Improper implant positioning caused joint instability, which was demonstrated in higher magnitudes of the relative kinematics. Negative effects by incorrect implant positioning could be partially compensated by a mobile bearing design. However, this was accompanied with an increase in tibiofemoral contact forces. High correlation of tibia-insert height on ligament and contact force was found. After releasing ligament structures, lower tibiofemoral contact forces and joint opening during deep knee flexion were observed. Conclusion. By means of HiL simulation different clinical and technical parameters of TKR were evaluated in a systematical and reproducible fashion under physiological-like boundary conditions with regard to joint kinematics and stability. The proposed HiL test setup combining robot-based testing with MMBs can contribute to deeper understanding of knee joint function and improvement of total knee implant systems. Acknowledgement. The authors would like to thank the Deutsche Forschungsgemeinschaft (grant numbers: WO WO 452/8-1, BA 3347/3-1 and KL 2327/4-1) for supporting the project

Summary Statement. Wear of total knee replacement (TKR) is a clinical concern. This study demonstrated low-conformity moderately cross-linked-polyethylene fixed bearing TKRs showed lower volumetric wear than conventional-polyethylene curved fixed bearing TKRs highlighting potential improvement in TKR performance through design and material selection. Introduction. Wear of total knee replacement (TKR) continues to be a significant factor in the clinical performance of the implants. Historically, failure due to delamination and fatigue directed implant design towards more conforming implants to reduce contact stress. However, the new generations of more oxidatively-stable polyethylene have improved the long-term mechanical properties of the material, and therefore allowed more flexibility in the bearing design. The purpose of this study was to investigate the effect of insert conformity and material on the wear performance of a fixed bearing total knee replacement through experimental simulation. Methods. The wear of TKR bearings were investigated using a physiological six station Prosim knee wear simulator (Simulator Solutions, UK). Six samples of each test configuration (Sigma CR fixed bearing knees (DePuy Synthes, UK) were studied, and compared with previously reported data, tested under identical conditions (1, 2). The central axis of the implant was offset from the aligned axes of applied load and tibial rotation to replicate a right knee. High kinematics, under anterior-posterior displacement control was used for this study (3). The lubricant was 25% (v/v) calf serum supplemented with 0.03% (v/v) sodium azide solution in deionised water, as an antibacterial agent, and was changed approximately every 0.33Mc. Wear was assessed gravimetrically and moisture uptake accounted for using unloaded soak controls. Results. The wear rates for the moderately cross-linked inserts (XLK) were significantly lower than the conventional polyethylene (GVF) for all geometries (ANOVA, p<0.05). There was a significant reduction in wear rate as the insert geometry became less conforming for both materials (ANOVA, p<0.05). The wear scars areas were comparable in size and shape between materials, within a geometry group. The size of the wear scar changed with conformity, with the curved inserts showing the largest scars in both anterior-posterior and medial-lateral dimensions, and the flat inserts showing the smallest wear scars. Discussion/Conclusion. The introduction of a moderately cross-linked polyethylene insert was shown to significantly reduce the wear of a fixed bearing total knee replacement compared with a conventional material. There was a trend for reducing wear rate with reducing conformity for both materials, suggesting that reduced conformity results in higher contact pressures and reduced contact area, leading to a reduced surface for wear to occur. Both material and conformity were shown to have a significant impact on the wear of a fixed bearing TKR, and therefore provide opportunity for enhancing wear performance through material and design selection

Background. Wear simulation in total knee arthroplasty (TKA) is currently based on the most frequent activity – level walking. A decade ago multi-station knee wear simulators were introduced leading to optimisations of TKA designs, component surface finish and bearing materials. One major limitation is that current wear testing is mainly focused on abrasive-adhesive wear and in vitro testing does not reflect “delamination” as an essential clinical failure mode. The objective of our study was to use a highly demanding daily activities wear simulation to evaluate the delamination risk of polyethylene materials with and without vitamin E stabilisation. Methods. A cruciate retaining fixed bearing TKA design (Columbus CR) with artificially aged polyethylene knee bearings (irradiation 30±2 kGy) blended with and without 0.1% vitamin E was used under medio-lateral load distribution and soft tissue restrain simulation. Daily patient activities with high flexion (2×40% stairs up and down, 10% level walking, 8% chair raising, 2% deep squatting) were applied for 5 million cycles. The specimens were evaluated for gravimetric wear and analysed for abrasive-adhesive and delamination wear modes. Results. The total amount of gliding surface wear was 28.7±1.9 mg for the vitamin E stabilised polyethylene compared to 355.9±119.8 mg for the standard material. The combination of artificial ageing and high demanding knee wear simulation leads to visible signs of delamination in the articulating bearing areas in vitro. Conclusion. To evaluate Vitamin E stabilised polyethylenes in regard to ageing and wear behaviour in vitro, conditions are simulated to create clinical relevant failure modes in the reference material

Hip simulators have been used for ten years to determine the tribological performance of large-head metal-on-metal devices using traditional test conditions. However, the hip simulator protocols were originally developed to test metal-on-polyethylene devices. We have used patient activity data to develop a more physiologically relevant test protocol for metal-on-metal devices. This includes stop/start motion, a more appropriate walking frequency, and alternating kinetic and kinematic profiles.

There has been considerable discussion about the effect of heat treatments on the wear of metal-on-metal cobalt chromium molybdenum (CoCrMo) devices. Clinical studies have shown a higher rate of wear, levels of metal ions and rates of failure for the heat-treated metal compared to the as-cast metal CoCrMo devices. However, hip simulator studies in vitro under traditional testing conditions have thus far not been able to demonstrate a difference between the wear performance of these implants.

Using a physiologically relevant test protocol, we have shown that heat treatment of metal-on-metal CoCrMo devices adversely affects their wear performance and generates significantly higher wear rates and levels of metal ions than in as-cast metal implants.