Loading and kinematic profiles for patellofemoral durability testing.

Patellar complications after total knee replacement (TKR), such as maltracking, fracture, wear, and loosening, can lead to implant failure and revision surgery. However, few in vitro patellofemoral durability tests for the implanted joint have been developed. Existing standards for patellofemoral loading profiles (ISO 14243-5, draft) are generic (not implant-specific) and do not include patient variability. The goal of this study was to derive implant-specific loading profiles to simulate a motor task that reaches high knee flexion and include patient variability. In vivo data, including motion capture and stereo-radiographic images at the knee, were collected for eleven rotating platform TKR patients performing a single-leg lunge activity. Quadriceps forces during the activity were estimated for each patient from marker data and ground forces with a musculoskeletal model. Patellofemoral contact forces were estimated with patient-specific finite element models of the implanted knees. Stereo-radiography patellofemoral kinematics and estimated contact loads were combined to derive seven loading profiles that span the observed inter-patient variability. The loading profiles were experimentally evaluated in a 6-degree-of-freedom testing machine and worst-case loading profiles were identified. The two profiles that generated the highest stresses in the patellar button (43% and 46% of the volume surpassed yield stress, respectively) included the largest internal (4.4°) and external (13.0°) patellar rotation, and greater medio/lateral contact forces (up to 915 N). The same profiles were also tested in a finite element model of the experimental simulator, which was able to adequately replicate location and magnitude of the peak deformations measured in the prostheses after the experiment. The kinematic and loading profiles developed in this study simulated a high-demand motor task and incorporated inter-patient variability, capturing worst-case patellofemoral configurations, and can be utilized for pre-clinical testing of new patellar designs.