Design of a free-floating polycarbonate-urethane meniscal implant using finite element modeling and experimental validation.

The development of a synthetic meniscal implant that does not require surgical attachment but still provides the biomechanical function necessary for joint preservation would have important advantages. We present a computational-experimental approach for the design optimization of a free-floating polycarbonate-urethane (PCU) meniscal implant. Validated 3D finite element (FE) models of the knee and PCU-based implant were analyzed under physiological loads. The model was validated by comparing calculated pressures, determined from FE analysis to tibial plateau contact pressures measured in a cadaveric knee in vitro. Several models of the implant, some including embedded reinforcement fibers, were tested. An optimal implant configuration was then selected based on the ability to restore pressure distribution in the knee, manufacturability, and long-term safety. The optimal implant design entailed a PCU meniscus embedded with circumferential reinforcement made of polyethylene fibers. This selected design can be manufactured in various sizes, without risking its integrity under joint loads. Importantly, it produces an optimal pressure distribution, similar in shape and values to that of natural meniscus. We have shown that a fiber-reinforced, free-floating PCU meniscal implant can redistribute joint loads in a similar pattern to natural meniscus, without risking the integrity of the implant materials.