Design and evaluation of instrumented smart knee implant.

The goal of ligament balancing in total knee arthroplasty (TKA) is to distribute the tibiofemoral compressive forces symmetrically between the medial and lateral compartments of a well-aligned prosthetic knee, as well as to reestablish a rectangular and identical tibiofemoral gap in both flexion and extension. Nowadays, the proper alignment of knee mechanical axis and the perfect equalization of flexion and extension gaps are ensured by computer-assisted TKA (CATKA). Nevertheless, any residual imbalance of collateral ligaments at the time of surgery can lead to an excessive imbalance in the postoperative period during the weight-bearing activities, which subject the knee collateral ligaments to increased loading. This in turn leads to an accelerated polyethylene wear, and consequently, to early failure of TKA. The instrumented tibial implant proposed in this study can postoperatively assess and monitor the progression of residual postoperative ligament imbalance of a prosthetic knee, which is perfectly aligned during the surgery thanks to CATKA, via a center-of-pressure (COP)-based approach. This approach depends on the measurement of relative displacement of COP position during the postoperative period with respect to a reference position recorded at the beginning of this period. This measurement is performed for six predetermined flexion angles representative of an entire gait cycle. The tibial implant can also generate the electrical power in addition to their role in monitoring the COP position thanks to the piezoceramics embedded within the tibial tray to achieve this twofold task. Experimental and finite-element analysis (FEA) studies have been conducted to validate the methodology used for the postoperative assessment of residual knee laxity. The issues concerning electrical energy generation and data transmission will be thoroughly discussed in another paper.