Design, calibration and pre-clinical testing of an instrumented tibial tray.

An instrumented tibial tray was developed that enables the measurement of six load components in a total knee arthroplasty (TKA). The design is fully compatible with a commonly available knee arthroplasty product since it uses the original tibial insert and femoral component. Two plates with hollow stems made from titanium alloy are separated by a small gap. Six semiconductor strain gages are used for measuring the load-dependent deformation of the inner hollow stem. A 9-channel telemetry unit with a radio-frequency transmitter is encapsulated hermetically in the cavity of the prosthesis. The telemetry is powered inductively and strain gage signals are transmitted via a small antenna at the tip of the implant. The mean sampling rate is 125Hz. The calibration of the prosthesis resulted in an accuracy better than 2% mean measuring error. Fatigue testing of the implant was performed up to 10 million loading cycles and showed no failure. The pending in vivo application will give further insight into the kinetics of TKA. The measured values will enhance the quality of future pre-clinical testing, numerical modeling in knee biomechanics and the patients' physiotherapy and rehabilitation.