Development and clinical validation of an unobtrusive ambulatory knee function monitoring system with inertial 9DoF sensors.

Patients suffering from end-stage knee osteoarthritis are often treated with total knee arthroplasty, improving their functional mobility. A number of patients, however, report continued difficulty with stair ascent and descent or sportive activity after surgery and are not completely satisfied with the outcome. State-of-the-art analyses to evaluate the outcome and mobility after knee replacement are conducted under supervised settings in specialized gait labs and thus can only reflect a short period of time. A number of external factors may lead to artificial gait patterns in patients. Moreover, clinically relevant situations are difficult to simulate in a stationary gait lab. In contrast to this, inertial sensors may be used additionally for unobtrusive gait monitoring. However, recent notable approaches found in literature concerning knee function analysis have so far not been applied in a clinical context and have therefore not yet been validated in a clinical setting. The aim of this paper is to present a system for unsupervised long-term monitoring of human gait with a focus on knee joint function, which is applicable in patients' everyday lives and to report on the validation of this system gathered during walking with reference to state-of-the-art gait lab data using a vision system (VICON Motion System). The system KINEMATICWEAR - developed in close collaboration of computer scientists and physicians performing knee arthroplasty - consists of two sensor nodes with combined tri-axial accelerometer, gyroscope and magnetometer to be worn under normal trousers. Reliability of the system is shown in the results. An overall correlation of 0.99 (with an overall RMSE of 2.72) compared to the state-of-the-art reference system indicates a sound quality and a high degree of correspondence. KINEMATICWEAR enables ambulatory, unconstrained measurements of knee function outside a supervised lab inspection.