Validation of a Novel Device for the Knee Monitoring of Orthopaedic Patients.

Fast-track surgery is becoming increasingly popular, whereas the monitoring of postoperative rehabilitation remains a matter of considerable debate. The aim of this study was to validate a newly developed wearable system intended to monitor knee function and mobility. A sensor system with a nine-degree-of-freedom (DOF) inertial measurement unit (IMU) was developed. Thirteen healthy volunteers performed five 10-meter walking trials with simultaneous sensor and motion capture data collection. The obtained kinematic waveforms were analysed using root mean square error (RMSE) and correlation coefficient (CC) calculations. The Bland-Altman method was used for the agreement of discrete parameters consisting of peak knee angles between systems. To test the reliability, 10 other subjects with sensors walked a track of 10 metres on two consecutive days. The Pearson CC was excellent for the walking data set between both systems (r = 0.96) and very good (r = 0.95) within the sensor system. The RMSE during walking was 5.17° between systems and 6.82° within sensor measurements. No significant differences were detected between the mean values observed, except for the extension angle during the stance phase (E1). Similar results were obtained for the repeatability test. Intra-class correlation coefficients (ICCs) between systems were excellent for the flexion angle during the swing phase (F1); good for the flexion angle during the stance phase (F2) and the re-extension angle, which was calculated by subtracting the extension angle at swing phase (E2) from F2; and moderate for the extension angle during the stance phase (E1), E2 and the range of motion (ROM). ICCs within the sensor measurements were good for the ROM, F2 and re-extension, and moderate for F1, E1 and E2. The study shows that the novel sensor system can record sagittal knee kinematics during walking in healthy subjects comparable to those of a motion capture system.