Abstract
BACKGROUND: Soft tissue balancing is essential for the success of total knee arthroplasty (TKA) and is mainly dependent on surgeon-defined assessment (SDA) or a gap-balancer (GB). However, an electronic sensor has been developed to objectively measure the gap pressure. This study aimed to evaluate the accuracy of soft tissue balancing using SDA and GB compared with a sensor. METHODS: Forty-eight patients undergoing TKA (60 knees) were prospectively enrolled. Soft tissue balancing was sequentially performed using SDA, a GB, and an electronic sensor. We compared the SDA, GB, and sensor data to calculate the sensitivity, specificity, and accuracy at 0°, 45°, 90°, and 120° flexion. Cumulative summation (CUSUM) analysis was performed to assess the surgeon's performance during the sensor introductory phase. RESULTS: The sensitivity of SDA was 63.3%, 68.3%, 80.0%, and 80.0% at 0°, 45°, 90°, and 120°, respectively. The accuracy of the GB compared with sensor data was 76.7% and 71.7% at 0° and 90°, respectively. Cohen's kappa coefficient for the accuracy of the GB was 0.406 at 0° (moderate agreement) and 0.227 at 90° (fair agreement). The CUSUM 0° line achieved good prior performance at case 45, CUSUM 90° and 120° showed a trend toward good prior performance, while CUSUM 45° reached poor prior performance at case 8. CONCLUSION: SDA was a poor predictor of knee balance. GB improved the accuracy of soft tissue balancing, but was still less accurate than the sensor, particularly for unbalanced knees. SDA improved with ongoing use of the sensor, except at 45° flexion.