The Pivot-shift phenomenon (PS) is known to be one of the essential signs of functional insufficiency of the anterior cruciate ligament (ACL). To evaluate the dynamic knee laxity is very important to accurately diagnose ACL injury, to assess surgical reconstructive techniques, and to evaluate treatment approaches. However, the pivot-shift test remains a subjective clinical examination difficult to quantify. The aim of the present study is to validate the use of an innovative non-invasive device based on the use of an inertial sensor to quantify PS test. The validation was based on comparison with data acquired by a surgical navigation system.

The surgeon intraoperatively performed the PS tests on 15 patients just before fixing the graft required for the ACL reconstruction. A single accelerometer and a navigation system simultaneously acquired the joint kinematics. An additional optical tracker set to the accelerometer has allowed to quantify the movement of the sensor. The tibial anteroposterior acceleration obtained with the navigation system was compared with the acceleration acquired by the accelerometer. It is therefore estimated the presence of any artifacts due to the soft tissue as the test-retest repositioning error in the positioning of the sensor. It was also examined, the repeatability of the acceleration parameters necessary for the diagnosis of a possible ACL lesion and the waveform of the output signal obtained during the test. Finally it has been evaluated the correlation between the two acceleration measurements obtained by the two sensors.

The RMS (root mean square) of the error of test-retest positioning has reported a good value of 5.5 ± 2.9 mm. While the amounts related to the presence of soft tissue artifacts was equal to 4.9 ± 2.6 mm. It was also given a good intra-tester repeatability (Cronbach's alpha = 0.86). The inter-patient similarity analysis showed a high correlation in the acceleration waveform of 0.88 ± 0.14. Finally the measurements obtained between the two systems showed a good correlation (rs = 0.72, p<0.05).

This study showed good reliability of the proposed scheme and a good correlation with the results of the navigation system. The proposed device is therefore to be considered a valid method for evaluating dynamic joint laxity.