CLINICAL VALIDATION OF A NOVEL SPRING LOADED TENSIONING DEVICE AND COMPUTER ASSISTED NAVIGATION
This study presents the validation of the tensioning device that applies a constant load to the medial and lateral compartments of knee joint separately, which can collapse or expand on each side independently, and that should be able to provide a better evaluation of ligament tension and allow the computer software to better plan the appropriate bone cuts or ligament release, and reports the first phase of the clinical validation of the tensioning device, including first qualitative comparison with standard navigated technique and consideration on the use of the device. A randomized study, involving five experienced orthopedic surgeons with 58 complete data sets, revealed that there is no statistical difference between the gaps obtained with standard navigated technique and tensioning device in extension, while in flexion there is an average difference 1.4 mm.