Femoral prosthesis alignment of augmented reality-assisted versus accelerometer-based navigation in total knee arthroplasty: A noninferiority analysis

The purpose of this study was to examine the comparative precision of the augmented reality (AR)-assisted navigation system and the accelerometer-based navigation system in total knee arthroplasty (TKA). We performed noninferiority analysis in a retrospective cohort. The coronal alignment of femoral prosthesis was compared between 109 TKAs performed using the AR-assisted navigation system and 118 TKAs performed using the accelerometer-based navigation system. All femoral prostheses were planned to be positioned perpendicular to the mechanical axis of the femur. The primary outcome was the success rate of coronal alignment of the femoral prosthesis defined as alignment error relative to neutral alignment <3°. We calculated the noninferiority margin as 7%-points using the 95%–95 % method and also confirmed the validity of the noninferiority margin using the fixed margin method. Noninferiority would be shown if the lower boundary of the 95 % confidence interval (CI) for the between-group difference in percentage of the success rate was not less than 0.93 (i.e., 1.00 − 0.07). Treatment success was achieved in 104 of 109 patients (95.4 %) in the AR-assisted navigation group and 110 of 118 (93.2 %) in the accelerometer-based navigation group. The risk ratio of success between the AR-assisted navigation group versus accelerometer-based navigation group was 1.02 (95 % CI, 0.96 to 1.09): the CIs did not include the noninferiority margin of 0.93. The AR-assisted navigation system was noninferior to the accelerometer-based navigation system in terms of coronal alignment of the femoral prosthesis in TKA.