Abstract
BACKGROUND: Previous studies reported good outcomes of acetabular cup placement using portable navigation systems during THA. However, we are aware of no prospective studies comparing inexpensive portable navigation systems using augmented reality (AR) technology with accelerometer-based portable navigation systems in THA. QUESTIONS/PURPOSES: (1) Is the placement accuracy of the acetabular cup using the AR-based portable navigation system superior to that of an accelerometer-based portable navigation system? (2) Do the frequencies of surgical complications differ between the two groups? METHODS: We conducted a prospective, two-arm, parallel-group, randomized controlled trial involving patients scheduled for unilateral THA. Between August and December 2021, we treated 148 patients who had a diagnosis of osteoarthritis, idiopathic osteonecrosis, rheumatoid arthritis, or femoral neck fracture and were scheduled to undergo unilateral primary THA. Of these patients, 100% (148) were eligible, 90% (133) were approached for inclusion in the study, and 85% (126) were finally randomized into either the AR group (62 patients) or the accelerometer group (64 patients). An intention-to-treat analysis was performed, and there was no crossover between groups and no dropouts; all patients in both groups were included in the analysis. There were no differences in any key covariates, including age, sex, and BMI, between the two groups. All THAs were performed via the modified Watson-Jones approach with the patient in the lateral decubitus position. The primary outcome was the absolute difference between the cup placement angle displayed on the screen of the navigation system and that measured on postoperative radiographs. The secondary outcome was intraoperative or postoperative complications recorded during the study period for the two portable navigation systems. RESULTS: There were no differences between the AR and accelerometer groups in terms of the mean absolute difference in radiographic inclination angle (3° ± 2° versus 3° ± 2° [95% CI -1.2° to 0.3°]; p = 0.22). The mean absolute difference in radiographic anteversion angle displayed on the navigation screen during surgery compared with that measured on postoperative radiographs was smaller in the AR group than that in the accelerometer group (2° ± 2° versus 5° ± 4° [95% CI -4.2° to -2.0°]; p < 0.001). There were few complications in either group. In the AR group, there was one patient each with a surgical site infection, intraoperative fracture, distal deep vein thrombosis, and intraoperative pin loosening; in the accelerometer group, there was one patient each with an intraoperative fracture and intraoperative loosening of pins. CONCLUSION: Although the AR-based portable navigation system demonstrated slight improvements in radiographic anteversion of cup placement compared with the accelerometer-based portable navigation system in THA, whether those small differences will prove clinically important is unknown. Until or unless future studies demonstrate clinical advantages that patients can perceive that are associated with such small radiographic differences, because of the costs and the unquantified risks associated with novel devices, we recommend against the widespread use of these systems in clinical practice. LEVEL OF EVIDENCE: Level I, therapeutic study.