BACKGROUND: Portable hip navigation systems have been developed to combine the accuracy of cup positioning by large console navigation systems with the ease of use and convenience of conventional surgical techniques. Although a novel augmented reality-based portable hip navigation system using a smartphone (AR navigation) has become available recently, no studies, to our knowledge, have compared commercially available AR navigation with the conventional technique. Additionally, no studies, except for those from designer-surgeon series, have demonstrated the results of AR navigation.
QUESTIONS/PURPOSES: (1) Does intraoperative use of commercially available AR navigation improve cup positioning compared with the conventional technique? (2) Are operative factors, clinical scores, and postoperative course different between the two groups?
METHODS: In this randomized trial, 72 patients undergoing THA were randomly assigned to undergo either commercially available AR navigation or a conventional technique for cup placement. All patients received the same cementless acetabular cups through a posterior approach in the lateral decubitus position. The primary outcome of the present study was cup positioning, including the absolute differences between the intended target and angle achieved, as well as the number of cups inside the Lewinnek safe zone. Our target cup position was 40° abduction and 20° anteversion. Secondary outcomes were operative factors, between-group difference in improvement in the Hip Disability and Osteoarthritis Outcome Score (HOOS), and the postoperative course, including the operative time (between the start of the surgical approach and skin closure), procedure time (between the first incision and skin closure, including the time to insert pins, registration, and transfer and redrape patients in the navigation group), time taken to insert pins and complete registration in the navigation group, intraoperative and postoperative complications, and reoperations. The minimum follow-up period was 6 months, because data regarding the primary outcome-cup positioning-were collected within 1 week after surgery. The between-group difference in improvement in HOOS, which was the secondary outcome, was much lower than the minimum clinically important difference for the HOOS. No patients in either group were lost to follow-up, and there was no crossover (the randomized treatment was performed in all patients, so there was no difference between an intention-to-treat and a per-protocol analysis).
RESULTS: The use of the commercially available AR navigation slightly improved cup positioning compared with the conventional technique in terms of the absolute difference between the desired and achieved amounts of cup abduction and anteversion (which we defined as "absolute differences"; median 1° [IQR 0° to 4.0°] versus median 5° [IQR 3.0° to 7.5°], difference of medians 4°; p < 0.001 and median 2° [IQR 1.9° to 3.7°] versus median 5° [IQR 3.2° to 9.7°], difference of medians 2°; p = 0.001). A higher proportion of cups were placed inside the Lewinnek safe zone in the navigation group than in the control group (94% [34 of 36] compared with 64% [23 of 36]; p < 0.001). Median operative times were not different between the two groups (58 minutes [IQR 49 to 72 minutes] versus 57 minutes [IQR 49 to 69 minutes], difference of medians 1 minute; p = 0.99). The median procedure time was longer in the navigation group (95 minutes [IQR 84 to 109 minutes] versus 57 minutes [IQR 49 to 69 minutes], difference of medians 38 minutes; p < 0.001). There were no differences between the two groups in improvement in HOOS (27 ± 17 versus 28 ± 19, mean difference -1 [95% CI -9.5 to 7.4]; p = 0.81). In the navigation group, no complications occurred in the pin sites; however, one anterior dislocation occurred. In the conventional group, one hip underwent reoperation because of a deep infection.
CONCLUSION: Although the use of commercially available AR navigation improved cup positioning in THA, the improvement in clinical scores and postoperative complication rates were not different between the two groups, and the overall magnitude of the difference in accuracy was small. Future studies will need to determine whether the improvement in the percentage of hips inside the Lewinnek safe zone results in differences in late dislocation or polyethylene wear, and whether such benefits-if any-justify the added costs and surgical time. Until or unless more compelling evidence in favor of the new system emerges, we recommend against widespread use of the system in clinical practice.
LEVEL OF EVIDENCE: Level Ⅱ, therapeutic study.