Augmented Reality Navigation System Enhances the Accuracy of Spinal Surgery Pedicle Screw Placement: A Randomized, Multicenter, Parallel-Controlled Clinical Trial.

研究概要

One hundred fifty patients undergoing thoracolumbar spinal fusion were randomized to receive pedicle screw insertion with an AR (Augmented Reality) guided navigation system (n=75) or conventional CT-guided freehand insertion (n=75). The primary outcome was the excellent placement rate of pedicle screws. Secondary outcomes included facet joint surface penetration, intraoperative screw placement time, number of fluoroscopies, overall surgical duration, blood loss, and adverse events. Outcomes were assessed up to 2 months postoperatively. Overall, the results revealed a significantly higher excellent placement rate in the AR group (98.0%) compared to the control group. The AR group also showed reduced fluoroscopy usage and shorter screw placement times, with a similar safety profile. These findings suggest that AR-guided navigation improves pedicle screw placement accuracy and surgical workflow.