Objectives: Augmented reality (AR) navigation systems are emerging to simplify and enhance the precision of medical procedures. Lumbosacral transforaminal epidural injection is a commonly performed procedure for the treatment and diagnosis of radiculopathy. Accurate needle placement while avoiding critical structures remains a challenge. For this purpose, we conducted a randomized controlled trial for our augmented reality navigation system. Methods: This randomized controlled study involved 28 patients, split between a traditional C-arm guided group (control) and an AR navigation guided group (AR-NAVI), to compare procedure efficiency and radiation exposure. The AR-NAVI group used a real-time tracking system displaying spinal structure and needle position on an AR head-mounted display. The procedural time and C-arm usage (radiation exposure) were measured. Results: All patients underwent successful procedures without complications. The AR-NAVI group demonstrated significantly reduced times and C-arm usage for needle entry to the target point (58.57 ± 33.31 vs. 124.91 ± 41.14, p < 0.001 and 3.79 ± 1.97 vs. 8.86 ± 3.94, p < 0.001). Conclusions: The use of the AR navigation system significantly improved procedure efficiency and safety by reducing time and radiation exposure, suggesting a promising direction for future enhancements and validation.
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