Abstract
OBJECTIVE: The pedicle screw insertion technique has evolved significantly, and despite the challenges of precise placement, advancements like AR-based surgical navigation systems now offer enhanced accuracy and safety in spinal surgery by integrating real-time, high-resolution imaging with virtual models to aid surgeons. This study aims to evaluate the differences in accuracy between novel AR-guided pedicle screw insertion and conventional surgery techniques. METHODS: A randomized controlled trial was conducted from March 2019 to December 2023 to compare the efficacy of AR-guided pedicle screw fixation with conventional freehand surgery using CT guidance. The study included 150 patients, aged 18-75, with 75 patients in each group. The total number of pedicle screws planned for the clinical trial placement was 351 and 348 in the experimental and control groups. The safety and efficacy of the procedures were evaluated by assessing screw placement accuracy and complication rates. RESULTS: In the full analysis set (FAS) analysis, the difference in the excellent and good rates of screw placement (experimental group - control group) and 95% confidence interval was 6.3% [3.0%-9.8%], with a p value of 0.0003 for the superiority test. In the FAS sensitivity analysis, the success rate was 98.0% (344 out of 351) in the experimental group and 91.7% (319 out of 348) in the control group, with a difference and 95% confidence interval of 6.3% [2.9% and 9.8%, respectively]. In the per-protocol set (PPS) analysis, the difference in the excellent and good rates of screw placement between the experimental and control groups, and the 95% confidence interval was 6.4% [3.3%-9.5%], with a p value of 0.0001 for the superiority test. In the actual treatment set (ATS) analysis, the excellent and good rates of screw placement were 99.1% in the experimental group and 91.7% in the control group. The difference in the excellent and good rates of screw placement (experimental group - control group) and 95% confidence interval was 7.3% [4.1%-10.6%], with a p value of < 0.0001 for the superiority test. CONCLUSIONS: The AR surgical navigation system can improve the accuracy of pedicle screw implantation and provide precise guidance for surgeons during pedicle screw insertion.