Comparison of intraoperative cone-beam CT versus preoperative fan-beam CT for navigated spine surgery: a prospective randomized study.

OBJECTIVE: This prospective randomized study aimed to investigate the accuracy, radiation exposure, and surgical workflow optimization of a novel intraoperative spinal navigation system using preoperative fan-beam (FB) CT versus the classic intraoperative cone-beam (CB) CT in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). METHODS: In this two-arm, single-center, randomized study, the authors evaluated the safety and clinical outcomes of a novel navigation system for pedicle screw placement in spine surgery. RESULTS: The accuracy of pedicle screw placement in the experimental group (FB group) was 94.38%, while it was 94.55% in the control group (CB group). Notably, the intraoperative radiation exposure to patients in the FB CT group (mean 0.361 ± 0.261 mSv) was significantly lower than that in the CB CT group (mean 6.526 ± 13.591 mSv) (p < 0.0001). Furthermore, the intraoperative preparation time for screw placement in the FB group (mean 10.6 ± 5.62 minutes) was significantly lower than that in the CB group (mean 17.6 ± 5.59 minutes) (p = 0.0004). No significant differences were observed for blood loss during surgery, total radiation exposure to surgeons, mean time for inserting a single pedicle screw, revision surgery rate, patients' reported outcomes, and length of postoperative hospital stay between the two groups. Significant differences were observed for intraoperative radiation exposure to patients and the preparation time for pedicle screw placement. CONCLUSIONS: The preoperative FB CT-based intraoperative spinal navigation system demonstrated comparable accuracy and safety when compared with the intraoperative CB CT-based system. Moreover, the FB CT-based system had a shorter time for screw placement and reduced intraoperative radiation exposure to patients. These findings support the potential benefits of adopting this novel navigation system to enhance surgical precision and reduce radiation-related risks in MIS-TLIF procedures.