Prospective Comparison Study Between the Fluoroscopy-guided and Navigation Coupled With O-arm-guided Pedicle Screw Placement in the Thoracic and Lumbosacral Spines.

Study Design: This is a prospective randomized comparison study between the fluoroscopy-guided and navigation coupled with O-arm-guided pedicle screw placement in the thoracic and lumbosacral spines.

Objective: The objective of the study was to evaluate the accuracy and clinical benefits of a navigation coupled with O-arm-guided method in the thoracic and lumbar spines by comparing with a C-arm fluoroscopy-guided method.

Methods: Under fluoroscopy guidance, 138 pedicle screws were inserted from T9 to S1 in 20 patients, and 124 pedicle screws were inserted from T9 to S1 in 20 patients using the navigation. The position of the screws within the pedicle was assessed from grade 0 (no violation cortex) to grade 3 (>4 mm violation), and the location of the violated cortex was determined. Preparation time of each equipment setting, time for screwing, and the number of x-ray shots were evaluated.

Results: The number of screws observed as grade 0 was 121 (87.7%) in the fluoroscopy-guided group and 114 (91.9%) in the navigation-guided group. The lateral cortex was most commonly involved in the fluoroscopy-guided group (6 cases, 35.3%), and the medial cortex was most common in the navigation-guided group (4 cases, 40%). The mean time required for preparation for screw placement was 3.7 minutes in the fluoroscopy-guided group and 14.2 minutes in the navigation-guided group. Average screwing time was 3.6 minutes in the fluoroscopy-guided group and 4.3 minutes in the navigation-guided group. The mean number of x-ray shots for each screw placement in the fluoroscopy-guided group was 6.5. Postoperatively, 2 patients with misplacement of a screw under fluoroscopy guidance presented ipsilateral leg paresthesia, possibly related to the screw position.

Conclusions: The present prospective study reveals that the pedicle screw placement guided by the navigation coupled with O-arm system was more accurate and safer than that under fluoroscopy guidance.