Abstract
BACKGROUND: Robotic spinal surgery may result in better pedicle screw placement accuracy, and reduction in radiation exposure and length of stay, compared to freehand surgery. The purpose of this randomized controlled trial (RCT) is to compare screw placement accuracy of robot-assisted surgery with integrated 3D computer-assisted navigation versus freehand surgery with 2D fluoroscopy for arthrodesis of the thoraco-lumbar spine. METHODS: This is a single-centre evaluator-blinded RCT with a 1:1 allocation ratio. Participants (n = 300) will be randomized into two groups, robot-assisted (Mazor X Stealth Edition) versus freehand, after stratification based on the planned number of pedicle screws needed for surgery. The primary outcome is the proportion of pedicle screws placed with grade A accuracy (Gertzbein-Robbins classification) on postoperative computed tomography images. The secondary outcomes are intervention time, operation room occupancy time, length of stay, estimated blood loss, surgeon's radiation exposure, screw fracture/loosening, superior-level facet joint violation, complication rate, reoperation rate on the same level or one level above, functional and clinical outcomes (Oswestry Disability Index, pain, Hospital Anxiety and Depression Scale, sensory and motor status) and cost-utility analysis. DISCUSSION: This RCT will provide insight into whether robot-assisted surgery with the newest generation spinal robot yields better pedicle screw placement accuracy than freehand surgery. Potential benefits of robot-assisted surgery include lower complication and revision rates, shorter length of stay, lower radiation exposure and reduction of economic cost of the overall care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05553028. Registered on September 23, 2022.