A prospective multicentric trial on accuracy, efficiency, safety, and outcomes of robot-assisted thoracic pedicle screw fixation.

Pedicle screw fixation is the gold standard for thoracic spine stabilization, but its accuracy is critical due to neurological and vascular complication risks. Robotic-assisted techniques show promise in improving accuracy and reducing radiation, but thoracic-specific evidence is limited. This prospective multicentric observational cohort study involves 6 high-volume centers. 100 adult patients (18-65 years) undergoing robot-assisted thoracic pedicle screw fixation will be recruited. The standardized workflow includes positioning, robotic arm mounting, registration (CT-to-fluoroscopy or scan-and-plan), and screw insertion using powered instrumentation. Data collection will cover preoperative demographics, intraoperative parameters (operative time, radiation exposure, blood loss), and postoperative outcomes. Accuracy will be assessed via the Gertzbein-Robbins grading system on postoperative CT or O-arm scans. Efficiency metrics will cover registration, planning, and screw insertion times. Clinical outcomes (VAS, ODI, SRS-22, patient satisfaction) will be evaluated at 3, 6, and 12 months. This multicentric trial will provide real-world evidence on robot-assisted thoracic pedicle screw fixation. The expectation is to develop a standardized workflow, yielding significantly higher screw placement accuracy than conventional techniques, while achieving comparable clinical outcomes. Knowledge of Robotic pedicle screw fixation utility specific to the thoracic spine is limited. This study contributes by evaluating and comparing the two registration techniques (CT-to-Fluoroscopy and Scan-and-Plan), and assessing the accuracy, safety, efficiency, and clinical outcomes of robot-assisted thoracic pedicle screw placement.