NCT07461636

Robotic-Assisted Pedicle Screw Placement in Spine Surgery

ROBOTICSS - Robotic-Assisted Pedicle Screw Placement in Spine Surgery: A Multicenter Prospective Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 7,200 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This prospective multicenter observational cohort study evaluates robotic-assisted pedicle screw placement compared with non-robotic-assisted techniques in spinal surgery. Primary objectives include screw placement accuracy, operative learning curve, and reoperation rate within 2 years.

Detailed description

Pedicle screw fixation is widely used in spinal surgery. Screw misplacement may cause complications and reoperations. Robotic-assisted systems aim to improve accuracy and workflow; however, high-quality real-world evidence regarding long-term clinical outcomes and cost-effectiveness remains limited. This nationwide cohort study includes consecutive patients undergoing spinal surgery with pedicle screws. Exposure is robotic-assisted versus non-robotic-assisted (navigation-assisted or freehand) screw placement. Data capture is made from registries, radiographs and hospital data. Follow-up is up to 2 years for the primary outcomes and up to 5 years for the secondary outcomes.

Conditions

• Pedicle Screw Fixation of Spine

Interventions

Type	Name	Description
DEVICE	Robotic-assisted pedicle screw placement	Robotic-assisted pedicle screw placement using commercially available robotic systems

Timeline

• Start date: 2026-02-02
• Primary completion: 2032-02-02
• Completion: 2035-02-02
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

9 sites across 1 country: Sweden