Loading clinical trials...
Loading clinical trials...
ROBOTICSS - Robotic-Assisted Pedicle Screw Placement in Spine Surgery: A Multicenter Prospective Observational Study
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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Sahlgrenska university hospital
Gothenburg, Sweden
Ryhov hospital
Jönköping, Sweden
Länssjukhuset Kalmar
Kalmar, Sweden
University Hospital Linköping
Linköping, Sweden
Örebro University Hospital
Örebro, Sweden
Karolinska University Hospital
Stockholm, Sweden
South General Hospital (Södersjukhuset)
Stockholm, Sweden
Umeå University Hospital
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Start Date
February 2, 2026
Primary Completion Date
February 2, 2032
Completion Date
February 2, 2035
Last Updated
March 10, 2026
7,200
ESTIMATED participants
Robotic-assisted pedicle screw placement
DEVICE
Lead Sponsor
Uppsala University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions