Robotic-assisted pedicle screw placement for spine surgery
ROBOTICSS - Robotic-Assisted Pedicle Screw Placement in Spine Surgery: A Multicenter Prospective Observational Study
This project will test whether using robotic systems to place pedicle screws in spine surgery improves screw accuracy, lowers reoperation rates, and changes the learning curve for patients of all ages who need pedicle-screw fixation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7200 (estimated) |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Locations | 9 sites (Gothenburg and 8 other locations) |
| Trial ID | NCT07461636 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational cohort comparing robotic-assisted pedicle screw placement with non-robotic techniques (navigation-assisted or freehand) across consecutive patients. Data are collected from hospital records, registries, and radiographs to capture technical accuracy, operative metrics, and clinical outcomes. The primary outcomes are screw placement accuracy, the operative learning curve, and reoperation rate within two years, with additional secondary outcomes followed up to five years. The cohort includes patients of all ages and spinal diagnoses treated at participating Swedish centers.
Who should consider this trial
Good fit: Patients of any age undergoing spine surgery that will include pedicle-screw fixation in the cervical, thoracic, lumbar spine, or sacrum are the intended participants.
Not a fit: Patients who are not receiving pedicle screws (for example, decompression-only procedures) or whose surgery is performed outside participating centers will not be included and are unlikely to benefit directly.
Why it matters
Potential benefit: If successful, robotic-assisted placement could improve screw accuracy, reduce complications and reoperations, and make procedures more efficient.
How similar studies have performed: Prior device and observational studies have often shown improved placement accuracy with robotic or navigation assistance, but robust long-term comparative outcome and cost-effectiveness evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Treatment with pedicle screws in the cervical, thoracic, lumbar spine and/or sacrum. * All ages and spinal diagnoses Exclusion Criteria: * Treatment without pedicle screws
Where this trial is running
Gothenburg and 8 other locations
- Sahlgrenska university hospital — Gothenburg, Sweden (Recruiting)
- Ryhov hospital — Jönköping, Sweden (Recruiting)
- Länssjukhuset Kalmar — Kalmar, Sweden (Recruiting)
- University Hospital Linköping — Linköping, Sweden (Recruiting)
- Örebro University Hospital — Örebro, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- South General Hospital (Södersjukhuset) — Stockholm, Sweden (Recruiting)
- Umeå University Hospital — Umeå, Sweden (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Study coordinator: Paul Gerdhem, MD, PhD
- Email: paul.gerdhem@uu.se
- Phone: +46(0)186110000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.