Robotic-assisted pedicle screw placement for spine surgery
Official title: ROBOTICSS - Robotic-Assisted Pedicle Screw Placement in Spine Surgery: A Multicenter Prospective Observational Study
Run by Uppsala University · NCT07461636 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 7200 (estimated) |
| Sponsor | Uppsala University Academic / other |
| Locations | 9 sites (Gothenburg and 8 other locations) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | February 2, 2032 |
| Study ends | February 2, 2035 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07461636 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 3 more locations
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.