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NCT06153511
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
NA trial testing Robot assisted spinal transpedicular fixation in SPINAL Fracture in 13 participants. Completed in 7 July 2023.
24 April 2023
Quick facts
| Lead sponsor | Cyber Surgery S.L. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 13 |
| Start date | 16 November 2022 |
| Primary completion | 24 April 2023 |
| Estimated completion | 7 July 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Robot assisted spinal transpedicular fixation
Conditions studied
- SPINAL Fracture — all drugs for SPINAL Fracture →
- Vertebral Fractures — all drugs for Vertebral Fractures →
- Spinal Stenosis — all drugs for Spinal Stenosis →
- Kyphosis — all drugs for Kyphosis →
Sponsor
Cyber Surgery S.L.
Who can join
Adults 18 to 85, any sex, with SPINAL Fracture or Vertebral Fractures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients requiring transpedicular screw fixation. The study, conducted in two different hospital centers, involves patients with vertebral fractures, spinal stenosis, kyphosis, and other related conditions. The primary objective is to determine screw accuracy by assessing the degree of screw invasion into the pedicle using the Gertzbein-Robbins scale, with a target of achieving 96% acceptable screw placement. Trained radiologists will evaluate the screw invasion into the pedicle. The study is scheduled to span 12 months and each intervention includes a 1-month follow-up. Throughout this time frame, patients will undergo regular assessments, and outcomes will be closely monitored.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06153511
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for SPINAL Fracture
Currently open trials in the same condition.
- NCT03253952 — A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury. · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06153511 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cyber Surgery S.L.
- Last refreshed: 1 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06153511.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing