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NCT06020417: NoHARM
Pedicle Screw Malposition in Spine Arthrodesis Surgeries With O-ARM-guided Navigation
NA trial testing O-ARM (Medtronic, Inc, Louisville, CO) in Spinal Fusion in 124 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | Federal University of Piaui |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 124 |
| Start date | 1 August 2024 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- O-ARM (Medtronic, Inc, Louisville, CO)
- Conventional corrective surgery for arthrodesis
Conditions studied
- Spinal Fusion — all drugs for Spinal Fusion →
- Spinal Deformity — all drugs for Spinal Deformity →
- Spine Injury — all drugs for Spine Injury →
Sponsor
Federal University of Piaui
Who can join
18 and older, any sex, with Spinal Fusion or Spinal Deformity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Throughout the history of spinal deformity there have been continuous advances in the surgical treatment. Although many techniques have been successfully developed despite the anatomy complex, screw placement still remains difficult with a significant risk of misplaced implants. The O-ARM guided Navigation is a scanner that allows imaging of screws intraoperatively and could be a tool to facilitate screw revision and reduce the occurrence of misplaced implants. Methods: This is a prospective and randomized clinical study that will be carried out at the University Hospital of the Federal University of Piaui, which provides exclusive assistance to patients of the Unified Health System (UHS), in northeastern Brazil.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06020417
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT06020417 (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 Federal University of Piaui
- Last refreshed: 25 September 2024
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/NCT06020417.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing