Trials / Active Not Recruiting
Active Not RecruitingNCT05082090
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- Orthofix Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This protocol is designed to study Orthofix regulatory approved and commercially available spine devices to generate Real World Evidence (RWE) of device safety and performance in the treatment of patients with spine injuries and/or disorders following the local medical standard of care. The clinical data generated from this study will support compliance to global regulatory requirements including but not limited to the European Medical Device Regulation (EU MDR) for the applicable devices.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Spinal Surgery | Implanted with Orthofix Spinal products |
Timeline
- Start date
- 2021-09-15
- Primary completion
- 2031-12-01
- Completion
- 2031-12-01
- First posted
- 2021-10-18
- Last updated
- 2025-07-30
Locations
20 sites across 4 countries: United States, Germany, South Africa, Spain
Source: ClinicalTrials.gov record NCT05082090. Inclusion in this directory is not an endorsement.