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NCT05082090 · ClinicalTrials.gov registry record
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
A clinical trial of Spinal Disorders/Injuries, sponsored by Orthofix.
- Active
- Registry status
- 2,000
- Enrollment target
- 20
- Study locations
NCT05082090: Active study of Spinal Disorders/Injuries, sponsored by Orthofix.
NCT05082090 is a study of Spinal Disorders/Injuries that is active but no longer recruiting, run by Orthofix. The registered enrollment target is 2,000 participants. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05082090, a study of Spinal Disorders/Injuries, is active but no longer recruiting, sponsored by Orthofix.
- ACTIVE NOT RECRUITING
- Registry status
- 2,000 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Evaluation of device related or procedure related adverse events
Conditions Studied
Interventions
- PROCEDURE Spinal Surgery
Study Locations (20)
Other
- Marien-Krankenhaus Bergisch Gladbach - Bergisch Gladbach
- Stenum Ortho GmbH - Ganderkesee
- Praxis für Neurochirurgie-Chirotherapie - Nordhausen
- Orthopädikum Potsdam - Potsdam
- Krankenhaus Maria-Hilf Stadtlohn - Stadtlohn
- The Club Surgical Centre - Pretoria
- Zuid-Afrikaans Hospital - Pretoria
- Hospital Clínic de Barcelona - Barcelona
- Hospital Vall d'Hebron - Barcelona
- Hospital Universitario Son Espases - Palma de Mallorca
- University Hospital Marqués de Valdecilla - Santander
California
- Lanman Spinal Neurosurgery - Beverly Hills
- RasouliSpine - Beverly Hills
- Neurosurgical Medical Clinic - San Diego
Louisiana
- Acadiana Neurosurgery - Lafayette
Mississippi
- Columbus Orthopaedic - Columbus
North Carolina
- M3 Emerging Medical Research - Durham
Rhode Island
- University Orthopedics - East Providence
Utah
- Summit Brain, Spine and Orthopedics - Lehi
Virginia
- Tuckahoe Orthopedics - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2021-09-15 |
| Est. Completion | 2031-12 |
What the registry record for NCT05082090 still lists
NCT05082090 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Spinal Disorders/Injuries appearing as the primary indexed condition, and to 1 intervention - of which Spinal Surgery is the first listed.
NCT05082090 names 20 study sites across 8 states, led by Other, California, Louisiana.
Frequently Asked Questions
What is clinical trial NCT05082090 about?
NCT05082090 is a clinical study titled "A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices". 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...
What is the current status of trial NCT05082090?
This trial is currently active not recruiting. The enrollment target is 2,000 participants. The study started on 2021-09-15. Estimated completion is 2031-12.
What conditions does trial NCT05082090 study?
This clinical trial studies the following conditions: Spinal Disorders/Injuries.
What interventions are being tested in trial NCT05082090?
The interventions under investigation include: Spinal Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT05082090?
This trial is sponsored by Orthofix, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05082090 being conducted?
This trial has 20 study locations across California, Louisiana, Mississippi, North Carolina, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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