Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
NCT05082090 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05082090
The ClinicalTrials.gov registry entry for NCT05082090 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orthofix, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05082090 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, California, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05082090?
The interventions under investigation include: Spinal Surgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05082090?
This trial is sponsored by Orthofix, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.