Clinical Trial

A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices

Study acronym: RWE Spine
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-10-05; most recent amendment 2025-07-25.
Status change: Recruiting → Active, Not Recruiting 2025-07-25
Trial Details
NCT Number NCT05082090
Lead Sponsor Orthofix Inc.
Conditions Spinal Disorders/Injuries
Enrollment 2,000 participants
Start Date 2021-09-15
Primary Completion 2031-12 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-30