clinical trial · NCT05082090
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
Orthofix Inc.·—·active not recruiting·n = 2,000
Spinal Disorders/InjuriesSpinal Surgery
brief 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.
started
Sep 15, 2021
primary completion
Dec 1, 2031
completion
Dec 1, 2031
last updated
Jul 30, 2025
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol