MedTrace Logo

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

NCT05082090 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2025-07-30

No results posted yet for this 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

  • Spinal Disorders/Injuries

Interventions

PROCEDURE

Spinal Surgery

Implanted with Orthofix Spinal products

Sponsors & Collaborators

  • Orthofix Inc.

    lead INDUSTRY

Principal Investigators

  • Cahit Akbas · Global Clinical Program Manager

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2031-12-31
Completion
2031-12-31

Countries

  • United States
  • Germany
  • South Africa
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05082090 on ClinicalTrials.gov