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ACTIVE NOT RECRUITING
NCT05082090

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

Sponsor: Orthofix Inc.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2021-09-15

Completion Date

2031-12

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

PROCEDURE

Spinal Surgery

Implanted with Orthofix Spinal products

Locations (20)

Lanman Spinal Neurosurgery

Beverly Hills, California, United States

RasouliSpine

Beverly Hills, California, United States

Neurosurgical Medical Clinic

San Diego, California, United States

Acadiana Neurosurgery

Lafayette, Louisiana, United States

Columbus Orthopaedic

Columbus, Mississippi, United States

M3 Emerging Medical Research

Durham, North Carolina, United States

University Orthopedics

East Providence, Rhode Island, United States

Summit Brain, Spine and Orthopedics

Lehi, Utah, United States

Tuckahoe Orthopedics

Richmond, Virginia, United States

Marien-Krankenhaus Bergisch Gladbach

Bergisch Gladbach, Germany

Stenum Ortho GmbH

Ganderkesee, Germany

Praxis für Neurochirurgie-Chirotherapie

Nordhausen, Germany

Orthopädikum Potsdam

Potsdam, Germany

Krankenhaus Maria-Hilf Stadtlohn

Stadtlohn, Germany

The Club Surgical Centre

Pretoria, South Africa

Zuid-Afrikaans Hospital

Pretoria, South Africa

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Spain

University Hospital Marqués de Valdecilla

Santander, Spain