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

Running, not enrolling

Conditions studied: Spinal Disorders/Injuries

In brief

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 facts

Study ID

NCT05082090

Run by

Orthofix Inc.

People needed

2000

Starts

2021-09-15

Expected to finish

2031-12-01

Last updated by the study team

2025-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient diagnosed with a spine injury/disorder and undergoing or has undergone spine procedure at the participating investigative centers utilizing Orthofix Spine devices.
• Patient is 18 years or older at the time of surgery.
• Patient is capable of understanding the content of the patient information / Informed Consent Form (ICF) for the prospective segment of the study.
• Patient is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
• Note: For retrospective segment of the study: A waiver of consent for retrospective data collection is in place OR an informed consent is obtained from the participating patient prior to data collection as required by local regulations.

You may not qualify if…

• Patient may be excluded from study participation if there are other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render patient ineligible for the study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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