Evaluating the performance of Orthofix spine devices for spinal disorders

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

This study is testing how well Orthofix spine devices work and are safe for people with spinal injuries or disorders in real-life situations.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Orthofix Inc. (industry)
• Locations: 20 sites (Beverly Hills, California and 19 other locations)
• Trial ID: NCT05082090 on ClinicalTrials.gov

What this trial studies

This study collects real-world data on the safety and performance of Orthofix spine devices used in patients with spinal injuries or disorders. It involves both prospective and retrospective data collection from patients who have undergone spine procedures at participating centers. The aim is to generate evidence that supports compliance with global regulatory requirements, including the European Medical Device Regulation. The study will help assess how well these devices perform in real-world clinical settings.

Who should consider this trial

Good fit: Ideal candidates include patients aged 18 and older diagnosed with a spine injury or disorder who are undergoing or have undergone a spine procedure using Orthofix devices.

Not a fit: Patients with concurrent medical conditions that may interfere with the study or those not undergoing procedures with Orthofix devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of the effectiveness and safety of Orthofix spine devices, leading to improved patient outcomes.

How similar studies have performed: Other studies evaluating the performance of medical devices in real-world settings have shown success, indicating that this approach is both relevant and valuable.

Eligibility criteria

Inclusion Criteria:

1. Patient diagnosed with a spine injury/disorder and undergoing or has undergone spine procedure at the participating investigative centers utilizing Orthofix Spine devices.
2. Patient is 18 years or older at the time of surgery.
3. Patient is capable of understanding the content of the patient information / Informed Consent Form (ICF) for the prospective segment of the study.
4. 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.

Exclusion criteria:

1. 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 this trial is running

Beverly Hills, California and 19 other locations

• Lanman Spinal Neurosurgery — Beverly Hills, California, United States (ENROLLING_BY_INVITATION)
• RasouliSpine — Beverly Hills, California, United States (ENROLLING_BY_INVITATION)
• Neurosurgical Medical Clinic — San Diego, California, United States (RECRUITING)
• Acadiana Neurosurgery — Lafayette, Louisiana, United States (ENROLLING_BY_INVITATION)
• Columbus Orthopaedic — Columbus, Mississippi, United States (RECRUITING)
• M3 Emerging Medical Research — Durham, North Carolina, United States (ENROLLING_BY_INVITATION)
• University Orthopedics — East Providence, Rhode Island, United States (RECRUITING)
• Summit Brain, Spine and Orthopedics — Lehi, Utah, United States (RECRUITING)
• Tuckahoe Orthopedics — Richmond, Virginia, United States (RECRUITING)
• Marien-Krankenhaus Bergisch Gladbach — Bergisch Gladbach, Germany (NOT_YET_RECRUITING)
• Stenum Ortho GmbH — Ganderkesee, Germany (RECRUITING)
• Praxis für Neurochirurgie-Chirotherapie — Nordhausen, Germany (RECRUITING)
• Orthopädikum Potsdam — Potsdam, Germany (RECRUITING)
• Krankenhaus Maria-Hilf Stadtlohn — Stadtlohn, Germany (RECRUITING)
• The Club Surgical Centre — Pretoria, South Africa (RECRUITING)
• Zuid-Afrikaans Hospital — Pretoria, South Africa (RECRUITING)
• Hospital Clínic de Barcelona — Barcelona, Spain (RECRUITING)
• Hospital Vall d'Hebron — Barcelona, Spain (RECRUITING)
• Hospital Universitario Son Espases — Palma De Mallorca, Spain (NOT_YET_RECRUITING)
• University Hospital Marqués de Valdecilla — Santander, Spain (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Cahit Akbas, MSc

Conditions: Spinal Disorders/Injuries