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A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
Sponsor: Orthofix Inc.
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
Conditions
Interventions
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