A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
NCT ID: NCT05082090
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2000 participants
OBSERVATIONAL
2021-09-15
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Implanted with Orthofix Spinal products
Study will include 2000+ subjects implanted with Orthofix Spine devices including spine fixation systems and motion preservation systems (i.e. M6-C artificial cervical disc and M6-L artificial lumbar disc)
Spinal Surgery
Implanted with Orthofix Spinal products
Interventions
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Spinal Surgery
Implanted with Orthofix Spinal products
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Orthofix Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cahit Akbas
Role: STUDY_DIRECTOR
Global Clinical Program Manager
Locations
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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
Countries
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Other Identifiers
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CP-2001SPPM
Identifier Type: -
Identifier Source: org_study_id
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