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

Last updated: April 11, 2024
Sponsor: Orthofix Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Spinal Surgery

Clinical Study ID

NCT05082090
CP-2001SPPM
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient diagnosed with a spine injury/disorder and undergoing or has undergone spineprocedure 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 / InformedConsent Form (ICF) for the prospective segment of the study.
  4. Patient is willing and able to participate in the prospective data collection protocoland comply with the required data collection. Note: For retrospective segment of the study: A waiver of consent for retrospective datacollection is in place OR an informed consent is obtained from the participating patientprior to data collection as required by local regulations.

Exclusion

Exclusion criteria:

  1. Patient may be excluded from study participation if there are other concurrent medicalor other conditions (chronic or acute in nature) that in the opinion of the participatinginvestigator may prevent participation or otherwise render patient ineligible for thestudy.

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: Spinal Surgery
Phase:
Study Start date:
September 15, 2021
Estimated Completion Date:
December 31, 2031

Connect with a study center

  • Marien-Krankenhaus Bergisch Gladbach

    Bergisch Gladbach,
    Germany

    Site Not Available

  • Stenum Ortho GmbH

    Ganderkesee, 27777
    Germany

    Active - Recruiting

  • Praxis für Neurochirurgie-Chirotherapie

    Nordhausen,
    Germany

    Active - Recruiting

  • Orthopädikum Potsdam

    Potsdam, 14482
    Germany

    Active - Recruiting

  • Krankenhaus Maria-Hilf Stadtlohn

    Stadtlohn,
    Germany

    Active - Recruiting

  • The Club Surgical Centre

    Pretoria,
    South Africa

    Active - Recruiting

  • Zuid-Afrikaans Hospital

    Pretoria,
    South Africa

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Vall d'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario Son Espases

    Palma De Mallorca,
    Spain

    Site Not Available

  • University Hospital Marqués de Valdecilla

    Santander,
    Spain

    Site Not Available

  • Lanman Spinal Neurosurgery

    Beverly Hills, California 90210
    United States

    Site Not Available

  • RasouliSpine

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Neurosurgical Medical Clinic

    San Diego, California 92111
    United States

    Active - Recruiting

  • Acadiana Neurosurgery

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • Columbus Orthopaedic

    Columbus, Mississippi 39705
    United States

    Active - Recruiting

  • M3 Emerging Medical Research

    Durham, North Carolina 27704
    United States

    Site Not Available

  • University Orthopedics

    East Providence, Rhode Island 02914
    United States

    Active - Recruiting

  • Summit Brain, Spine and Orthopedics

    Lehi, Utah 84043
    United States

    Active - Recruiting

  • Tuckahoe Orthopedics

    Richmond, Virginia 23226
    United States

    Active - Recruiting

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