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Carbofix Pedicle Screw System: Evaluation of the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases

Comparing carbon fiber vs. titanium devices for spinal fusion outcomes.

Recruiting
18 years and older
All
Phase N/A

This study examines a new type of device called the Carbofix Pedicle Screw System for patients needing spinal fusion surgery due to degenerative spinal diseases. Degenerative spinal diseases occur when the spine wears down, causing pain or other issues. The study compares a carbon fiber device with traditional titanium devices. Carbon fiber allows for clearer imaging during exams like MRI and CT scans, and minimizes interference with radiation used in treatments like radiotherapy.

The study involves 118 patients who need spinal fusion (joining of two or more bones in the spine) in the lower back, on either one or two levels. Participants need to be 18 or older, able to understand the study, and provide consent. Patients with certain conditions, such as metabolic bone diseases, psychiatric disorders, or pregnancy, are excluded.

  • The study requires follow-up visits after the procedure to monitor outcomes.
  • No compensation is mentioned for participating in the study.
  • Risks include those generally associated with spinal surgery.
Study details
    Degenerative Disc Disease

NCT06209684

Istituto Ortopedico Rizzoli

24 January 2024

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