Carbofix Pedicle Screw System: Randomized Clinical Trial to Evaluate Clinical and Radiographic Outcomes of Carbon Fiber Versus Titanium Devices in Spinal Arthrodesis for Degenerative Spinal Diseases

What this Trial Is About

Researchers are studying patients with degenerative spinal diseases who need spinal fusion surgery involving one or two lumbar or lumbosacral levels. The trial compares clinical and imaging outcomes between a carbon fiber implant system and traditional titanium devices. Carbon fiber implants have been previously studied in cancer patients for spinal stabilization due to their low interference with radiation and better imaging visibility, but their use in degenerative spine conditions has not been evaluated before. Participants will be randomly assigned to receive either the CarboFix carbon fiber implant or the standard titanium implant for spinal surgery. Both involve spinal stabilization with screws and rods. The study will follow patients for an average of one year to assess the fusion success rate. Various secondary measures will also be evaluated including surgical complications, pain levels, disability, and quality of life at multiple time points from baseline through 12 months. During the study, participants will undergo assessments including clinical evaluations and questionnaires such as the Visual Analogue Scale for pain, Oswestry Disability Index, EuroQoL-5D, and Short Form-12 at baseline, 3, 6, and 12 months. Safety and complications specific to spine surgery will be monitored throughout. The total study duration for each participant is about one year, including follow-up visits to evaluate the outcomes and implant performance.

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