Carbofix Pedicle Screw System Randomized Trial Comparing Carbon Fiber and Titanium Implants in Spinal Fusion for Degenerative Spinal Diseases

What this Trial Is About

Researchers are evaluating the clinical and radiographic outcomes of using a carbon fiber pedicle screw system compared to traditional titanium devices in patients undergoing spinal fusion surgery for degenerative spinal diseases. This study focuses on adults with degenerative disc disease or spondylolisthesis who require stabilization of one or two lumbar or lumbosacral levels. The rationale includes the potential advantages of carbon fiber devices, such as minimal interference with radiotherapy and improved imaging visibility compared to titanium devices. Participants will receive spinal stabilization using either CarboFix carbon fiber screws and rods or titanium screws and rods. The study involves a randomized clinical trial design comparing these two procedures. The primary outcome measure is the fusion rate assessed throughout the study, which lasts an average of one year. No other treatment details or extension phases are described. During the study, participants will be monitored for fusion success and undergo clinical and radiographic evaluations. Follow-up visits will assess the stability and healing of the spinal fusion. Participants are required to understand and sign informed consent and comply with follow-up schedules. The total duration of participation is approximately one year, focusing on the effectiveness and imaging outcomes of the two types of spinal stabilization devices.

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