NCT06209684

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

Carbofix Pedicle Screw System: Randomized Clinical Trial to Evaluate 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Previous clinical study carried out on cancer patients at IOR Spine Surgery (approved in October 2014). The carbon device is indicated in patients suffering from vertebral tumors who need stabilization and will then carry out radiotherapy, because carbon has a practically zero level of interference with ionizing radiation. Carbon also allows for better visualization of the implants on MRI/CT and X-ray. There are no studies in the literature analyzing the use of carbon fiber devices in lumbar degenerative pathologies. 118 patients suffering from degenerative spinal pathology requiring 1 or 2 levels of lumbar or lumbosacral fusion will be valutated.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
PROCEDURE	Titanium	Spinal stabilization using titanium screws and rods
PROCEDURE	Carbofix	Spinal stabilization using CarboFix screws and rods

Timeline

• Start date: 2022-04-29
• Primary completion: 2026-04-29
• Completion: 2027-04-29
• First posted: 2024-01-17
• Last updated: 2025-01-17

Locations

1 site across 1 country: Italy