Evaluation of a Carbon Fiber Device for Spinal Surgery
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
This study is testing a new carbon fiber device for spinal surgery to see if it works better than traditional titanium screws for patients with degenerative spinal diseases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06209684 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical and radiographic outcomes of using a carbon fiber pedicle screw system compared to traditional titanium devices in patients undergoing spinal fusion for degenerative spinal diseases. It aims to assess the effectiveness of the carbon device, which has previously shown promise in cancer patients due to its low interference with radiation and superior imaging capabilities. A total of 118 patients requiring 1 or 2 levels of lumbar or lumbosacral fusion will be included in the evaluation. The study seeks to fill a gap in the literature regarding the use of carbon fiber in lumbar degenerative pathologies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older suffering from degenerative spinal pathology or spondylolisthesis requiring instrumented stabilization.
Not a fit: Patients with metabolic bone diseases, neoplastic diseases, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective option for spinal stabilization in patients with degenerative spinal diseases.
How similar studies have performed: While previous studies have shown the effectiveness of carbon devices in cancer patients, this approach in degenerative spinal conditions is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients suffering from degenerative spinal pathology or spondylolisthesis who require instrumented stabilization on 1-2 levels; * Age greater than or equal to 18 years; * Ability to understand and sign the informed consent to the study and to follow the required follow-ups. Exclusion Criteria: * Metabolic bone disease. * History of Paget's disease or other osteodystrophies, whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism, Ehlers-Danlos syndrome, osteogenesis imperfecta, achondroplasia. * Neoplastic disease. * History of mental disorder or current psychiatric treatment. * Pregnancy. * Immunodeficiency diseases. * Infectious bone disease (discitis, osteomyelitis) * Treatment with drugs that can interfere with bone metabolism * Inability to understand and sign the informed consent to the study and to follow the required follow-up visits. * Alcohol and/or drug abuse * Obesity * Metal allergy * Participation in other studies on drugs or devices (within 30 days)
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro Gasbarrini, MD
- Email: alessandro.gasbarrini@ior.it
- Phone: 0516366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.