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
| NCT ID | NCT06209684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Degenerative Disc Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2022-04-29 |
| Primary Completion | 2026-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 118 participants in total. It began in 2022-04-29 with a primary completion date of 2026-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06209684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Degenerative Disc Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06209684 currently recruiting?
Yes, NCT06209684 is actively recruiting participants. Contact the research team at alessandro.gasbarrini@ior.it for enrollment information.
Where is the NCT06209684 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06209684 clinical trial?
NCT06209684 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 118 participants.