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Clinical Trials in Italy / NCT06209684
Recruiting Not applicable

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

NCT06209684 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Not applicable
Started
2022-04-29
Last updated
2026-05-22

Condition(s) studied

Degenerative Disc Disease

Investigational drug(s) / intervention(s)

TitaniumCarbofix

Titanium: Spinal stabilization using titanium screws and rods

Carbofix: Spinal stabilization using CarboFix screws and rods

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Fusion rate — through study completion, an average of 1 year
    Fusion rate after 12 months as demonstrated by computed tomography scan (CT scan). The CT scan will be evaluated by Brantigan scale.

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Italy Recruiting

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Other trials for the same condition

The European Robotic Spinal Instrumentation (EUROSPIN) Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06209684 on ClinicalTrials.gov ↗ ← All trials in Italy