About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Titanium
Procedure/SurgerySpinal stabilization using titanium screws and rods
Carbofix
Procedure/SurgerySpinal stabilization using CarboFix screws and rods
Treatment groups
Trial outcomes
Primary outcomes
Fusion rate
Fusion rate after 12 months as demonstrated by computed tomography scan (CT scan). The CT scan will be evaluated by Brantigan scale.
Secondary outcomes
Classification system of surgical complications specific for spine
rate of intra-operative complications evaluated by SAVES classification system specific for spine
Classification system of surgical complications specific for spine
rate of post-operative complications evaluated by SAVES classification system specific for spine
Visual Analogue Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Visual Analogue Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Sponsors and contacts
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