Carbofix Pedicle Screw System: Evaluation of the Clinical and Radiographic Outcomes of the Use of… (NCT06209684) | Clinical Trial Compass
RecruitingNot 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
Italy118 participantsStarted 2022-04-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fusion rate
Timeframe: through study completion, an average of 1 year