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Compares treatment options for Degenerative Disc Disease
Official title 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
ClinicalTrials.gov ID: NCT06209684
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Metabolic bone disease.
- History of Paget's disease or other osteodystrophies, whether acquired or congenital, including renal osteodystrophy, hyperthyroidism...
- Neoplastic disease.
- History of mental disorder or current psychiatric treatment.
- Pregnancy.
- Immunodeficiency diseases.
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.