Status:
RECRUITING
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
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 stabilizatio...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 29 2027
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06209684
Start Date
April 29 2022
End Date
April 29 2027
Last Update
January 17 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136