Actively 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
Led by Istituto Ortopedico Rizzoli · Updated on 2025-01-17
118
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Metabolic bone disease
- History of Paget's disease or other osteodystrophies, 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Research Team
A
Alessandro Gasbarrini, MD
CONTACT
C
Cristiana Griffoni, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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