Evaluation of a Carbon Fiber Device for Spinal Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the clinical and radiographic outcomes of using a carbon fiber pedicle screw system compared to traditional titanium devices in patients undergoing spinal fusion for degenerative spinal diseases. It aims to assess the effectiveness of the carbon device, which has previously shown promise in cancer patients due to its low interference with radiation and superior imaging capabilities. A total of 118 patients requiring 1 or 2 levels of lumbar or lumbosacral fusion will be included in the evaluation. The study seeks to fill a gap in the literature regarding the use of carbon fiber in lumbar degenerative pathologies.

Why it matters

Who can join: the full rules

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)

Where it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: Alessandro Gasbarrini, MD
• Email: alessandro.gasbarrini@ior.it
• Phone: 0516366

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.