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

Last updated: January 16, 2025
Sponsor: Istituto Ortopedico Rizzoli
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Carbofix

Titanium

Clinical Study ID

NCT06209684
Carbofix degenerative
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients suffering from degenerative spinal pathology or spondylolisthesis whorequire 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 therequired follow-ups.

Exclusion

Exclusion Criteria:

  • Metabolic bone disease.

  • History of Paget's disease or other osteodystrophies, whether acquired orcongenital, 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 therequired follow-up visits.

  • Alcohol and/or drug abuse

  • Obesity

  • Metal allergy

  • Participation in other studies on drugs or devices (within 30 days)

Study Design

Total Participants: 118
Treatment Group(s): 2
Primary Treatment: Carbofix
Phase:
Study Start date:
April 29, 2022
Estimated Completion Date:
April 29, 2027

Connect with a study center

  • Istituto Ortopedico Rizzoli

    Bologna, 40136
    Italy

    Active - Recruiting

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