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

I

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Degenerative Disc Disease

Treatments

Procedure: Carbofix
Procedure: Titanium

Study type

Interventional

Funder types

Other

Identifiers

NCT06209684
Carbofix degenerative

Details and patient eligibility

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.

Enrollment

118 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

118 participants in 2 patient groups

Experimental
Experimental group
Description:
CarboFix implant for spinal surgery
Treatment:
Procedure: Carbofix
Traditional
Active Comparator group
Description:
Titanium implant for spinal surgery
Treatment:
Procedure: Titanium

Trial contacts and locations

1

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Central trial contact

Cristiana Griffoni, PhD; Alessandro Gasbarrini, MD

Data sourced from clinicaltrials.gov

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