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Recruiting NCT06209684

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

No phase Interventional Degenerative Disc Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Titanium, Carbofix.
Who it may be relevant to
Registry conditions: Degenerative Disc Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Carbofix Pedicle Screw System: Randomized Clinical Trial to Evaluate 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

Overview

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.

Interventions

  • Procedure Titanium
    Spinal stabilization using titanium screws and rods
  • Procedure Carbofix
    Spinal stabilization using CarboFix screws and rods

Primary outcome measures

  • Fusion rate [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (12)
  • Classification system of surgical complications specific for spine [Time frame: at baseline (day 0)]
  • Classification system of surgical complications specific for spine [Time frame: up to 12 months]
  • Visual Analogue Scale [Time frame: at baseline (day 0)]
  • Visual Analogue Scale [Time frame: after 12 months]
  • Visual Analogue Scale [Time frame: after 3 months]
  • Visual Analogue Scale [Time frame: after 6 months]
  • Oswestry Disability Index [Time frame: at baseline (day 0)]
  • Oswestry Disability Index [Time frame: after 12 months]
  • Oswestry Disability Index [Time frame: after 3 months]
  • Oswestry Disability Index [Time frame: after 6 months]
  • EuroQoL-5D [Time frame: at baseline (day 0)]
  • EuroQoL-5D [Time frame: after 12 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Istituto Ortopedico Rizzoli — Bologna

Publications

  • Boriani S, Tedesco G, Ming L, Ghermandi R, Amichetti M, Fossati P, Krengli M, Mavilla L, Gasbarrini A. Carbon-fiber-reinforced PEEK fixation system in the treatment of spine tumors: a preliminary report. Eur Spine J. 2018 Apr;27(4):874-881. doi: 10.1007/s00586-017-5258-5. Epub 2017 Aug 16. PMID 28815357
  • Boriani S, Pipola V, Cecchinato R, Ghermandi R, Tedesco G, Fiore MR, Dionisi F, Gasbarrini A. Composite PEEK/carbon fiber rods in the treatment for bone tumors of the cervical spine: a case series. Eur Spine J. 2020 Dec;29(12):3229-3236. doi: 10.1007/s00586-020-06534-0. Epub 2020 Jul 20. PMID 32691220
  • Vaccaro AR, Garfin SR. Pedicle-Screw Fixation in the Lumbar Spine. J Am Acad Orthop Surg. 1995 Oct;3(5):263-274. doi: 10.5435/00124635-199509000-00002. PMID 10795032

Identifiers

NCT: NCT06209684 · Carbofix degenerative

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗