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

NCT06209684 | Recruiting DMC

• 1 other identifier: Carbofix degenerative
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Disc Disease

Keywords

degenerative spine disease

Outcome Measures

Primary Outcomes (1)

• Fusion rate

  Fusion rate after 12 months as demonstrated by computed tomography scan (CT scan). The CT scan will be evaluated by Brantigan scale.

  through study completion, an average of 1 year

Secondary Outcomes (18)

• Classification system of surgical complications specific for spine

  at baseline (day 0)

• Classification system of surgical complications specific for spine

  up to 12 months

• Visual Analogue Scale

  at baseline (day 0)

• Visual Analogue Scale

  after 12 months

• Visual Analogue Scale

  after 3 months

Study Arms (2)

Experimental

EXPERIMENTAL

CarboFix implant for spinal surgery

Procedure: Carbofix

Traditional

ACTIVE COMPARATOR

Titanium implant for spinal surgery

Procedure: Titanium

Interventions

Titanium PROCEDURE

Spinal stabilization using titanium screws and rods

Traditional

Carbofix PROCEDURE

Spinal stabilization using CarboFix screws and rods

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Titanium

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Metals, Light; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Alessandro Gasbarrini, MD

CONTACT

0516366; alessandro.gasbarrini@ior.it

Cristiana Griffoni, PhD

CONTACT

0516366; cristiana.griffoni@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 17, 2024
• Study Start: April 29, 2022
• Primary Completion: April 29, 2026
• Study Completion (Estimated): April 29, 2027
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)