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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-29

Study Completion Date

2027-04-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Degenerative Disc Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

CarboFix implant for spinal surgery

Group Type EXPERIMENTAL

Carbofix

Intervention Type PROCEDURE

Spinal stabilization using CarboFix screws and rods

Traditional

Titanium implant for spinal surgery

Group Type ACTIVE_COMPARATOR

Titanium

Intervention Type PROCEDURE

Spinal stabilization using titanium screws and rods

Interventions

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Titanium

Spinal stabilization using titanium screws and rods

Intervention Type PROCEDURE

Carbofix

Spinal stabilization using CarboFix screws and rods

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No