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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

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What is being tested

Titanium

+ Carbofix

Procedure
Who is being recruted

Bone Diseases+1

+ Musculoskeletal Diseases

+ Spinal Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2022
See protocol details

Summary

Principal SponsorIstituto Ortopedico Rizzoli
Study ContactAlessandro Gasbarrini, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 29, 2022

Actual date on which the first participant was enrolled.

This clinical trial aims to compare the outcomes of using a carbon fiber device versus traditional titanium devices in patients who need spinal fusion surgery due to degenerative spinal diseases. Degenerative spinal diseases involve the gradual deterioration of the spine, leading to pain and mobility issues. The study focuses on patients requiring fusion at one or two levels in the lower back region. Carbon fiber devices are of interest because they do not interfere with imaging techniques like MRI and X-rays and have previously been used effectively in cancer patients undergoing radiation therapy. This trial could reveal whether carbon fiber offers better or comparable results to titanium, which is the standard material currently used. Participants in the study will undergo spinal fusion surgery, where either a carbon fiber or titanium device will be implanted to stabilize the spine. The study will observe the clinical and radiographic outcomes, meaning it will look at both the physical recovery and the images of the spine post-surgery to assess how well the devices are working. By comparing these two materials, researchers hope to determine which provides better stabilization and visualization benefits without compromising the patient's recovery or effectiveness of the treatment.

Official TitleCarbofix 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
NCT06209684
Principal SponsorIstituto Ortopedico Rizzoli
Study ContactAlessandro Gasbarrini, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

118 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesMusculoskeletal DiseasesSpinal DiseasesIntervertebral Disc Degeneration

Criteria

3 inclusion criteria required to participate
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.

13 exclusion criteria prevent from participating
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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Titanium implant for spinal surgery

Group II

Experimental
CarboFix implant for spinal surgery

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Istituto Ortopedico Rizzoli

Bologna, ItalyOpen Istituto Ortopedico Rizzoli in Google Maps
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One Study Center