Degenerative Disc DiseaseNCT06209684
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
A study testing Titanium and Carbofix in people with Degenerative Disc Disease, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Titanium and Carbofix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteItaly
- Study dates
- 29 Apr 2022to 29 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Alessandro Gasbarrini, MD, alessandro.gasbarrini@ior.it
Cristiana Griffoni, PhD
About this study
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
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
- Being tested
- Titanium, Carbofix
- Keywords
- degenerative spine disease
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TitaniumProcedure or surgery
Spinal stabilization using titanium screws and rods
CarbofixProcedure or surgery
Spinal stabilization using CarboFix screws and rods
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | CarboFix implant for spinal surgery Receives: Procedure: Carbofix |
| Traditional | Active comparator | Titanium implant for spinal surgery Receives: Procedure: Titanium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion rate
Fusion rate after 12 months as demonstrated by computed tomography scan (CT scan).
The CT scan will be evaluated by Brantigan scale.
Measured: through study completion, an average of 1 year
Secondary outcomes (18)
Classification system of surgical complications specific for spine
rate of intra-operative complications evaluated by SAVES classification system specific for spine
Measured: at baseline (day 0)
Classification system of surgical complications specific for spine
rate of post-operative complications evaluated by SAVES classification system specific for spine
Measured: up to 12 months
Visual Analogue Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Measured: at baseline (day 0)
Visual Analogue Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Measured: after 12 months
Visual Analogue Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Measured: after 3 months
Visual Analogue Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Measured: after 6 months
Oswestry Disability Index
The Oswestry Disability Index (ODI) is a self-administered and validated questionnaire in Italian which aims to evaluate disabilities in subjects suffering from low back pain in both the acute and chronic phases.
Measured: at baseline (day 0)
Oswestry Disability Index
The Oswestry Disability Index (ODI) is a self-administered and validated questionnaire in Italian which aims to evaluate disabilities in subjects suffering from low back pain in both the acute and chronic phases.
Measured: after 12 months
Oswestry Disability Index
The Oswestry Disability Index (ODI) is a self-administered and validated questionnaire in Italian which aims to evaluate disabilities in subjects suffering from low back pain in both the acute and chronic phases.
Measured: after 3 months
Oswestry Disability Index
The Oswestry Disability Index (ODI) is a self-administered and validated questionnaire in Italian which aims to evaluate disabilities in subjects suffering from low back pain in both the acute and chronic phases.
Measured: after 6 months
EuroQoL-5D
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition
Measured: at baseline (day 0)
EuroQoL-5D
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition
Measured: after 12 months
EuroQoL-5D
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition
Measured: after 3 months
EuroQoL-5D
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition
Measured: after 6 months
Short Form-12
The SF-12 is composed of 12 items (derived from the 36 of the original SF-36 questionnaire) which produce two measures relating to two different aspects of health: physical health and mental health.
The SF-12 is made up of 4 scales (physical functioning, role and physical health, role and emotional state, mental health) measured by 2 items each and 4 scales each measured by one item (physical pain, vitality, social activities and general health).
Measured: at baseline (day 0)
Short Form-12
The SF-12 is composed of 12 items (derived from the 36 of the original SF-36 questionnaire) which produce two measures relating to two different aspects of health: physical health and mental health.
The SF-12 is made up of 4 scales (physical functioning, role and physical health, role and emotional state, mental health) measured by 2 items each and 4 scales each measured by one item (physical pain, vitality, social activities and general health).
Measured: after 12 months
Short Form-12
The SF-12 is composed of 12 items (derived from the 36 of the original SF-36 questionnaire) which produce two measures relating to two different aspects of health: physical health and mental health.
The SF-12 is made up of 4 scales (physical functioning, role and physical health, role and emotional state, mental health) measured by 2 items each and 4 scales each measured by one item (physical pain, vitality, social activities and general health).
Measured: after 3 months
Short Form-12
The SF-12 is composed of 12 items (derived from the 36 of the original SF-36 questionnaire) which produce two measures relating to two different aspects of health: physical health and mental health.
The SF-12 is made up of 4 scales (physical functioning, role and physical health, role and emotional state, mental health) measured by 2 items each and 4 scales each measured by one item (physical pain, vitality, social activities and general health).
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start29 Apr 2022
- Primary completion29 Sep 2026 (estimated)
- Study completion29 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209684
- Sponsor's protocol ID
- Carbofix degenerative
- Status last verified
- May 2026
- First submitted
- 4 Jan 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 28815357Boriani 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.
PubMed 32691220Vaccaro 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.
PubMed 10795032
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06209684
- Acronym / sponsor ID
- Carbofix degenerative
- Conditions
- Degenerative Disc Disease
- Keywords
- degenerative spine disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 29 Apr 2027 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: CarbofixCarboFix implant for spinal surgery |
| Traditional | Active comparator | Procedure: TitaniumTitanium implant for spinal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TitaniumSpinal stabilization using titanium screws and rods | Procedure or surgery | Traditional |
| CarbofixSpinal stabilization using CarboFix screws and rods | Procedure or surgery | Experimental |
Primary outcome
Fusion rate
Time frame: through study completion, an average of 1 year
Fusion rate after 12 months as demonstrated by computed tomography scan (CT scan). The CT scan will be evaluated by Brantigan scale.
18 secondary outcomes
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
EuroQoL-5D
Time frame: after 3 months
EuroQoL-5D
Time frame: after 6 months
Short Form-12
Time frame: at baseline (day 0)
Short Form-12
Time frame: after 12 months
Short Form-12
Time frame: after 3 months
Short Form-12
Time frame: after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 28815357Boriani 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.
- Background: PubMed 32691220Boriani 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.
- Results publication: PubMed 10795032Vaccaro 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium and Carbofix in people with Degenerative Disc Disease, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Gasbarrini, MD (0516366 ext. 130, alessandro.gasbarrini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion rate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06209684, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.