Degenerative Disc DiseaseNCT02039232
Safety and Efficacy of the CarboFix Pedicle Screw System
A study testing Pedicle screw system in people with Degenerative Disc Disease and Spondylolisthesis, run by CarboFix Orthopedics Ltd. at 2 sites in Israel.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- What is being tested?
- Pedicle screw system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject is 18 years old or older.
- Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.
- Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.
- Informed consent given by the subject.
Who cannot join
- Subject is not eligible for fixation with market-available fixation means.
- Familial history NF2.
- Acute traumatic spinal injury with or without neurological signs.
- Metabolic bone disease.
- History of Paget's disease or other osteodystrophies whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
- History of mental disorder or current psychiatric treatment.
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- Pregnancy and/or female subjects intending to become pregnant within the expected time frame of the study and/or female subjects of child bearing age who do not use conventional contraceptive methods.
- Immune deficiency disease.
- Infection in the location of the operative site, discitis, osteomyelitis, fever and/or leukocytosis (as diagnosed based on the results of CBC and ESR tests).
- Scoliosis.
- Treatment with drugs that may interfere with bone metabolism such as:
- Cumulative dose of 150 mg. of Prednisone or equivalent within the last 6 months.
- Calcitonin within the past 6 months.
- Bisphosphonates for 30 days or more within the last 12 months.
- Bone therapeutic doses of fluoride for 30 days or more within the last 12 months.
- Bone therapeutic doses of vitamin D or Vitamin D metabolites for 30 days or more within the last 6 months.
- Treatment by chemotherapy within the last 12 months.
- Lack of willingness to make a commitment to return for required follow up visits.
- Drug and/or alcohol abuse.
- Morbid obesity.
- Metal allergies.
- Recent use of other investigational drugs or devices (within the past 30 days).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: CarboFix Pedicle Screw System
The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine.
- Being tested
- Pedicle screw system
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Spinal Stenosis, Spinal Curvatures, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedicle screw systemDevice
| Study group | Role | What they receive |
|---|---|---|
| CarboFix Pedicle Screw System | Experimental | Not described Receives: Device: Pedicle screw system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion success
Measured: 6 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- CarboFix Orthopedics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039232
- Sponsor's protocol ID
- CARBOFIX P CLD PPS1
- Status last verified
- Apr 2018
- First submitted
- 14 Jan 2014
- Last updated
- 17 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CarboFix Pedicle Screw System
- ClinicalTrials.gov ID
- NCT02039232
- Acronym / sponsor ID
- CARBOFIX P CLD PPS1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- CarboFix Orthopedics Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 17 Jan 2014 (estimated)
- 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.
The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CarboFix Pedicle Screw System | Experimental | Device: Pedicle screw system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is 18 years old or older.
- Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.
- Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.
- Informed consent given by the subject.
Key exclusion criteria (22 listed)
- Subject is not eligible for fixation with market-available fixation means.
- Familial history NF2.
- Acute traumatic spinal injury with or without neurological signs.
- Metabolic bone disease.
- History of Paget's disease or other osteodystrophies whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
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 |
|---|---|---|
| Pedicle screw system | Device | CarboFix Pedicle Screw System |
Primary outcome
Fusion success
Time frame: 6 months post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedicle screw system in people with Degenerative Disc Disease and Spondylolisthesis, run by CarboFix Orthopedics Ltd. at 2 sites in Israel.
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 4 inclusion and 22 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: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion success (time frame: 6 months post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.