Degenerative Disc DiseaseNCT02626624

Safety and Efficacy of the CarboClear Pedicle Screw System

A study testing Implantation of the CarboClear Pedicle Screw System in people with Degenerative Disc Disease and Spondylolisthesis, Grade 1, run by CarboFix Orthopedics Ltd. at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device, and requiring immediate, rigid, posterior spinal stabilization of the lumbar and/or sacral… Read more about this study

Who is it for?: Ages 21 to 72 years
Conditions the study is for: Degenerative Disc Disease, Spondylolisthesis, Grade 1
What is being tested?: Implantation of the CarboClear Pedicle Screw System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 8 sitesin 2 countries
Study dates: 27 Dec 2015to 28 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 72 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has degenerative disc disease (DDD) at one level, from L2 to S1 vertebrae, with up to Grade I spondylolisthesis.
DDD is defined as back pain and/or radicular leg pain with degeneration of the disc confirmed by patient history, radiographic studies, and physical examination, with one or more of the following factors (as measured radiographically, either by CT, MRI or plain film, myelography, discography, etc.):
osteophyte formation of facet joints or vertebral endplates;
decreased disc height, on average by > 2 mm;
scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;
herniated nucleus pulposus;

Show all 16Show fewer

facet joint degeneration/changes;
vacuum phenomenon.
Subject is candidate for single level intervertebral fusion, with or without posterolateral fusion, with implantation of intervertebral body fusion device and supplemental fixation.
Subject age is between 21 - 72 years, and subject is skeletally mature.
Pre-operative low back and/or leg/s pain (debilitating pain that causes a significant disturbance of the routine daily physical activities) ≥ 40 mm on a 100 mm Visual Analogue Scale (VAS).
Pre-operative Oswestry Disability Index (ODI) score ≥ 40 percentage-point, indicating at least moderate disability (interpreted as moderate/severe disability).
Low back and/or leg/s pain is unresponsive to prior non-surgical management for a minimum of six months. Non-operative treatment includes pain medication, physical therapy and/or injections.
Patient must understand and sign the informed consent.
Patient is willing and able to meet the proposed follow-up schedule including return to follow-up visits and complete necessary study paperwork.
Patient is willing and able to follow the postoperative management program.

Who cannot join

Previous fusion or fusion attempts, including anterior fusion or posterolateral fusion, at the index level.
Previous fusion or fusion attempts at the adjacent levels.
Prior decompression procedures that include removal of soft and bone tissue at the index or adjacent levels.
Patient is not skeletally mature.
Degenerative spondylolisthesis greater than Grade I.
Spinal instability at the index level with ≥ 3 mm translation and/or ≥ 5 degrees angulation. Determination of instability will be assessed using flexion/extension lateral view radiographs.

Show all 34Show fewer

Isthmic spondylolisthesis.
Radiographically confirmed moderate or severe spinal stenosis with associated neurogenic claudication. Radiographically confirmed moderate/severe stenosis is defined as reduction of ˃50% of central and/or foraminal canal diameter compared to the adjacent uninvolved levels. Neurogenic claudication is leg, groin or buttock pain and/or numbness that worsens with walking or erect posture and is relieved with flexion of the spine.
Systemic infection or infection at the site of surgery.
Metabolic bone disease, such as osteopenia, osteoporosis, and osteomalacia. A screening Questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required, exclusion will be defined as measured T-score less than or equal to -2.5 (WHO definition).
History of Paget's disease or other bone pathologies, whether acquired or congenital, including renal osteodystrophy, untreated or uncontrolled hyperthyrodism, hypothyroidism, hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
Personal and/or familial history NF2, and/or spinal tumor.
Ankylosing spondylitis.
Diffuse idiopathic skeletal hyperostosis (DISH) syndrome.
Active hepatitis (viral or serum) or HIV positive, renal failure, systemic lupus erythematosus, or any other significant medical conditions which would substantially increase the risk of surgery.
Immune deficiency disease.
Patient is receiving immunosuppressive or long-term steroid therapy.
Active malignancy or other significant medical comorbidities.
All concomitant diseases that can jeopardize the functioning and success of the patient.
Allergy to any component of the investigational device, including carbon fiber-reinforced polyetheretherketone (CFR-PEEK), titanium, and tantalum.
Pregnancy, or female subject interested in become pregnant during the duration of the study.
Current chemical dependency (e.g., drug and/or alcohol abuse, according to DSM-V definition), as well as those with a history of such abuse.
Uncontrolled depression, psychosis, or other symptoms of a mental disorder that, in the investigator's opinion, likely would make the subject unable to comply with the study procedures and could affect the study outcome.
Treatment with drugs that may interfere with bone metabolism, such as glucocorticosteroids, calcitonin, bisphosphonates, bone therapeutic doses of fluoride, bone therapeutic doses of vitamin D or vitamin D metabolites, and treatment by chemotherapy.
Morbid obesity (BMI ≥ 40).
Current smokers (including 3 months prior to surgery).
Scoliosis, Cobb angle greater than 11°.
Vertebral fractures.
Severe muscular, neural or vascular diseases that endanger the spinal column.
Missing bone structures, due to severely deformed anatomy or congenital anomalies, which make good anchorage of the implant impossible.
Paralysis.
Current use of other investigational drug or device.
The patient is involved in a worker's compensation case or spine-related litigation.
The patient is a prisoner.

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

United States5 sites

Crystal Clinic Orthopaedic Center
Akron, Ohio, 44333
St. David's Round Rock Medical Center
Austin, Texas, 78705
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Brooklyn Hospital
Brooklyn, New York, 11201
Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

Israel3 sites

Herzliya Medical Center
Herzliya, 4685107
Meir Medical Center
Kfar Saba
Assuta Medical Center - Israel Spine Center
Tel Aviv

Other trials in Israel

About this study

Official title: CarboClear Pedicle Screw System

Read the detailed description

A prospective, multi-center, confirmatory, single arm, study. Results of the study will be compared to data from the literature.

The CarboClear Pedicle Screw System is designed for use with intervertebral body fusion device and with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, using PLIF or TLIF.

A total of 55 subjects will participate in the study, with up to 25 patients recruited at sites in Israel and at least 30 patients will be enrolled in US sites.

Follow-ups: Radiographic (AP, lateral and flexion/extension X-Rays) and clinical evaluations.

Follow-up sessions at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively, and then annually, until the last patient has completed 2-year follow-up.

Conditions: Degenerative Disc Disease, Spondylolisthesis, Grade 1
Being tested: Implantation of the CarboClear Pedicle Screw System
Medical subject headings: Intervertebral Disc Degeneration, Spondylolisthesis, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implantation of the CarboClear Pedicle Screw SystemDevice

Study groups in NCT02626624
Study group	Role	What they receive
single arm	Experimental	CarboClear Pedicle Screw System Receives: Device: Implantation of the CarboClear Pedicle Screw System

What is being measured

The primary outcome is the main question the study is designed to answer.

Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab.
Fusion was assessed at follow-up visits, starting at 6 months post operation.
Fusion is defined as:
1. Angular motion ˂ 3º; AND
2. Translational motion ˂ 3 mm; AND
3. Presence of continuous bridging bone between the involved motion segment, i.e.:
- Presence of interbody (between endplates) bridging bone and absence of radiolucency > 50%; OR
- Presence of right posterolateral bridging bone; OR
- Presence of left posterolateral bridging bone.
Measured: 24 months
Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire
Pain was assessed using the Visual Analogue Scale (VAS) preoperatively and at follow-up visits.
The scale ranges from 0 mm ("No Pain") to 100 mm ("Severe Pain"). Patients were instructed to draw a single line across the scale at the point that best described their level of pain.
Pain improvement was evaluated at each location (i.e., low back, right leg, and left leg) and was defined as a reduction of at least 20 mm on a 100 mm VAS from baseline level at 24 months.
Eligible patients experienced preoperative low back and/or leg pain (debilitating pain that significantly disrupted daily physical activities) with a VAS score of ≥40 mm.
Measured: 24 months
Function: Assessed by Oswestry Disability Index (ODI) Patient Questionnaire
The Oswestry Disability Index (ODI) is a patient-reported questionnaire administered preoperatively and at follow-up visits. The ODI consists of ten questions focusing on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Each question has six possible responses.
The response scale ranges from 0 to 5 points, with a lower score indicating better function and lower pain (0 points for full functionality with no or minimal pain; 5 points for inability to perform the function due to pain). The total ODI score is calculated by summing the individual question scores and dividing the total by the maximum possible score (50 if all questions are answered), yielding a percentage. ODI scores range from 0% to 100%, with lower percentages indicating reduced pain and disability.
The functional outcome measure was defined as an improvement of at least 15 points from baseline at 24 months.
Measured: 24 months
Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level.
1. Worsening in neurological status (motor, sensory, reflex, straight leg raising, and tenderness assessments) and no new permanent neurological deficits present for at least 2 successive visits at or beyond 6 months (out to 24 months);
2. Device-related serious adverse events (SAEs) through 24 months;
3. Subsequent surgical interventions at the index level through 24 months.
Measured: Throughout the study until 24 months

Secondary outcomes (4)

Subject's Overall Well-Being: Assessed by 12-Item Short Form Health Survey (SF-12) Patient Questionnaire
Subject's overall well-being (quality of life) was assessed preoperatively and at follow-up visits, using the 12-Item Short Form Health Survey (SF-12), which is a multipurpose short-form quality of life instrument with 12 questions selected from the SF-36 Health Survey. SF-12 questionnaire is designed to measure general health status from the patient's point of view. Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health Scales within the SF-12 instrument. The MCS is a composite of the Vitality, Social Functioning, Role-Emotional and Mental Health Scales within the SF-12 instrument. The SF-12 is a normative based instrument. PCS and MCS are computed using the rating on 12 questions from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level.
Measured: 24 months
Patient Satisfaction: Assessed Based on VAS Patient Questionnaire.
Satisfaction was assessed at postoperative follow-up visits including at 24-month visit, using a 100 mm VAS (the anchor points are "Completely Not Satisfied" (0 mm) and "Completely Satisfied" (100 mm)).
Pain was assessed using the Visual Analogue Scale (VAS) preoperatively and at follow-up visits.
The scale ranges from 0 mm ("No Pain") to 100 mm ("Severe Pain"). Patients were instructed to draw a single line across the scale at the point that best described their level of pain.
Pain improvement was evaluated at each location (i.e., low back, right leg, and left leg) and was defined as a reduction of at least 20 mm on a 100 mm VAS from baseline level at 24 months.
Measured: 24 months
Operation Time [Min]
Operation time (skin-to-skin) was recorded for each subject.
Measured: During operation (skin-to-skin)
Blood Loss During Operation [ml]
The volume of blood loss during operation was recorded for each subject.
Measured: During operation (skin to skin)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 201528 Dec 2022

First posted10 Dec 2015 (estimated)
Study start27 Dec 2015
Primary completion28 Dec 2022
Study completion28 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02626624
Sponsor's protocol ID: CARBOCLEAR P_CLD 2492_US
Status last verified: Apr 2025
First submitted: 30 Nov 2015
Last updated: 27 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CarboClear Pedicle Screw System
ClinicalTrials.gov ID: NCT02626624
Acronym / sponsor ID: CARBOCLEAR P_CLD 2492_US
Conditions: Degenerative Disc Disease, Spondylolisthesis, Grade 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: CarboFix Orthopedics Ltd.Industry (pharma, biotech, devices)
Collaborators: CarboFix Orthopedics Inc.
Study start: 27 Dec 2015 (actual)
Primary completion: 28 Dec 2022 (actual)
Study completion: 28 Dec 2022 (actual)
First posted: 10 Dec 2015 (estimated)
Results: Posted 27 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A prospective, multi-center, confirmatory, single arm, study. Results of the study will be compared to data from the literature.

A total of 55 subjects will participate in the study, with up to 25 patients recruited at sites in Israel and at least 30 patients will be enrolled in US sites.

Follow-ups: Radiographic (AP, lateral and flexion/extension X-Rays) and clinical evaluations.

Follow-up sessions at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively, and then annually, until the last patient has completed 2-year follow-up.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
single arm	Experimental	Device: Implantation of the CarboClear Pedicle Screw SystemCarboClear Pedicle Screw System

Who may qualify

Ages: 21 to 72 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Subject has degenerative disc disease (DDD) at one level, from L2 to S1 vertebrae, with up to Grade I spondylolisthesis.
DDD is defined as back pain and/or radicular leg pain with degeneration of the disc confirmed by patient history, radiographic studies, and physical examination, with one or more of the following factors (as measured radiographically, either by CT, MRI or plain film, myelography, discography, etc.):
Subject is candidate for single level intervertebral fusion, with or without posterolateral fusion, with implantation of intervertebral body fusion device and supplemental fixation.
Subject age is between 21 - 72 years, and subject is skeletally mature.
Pre-operative low back and/or leg/s pain (debilitating pain that causes a significant disturbance of the routine daily physical activities) ≥ 40 mm on a 100 mm Visual Analogue Scale (VAS).

Key exclusion criteria (34 listed)

Previous fusion or fusion attempts, including anterior fusion or posterolateral fusion, at the index level.
Previous fusion or fusion attempts at the adjacent levels.
Prior decompression procedures that include removal of soft and bone tissue at the index or adjacent levels.
Patient is not skeletally mature.
Degenerative spondylolisthesis greater than Grade I.

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
Implantation of the CarboClear Pedicle Screw System	Device	single arm

Primary outcome

Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab.
Time frame: 24 months
Fusion was assessed at follow-up visits, starting at 6 months post operation. Fusion is defined as: 1. Angular motion ˂ 3º; AND 2. Translational motion ˂ 3 mm; AND 3. Presence of continuous bridging bone between the involved motion segment, i.e.: * Presence of interbody (between endplates) bridging bone and absence of radiolucency > 50%; OR * Presence of right posterolateral bridging bone; OR * Presence of left posterolateral bridging bone.
Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire
Time frame: 24 months
Pain was assessed using the Visual Analogue Scale (VAS) preoperatively and at follow-up visits. The scale ranges from 0 mm ("No Pain") to 100 mm ("Severe Pain"). Patients were instructed to draw a single line across the scale at the point that best described their level of pain. Pain improvement was evaluated at each location (i.e., low back, right leg, and left leg) and was defined as a reduction of at least 20 mm on a 100 mm VAS from baseline level at 24 months. Eligible patients experienced preoperative low back and/or leg pain (debilitating pain that significantly disrupted daily physical activities) with a VAS score of ≥40 mm.
Function: Assessed by Oswestry Disability Index (ODI) Patient Questionnaire
Time frame: 24 months
The Oswestry Disability Index (ODI) is a patient-reported questionnaire administered preoperatively and at follow-up visits. The ODI consists of ten questions focusing on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Each question has six possible responses. The response scale ranges from 0 to 5 points, with a lower score indicating better function and lower pain (0 points for full functionality with no or minimal pain; 5 points for inability to perform the function due to pain). The total ODI score is calculated by summing the individual question scores and dividing the total by the maximum possible score (50 if all questions are answered), yielding a percentage. ODI scores range from 0% to 100%, with lower percentages indicating reduced pain and disability. The functional outcome measure was defined as an improvement of at least 15 points from baseline at 24 months.
Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level.
Time frame: Throughout the study until 24 months
1. Worsening in neurological status (motor, sensory, reflex, straight leg raising, and tenderness assessments) and no new permanent neurological deficits present for at least 2 successive visits at or beyond 6 months (out to 24 months); 2. Device-related serious adverse events (SAEs) through 24 months; 3. Subsequent surgical interventions at the index level through 24 months.

4 secondary outcomes

Subject's Overall Well-Being: Assessed by 12-Item Short Form Health Survey (SF-12) Patient Questionnaire
Time frame: 24 months
Patient Satisfaction: Assessed Based on VAS Patient Questionnaire.
Time frame: 24 months
Operation Time [Min]
Time frame: During operation (skin-to-skin)
Blood Loss During Operation [ml]
Time frame: During operation (skin to skin)

Results and safety

Results posted to the registry on 27 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CarboClear Pedicle Screw System (Single Arm Study)	57	47

Primary outcome: Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab.

Time frame: 24 months. Count of participants. Unit: Participants

Measure	CarboClear Pedicle Screw System (Single Arm Study) n = 49
Value	42

Population analysed: 24-month radiographic data is available for 49 patients (for patients that attended the 24-month visit, or for non-attendees for whom data is available from earlier visits (e.g., where fusion was confirmed).

Primary outcome: Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire

Time frame: 24 months. Mean (Standard Deviation). Unit: score on a scale

Measure	CarboClear Pedicle Screw System (Single Arm Study) n = 45
Pain Improvement (VAS) - Low Back	58.52 (31.89)
Pain Improvement (VAS) - Right Leg	58.11 (35.46)
Pain Improvement (VAS) - Left Leg	59.06 (32.99)

Population analysed: VAS pain data is available at 24 months for 45 patients who attended 24-month visit and for whom VAS assessment is available. Analysis is presented for patients with preoperative pain VAS score ≥40 (in accordance with the clinical investigational plan).

Primary outcome: Function: Assessed by Oswestry Disability Index (ODI) Patient Questionnaire

Time frame: 24 months. Mean (Standard Deviation). Unit: score on a scale

Measure	CarboClear Pedicle Screw System (Single Arm Study) n = 45
Value	34.39 (21.43)

Population analysed: Function (ODI) data is available at 24 months for 45 patients who attended 24-month visit and for whom function assessment is available.

Primary outcome: Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level.

Time frame: Throughout the study until 24 months. Count of participants. Unit: Participants

Measure	CarboClear Pedicle Screw System (Single Arm Study) n = 55
Neurological deterioration	3
Device related serious adverse events	0
Subsequent surgical interventions at the index level	4

Population analysed: All subjects that completed the study the study

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Evaluation of complications/adverse events was conducted at each follow-up session, as well as throughout the study (within 24 months).. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CarboClear Pedicle Screw System (Single Arm Study)	7 of 57 (12.3%)	0 of 57 (0%)	2 of 57

Limitations and caveats (from the sponsor): This IDE study encountered a challenging follow-up schedule due to the COVID-19 pandemic. In particular, for several subjects, the 24-month visit occurred during the pandemic period, and was the cause for not attending this visit. On top of quarantine and limitations posed by authorities, a few subjects refused to arrive to hospital during that period.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 34 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, 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?

Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab. (time frame: 24 months). The study lists 4 primary outcomes in all. 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 NCT02626624.

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 27 Apr 2025.