Degenerative Disc DiseasePhase 3NCT07017634
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease
A Phase 3 study testing Novosis Putty in people with Degenerative Disc Disease, run by CGBio Inc. at 10 sites in United States.
Trial summary
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Novosis Putty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 10 sitesUnited States
- Study dates
- 11 Jun 2026to Nov 2031
- Phase
- Phase 3
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 2 (≤50% translation) spondylolisthesis. Symptomatic lumbar degeneration (L1 to S1) that may be associated with a co-morbid condition.
- Has a history of failure conservative treatment (e.g. bed rest, physical therapy, medications, transcutaneous electrical nerve stimulation (TENS), manipulation, and/or spinal injections) for at least 6 months
- Has preoperative Oswestry Disability Index score ≥ 40/100 at baseline
- Male or Female, 21-80 years of age and skeletally mature at the time of surgery
- Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms
- Signed informed consent
Who cannot join
- Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
- Degenerative or lytic spondylolisthesis greater than Grade 2 (50% translation);
- Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
- Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis;
- Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease;
- Lactating, pregnant or interested in becoming pregnant in the next 3 years;
- Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.
- Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
The Spine Center of Louisiana
Baton Rouge, Louisiana, 70809
Ana Heully, 225-515-5700 ext. 1047, aheully@saon.net
Heather Bowman
- Not yet recruiting
The Ohio State University
Dublin, Ohio, 43016
Allison Garvin, 614-688-8304, allison.garvin@osumc.edu
Allison Reynolds
- Recruiting
American Neurospine Institute, PLLC
Frisco, Texas, 75034
Gladcy Mathew, 469-989-3768, Gladcy.Mathew@hcahealthcare.com
Ezioma Akwara
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Dana L. Garrison, 501-231-1193, DLGarrison@UAMS.edu
Kennetha Newman
- Recruiting
University of Miami
Miami, Florida, 33136
Yamilet Nieves Vega, 305-243-5998, yxn176@med.miami.edu
Adriana Saravia
- Recruiting
West Virginia University - Department of Orthopaedics
Morgantown, West Virginia, 26506
Jennifer Eicher, 304-293-2485, jeicher@hsc.wvu.edu
Monica Maxwell
- Recruiting
Thomas Jefferson University - Department of Neurological Surgery
Philadelphia, Pennsylvania, 19107
Mary Gomez, 215-503-4852, mary.gomez@jefferson.edu
Sha'Mere Herder
- Recruiting
UC Davis
Sacramento, California, 95816
Melanie Ann Peters, 916-734-2756, melpeters@health.ucdavis.edu
Savina Nguyen
- Recruiting
LSU Health
Shreveport, Louisiana, 71101
Saraith Bernard, 281-236-8492, saraith.bernard@lsuhs.edu
Jessica Paul
- Not yet recruiting
Paradigm Health System / Sterling Surgical Hospital
Slidell, Louisiana, 70809
Christopher Minnerly, 305-394-7734, cminnerly@paradigmhealth.net
Zachary Dodd, MD
About this study
Official title: Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study
- Conditions
- Degenerative Disc Disease
- Being tested
- Novosis Putty, Standard of Care
- 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.
Novosis PuttyDevice
Single Level TLIF surgery with Novosis Putty
Standard of CareOther
Single Level TLIF surgery with standard of care bone graft
| Study group | Role | What they receive |
|---|---|---|
| Novosis Putty | Experimental | Not described Receives: Device: Novosis Putty |
| Standard of Care | Active comparator | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Success
Meet all of the following conditions:
- Fusion success
- Oswestry Disability Index success
- Neurological success
- No subsequent surgical interventions
- No related serious event
Measured: 24 months after surgery
Secondary outcomes (10)
Fusion Success
Fusion Success at Month 12 via CT scan and X-ray defined by the success of the 3 components: Interbody Bridging Bone from the superior to the inferior vertebral body (via CT), Angular Motion ≤ 5° (via X-ray) AND Translational Motion ≤ 3 mm at the index level (via X-ray).
Secondary categorical endpoints will be summarized over time using counts and percentages.
Measured: 12 months after surgery
Overall Success
Meet all of the following conditions:
- Fusion success
- Oswestry Disability Index success
- Neurological success
- No subsequent surgical interventions
- No related serious event
Measured: 6 and 12 months after surgery
Fusion Success
Fusion Success at Month 6 and Month 24 via CT scan and X-ray defined by the success of the 3 components: Interbody Bridging Bone from the superior to the inferior vertebral body (via CT), Angular Motion ≤ 5° (via X-ray) AND Translational Motion ≤ 3 mm at the index level (via X-ray). Secondary categorical endpoints will be summarized over time using counts and percentages.
Measured: 6 and 24 months after surgery
ODI score
Evaluate Oswestry Disability Index(ODI) score/ lowest 0(best) to highest 100(worst)
Measured: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
VAS score
Evaluate Visual Analog Scale(VAS) score/ none (0 mm) to an extreme amount of pain (100mm)
Measured: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
SF-12 score
Evaluate SF-12 scores / lowest 0(worst) to highest 100(best)
Measured: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
Time to Fusion Success
Measured: From surgery to 60 months after surgery
Time to First SSI
Measured: From surgery to 60 months after surgery
Treatment satisfaction
Measured: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
Intraoperative variables
Surgery time, blood loss
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start11 Jun 2026
- Primary completionDec 2028 (estimated)
- Study completionNov 2031 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CGBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CGBio USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017634
- Sponsor's protocol ID
- CGNVP002
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study
- ClinicalTrials.gov ID
- NCT07017634
- Acronym / sponsor ID
- CGNVP002
- Conditions
- Degenerative Disc Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- CGBio Inc.Industry (pharma, biotech, devices)
- Collaborators
- CGBio USA
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 12 Jun 2025 (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.
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novosis Putty | Experimental | Device: Novosis Putty |
| Standard of Care | Active comparator | Other: Standard of Care |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 2 (≤50% translation) spondylolisthesis. Symptomatic lumbar degeneration (L1 to S1) that may be associated with a co-morbid condition.
- Has a history of failure conservative treatment (e.g. bed rest, physical therapy, medications, transcutaneous electrical nerve stimulation (TENS), manipulation, and/or spinal injections) for at least 6 months
- Has preoperative Oswestry Disability Index score ≥ 40/100 at baseline
- Male or Female, 21-80 years of age and skeletally mature at the time of surgery
- Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms
Key exclusion criteria (8 listed)
- Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
- Degenerative or lytic spondylolisthesis greater than Grade 2 (50% translation);
- Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
- Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis;
- Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease;
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 |
|---|---|---|
| Novosis PuttySingle Level TLIF surgery with Novosis Putty | Device | Novosis Putty |
| Standard of CareSingle Level TLIF surgery with standard of care bone graft | Other | Standard of Care |
Primary outcome
Overall Success
Time frame: 24 months after surgery
Meet all of the following conditions: 1. Fusion success 2. Oswestry Disability Index success 3. Neurological success 4. No subsequent surgical interventions 5. No related serious event
10 secondary outcomes
Fusion Success
Time frame: 12 months after surgery
Overall Success
Time frame: 6 and 12 months after surgery
Fusion Success
Time frame: 6 and 24 months after surgery
ODI score
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
VAS score
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
SF-12 score
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
Time to Fusion Success
Time frame: From surgery to 60 months after surgery
Time to First SSI
Time frame: From surgery to 60 months after surgery
Treatment satisfaction
Time frame: 6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery
Intraoperative variables
Time frame: intraoperative
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 26 Aug 2026.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Novosis Putty in people with Degenerative Disc Disease, run by CGBio Inc. at 10 sites in United States.
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 6 inclusion and 8 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jumi Han (1.949.445.5965, Jumi.Han@CGBioUSA.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Success (time frame: 24 months after surgery). 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 26 Aug 2026.