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Novosis Putty for Lumbar Degenerative Disc Disease

This study is looking at the effectiveness and safety of Novosis Putty during transforaminal lumbar interbody fusion (TLIF) surgery for people with lumbar degenerative disc disease. You would either receive Novosis Putty or the standard bone graft during your single-level TLIF surgery. The study aims to see if Novosis Putty leads to overall success, which will be checked 24 months after your surgery. The study is currently recruiting 316 participants between the ages of 21 and 80 who have symptomatic lumbar degeneration confirmed by imaging, with or without certain spinal conditions. The current status of this study is unclear.

Study design
This is a pivotal, randomized, prospective, multi-center study. It plans to enroll 316 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for overall success for 24 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07017634

Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease

Recruiting
PHASE3Ages 21–80InterventionalTreatment
CGBio Inc.
~316 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Novosis PuttyStandard of Care

At a glance

Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Success
Measured over 24 months after surgery

Conditions

Degenerative Disc Disease

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NCT07017634

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • American Neurospine Institute, PLLC

    Frisco, Texasstudy coordinator listed

    Recruiting

  • LSU Health

    Shreveport, Louisianastudy coordinator listed

    Recruiting

  • Paradigm Health System / Sterling Surgical Hospital

    Slidell, Louisianastudy coordinator listed

    Not yet recruiting

  • The Ohio State University

    Dublin, Ohiostudy coordinator listed

    Not yet recruiting

  • The Spine Center of Louisiana

    Baton Rouge, Louisianastudy coordinator listed

    Recruiting

  • Thomas Jefferson University - Department of Neurological Surgery

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • UC Davis

    Sacramento, Californiastudy coordinator listed

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Jumi Han
[email protected]
1.949.445.5965
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Overall Success24 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