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Recruiting Phase 3

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

NCT07017634 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 3
Started
2026-06-11
Last updated
2026-08-26

Condition(s) studied

Degenerative Disc Disease

Investigational drug(s) / intervention(s)

Novosis PuttyStandard of Care

Novosis Putty: Single Level TLIF surgery with Novosis Putty

Standard of Care: Single Level TLIF surgery with standard of care bone graft

Study 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

Eligibility

Sex
ALL
Min age
21 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • Overall Success — 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

Trial sites (10)

FacilityCityRegionStatus
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
UC Davis Sacramento California Recruiting
University of Miami Miami Florida Recruiting
The Spine Center of Louisiana Baton Rouge Louisiana Recruiting
LSU Health Shreveport Louisiana Recruiting
Paradigm Health System / Sterling Surgical Hospital Slidell Louisiana Not Yet Recruiting
The Ohio State University Dublin Ohio Not Yet Recruiting
Thomas Jefferson University - Department of Neurological Surgery Philadelphia Pennsylvania Recruiting
American Neurospine Institute, PLLC Frisco Texas Recruiting
West Virginia University - Department of Orthopaedics Morgantown West Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07017634 on ClinicalTrials.gov ↗ ← All trials in the USA