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

Recruiting now · Phase 3

Conditions studied: Degenerative Disc Disease

In brief

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

Key facts

Study ID

NCT07017634

Run by

CGBio Inc.

People needed

316

Starts

2026-05-01

Expected to finish

2031-11-01

Last updated by the study team

2026-05-08

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Spine Center of Louisiana — Baton Rouge, Louisiana, United States (enrolling)
• LSU Health — Shreveport, Louisiana, United States (enrolling)
• Thomas Jefferson University - Department of Neurological Surgery — Philadelphia, Pennsylvania, United States (enrolling)
• American Neurospine Institute, PLLC — Frisco, Texas, United States (enrolling)
• West Virginia University - Department of Orthopaedics — Morgantown, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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