Novosis Putty used with transforaminal lumbar interbody fusion for lumbar degenerative disc disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pivotal, randomized, prospective, multi-center Phase 3 trial compares Novosis Putty to standard of care when used as an adjunct during transforaminal lumbar interbody fusion (TLIF) in adults with degenerative disc disease. Eligible patients are randomized at participating U.S. centers and followed for clinical and radiographic outcomes, including fusion status, safety events, and disability measured by the Oswestry Disability Index. The study enrolls adults 21–80 with symptomatic lumbar degeneration who have failed at least six months of conservative therapy and have baseline ODI ≥40 and no more than Grade 2 spondylolisthesis. Imaging and patient-reported outcomes are collected at scheduled postoperative visits to determine if Novosis Putty improves fusion rates and functional recovery compared with standard treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• UC Davis
  Sacramento, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• The Spine Center of Louisiana
  Baton Rouge, Louisiana, United States Recruiting
• LSU Health
  Shreveport, Louisiana, United States Recruiting
• Thomas Jefferson University - Department of Neurological Surgery
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Jumi Han
• Email: Jumi.Han@CGBioUSA.com
• Phone: 1.949.445.5965

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.