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)
Facility
City
Region
Status
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.
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