Recruiting
Phase 3
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease
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
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 |
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