Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease
Purpose
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
Condition
- Degenerative Disc Disease
Eligibility
- Eligible Ages
- Between 21 Years and 80 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Novosis Putty |
|
|
|
Active Comparator Standard of Care |
|
Recruiting Locations
The Spine Center of Louisiana
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
LSU Health
Shreveport, Louisiana 71101
Shreveport, Louisiana 71101
Thomas Jefferson University - Department of Neurological Surgery
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
American Neurospine Institute, PLLC
Frisco, Texas 75034
Frisco, Texas 75034
West Virginia University - Department of Orthopaedics
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
More Details
- NCT ID
- NCT07017634
- Status
- Recruiting
- Sponsor
- CGBio Inc.