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
CGBio Inc.
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
- Age range
- 21–80 years
- Sex
- All
- 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 preoperati…
Interventions
- DeviceNovosis Putty
Single Level TLIF surgery with Novosis Putty
- OtherStandard of Care
Single Level TLIF surgery with standard of care bone graft
Locations (5)
- The Spine Center of LouisianaBaton Rouge, Louisiana
- LSU HealthShreveport, Louisiana
- Thomas Jefferson University - Department of Neurological SurgeryPhiladelphia, Pennsylvania
- American Neurospine Institute, PLLCFrisco, Texas
- West Virginia University - Department of OrthopaedicsMorgantown, West Virginia