Actively Recruiting
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease
Led by CGBio Inc. · Updated on 2026-05-08
316
Participants Needed
5
Research Sites
287 weeks
Total Duration
On this page
Sponsors
C
CGBio Inc.
Lead Sponsor
C
CGBio USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis confirmed by history and imaging
- No more than Grade 2 (≤50% translation) spondylolisthesis
- History of failed conservative treatment for at least 6 months
- Preoperative Oswestry Disability Index score of 40 or higher
- Male or female aged 21 to 80 years, skeletally mature
- Mentally and physically able to comply with study protocol and follow-up
- Signed informed consent
You will not qualify if you...
- Previous instrumented surgery at the index or adjacent lumbar level
- Degenerative or lytic spondylolisthesis greater than Grade 2 (50% translation)
- Active invasive malignancy or history of malignancy within past 5 years (except non-melanoma skin cancer)
- Degenerative muscular or neurological conditions interfering with outcome evaluation (e.g., Parkinson's disease, ALS, multiple sclerosis)
- Chronic or acute kidney or liver impairment or history of related diseases
- Lactating, pregnant, or planning pregnancy within 3 years
- Participating in another investigational therapy within 30 days prior to study or during 24 months after enrollment
- Known allergy or hypersensitivity to study treatment components including BMP-2 proteins or peptides
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The Spine Center of Louisiana
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
2
LSU Health
Shreveport, Louisiana, United States, 71101
Actively Recruiting
3
Thomas Jefferson University - Department of Neurological Surgery
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
4
American Neurospine Institute, PLLC
Frisco, Texas, United States, 75034
Actively Recruiting
5
West Virginia University - Department of Orthopaedics
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
J
Jumi Han
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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