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

NCT07017634 | Not Yet Recruiting Phase 3 FDA Device

• 1 other identifier: CGNVP002
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Overall Success

  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

  24 months after surgery

Secondary Outcomes (10)

• Fusion Success

  12 months after surgery

• Overall Success

  6 and 12 months after surgery

• Fusion Success

  6 and 24 months after surgery

• ODI score

  6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery

• VAS score

  6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery

Study Arms (2)

Novosis Putty

EXPERIMENTAL

Device: Novosis Putty

Standard of Care

ACTIVE COMPARATOR

Other: Standard of Care

Interventions

Standard of Care OTHER

Single Level TLIF surgery with standard of care bone graft

Standard of Care

Novosis Putty DEVICE

Single Level TLIF surgery with Novosis Putty

Novosis Putty

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CGBio Inc.: lead
• CGBio USA: collaborator

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jumi Han

CONTACT

1.949.445.5965; Jumi.Han@CGBioUSA.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): November 1, 2031
• Last Updated: February 20, 2026

Record last verified: 2026-02