Efficacy and Safety of NOVOSIS Putty for Interbody Lumbar Fusion Cases

NCT ID: NCT07017634

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2031-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Novosis Putty

Group Type: EXPERIMENTAL

Novosis Putty

Intervention Type: DEVICE

Single Level TLIF surgery with Novosis Putty

Standard of Care

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Single Level TLIF surgery with standard of care bone graft

Interventions

Novosis Putty

Single Level TLIF surgery with Novosis Putty

Intervention Type: DEVICE

Standard of Care

Single Level TLIF surgery with standard of care bone graft

Intervention Type: OTHER

Eligibility Criteria

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 preoperative Oswestry Disability Index score ≥ 40/100 at baseline
• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CGBio USA

UNKNOWN

Sponsor Role: collaborator

CGBio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jumi Han

Role: CONTACT

Jumi.Han@CGBioUSA.com

1.949.445.5965

Other Identifiers

CGNVP002

Identifier Type: -

Identifier Source: org_study_id