RecruitingPhase 3NCT07017634

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

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

Sponsor

CGBio Inc.

Enrollment

316 participants

Start Date

Jun 11, 2026

Study Type

INTERVENTIONAL

Conditions

Degenerative Disc Disease

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

Min Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Novosis Putty and Standard of Care for people with degenerative disc disease. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 21 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENovosis Putty

Single Level TLIF surgery with Novosis Putty

OTHERStandard of Care

Single Level TLIF surgery with standard of care bone graft

Locations(10)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

UC Davis

Sacramento, California, United States

University of Miami

Miami, Florida, United States

The Spine Center of Louisiana

Baton Rouge, Louisiana, United States

LSU Health

Shreveport, Louisiana, United States

Paradigm Health System / Sterling Surgical Hospital

Slidell, Louisiana, United States

The Ohio State University

Dublin, Ohio, United States

Thomas Jefferson University - Department of Neurological Surgery

Philadelphia, Pennsylvania, United States

American Neurospine Institute, PLLC

Frisco, Texas, United States

West Virginia University - Department of Orthopaedics

Morgantown, West Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07017634

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