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

NCT07017634 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

DEVICE

Novosis Putty

Single Level TLIF surgery with Novosis Putty

OTHER

Standard of Care

Single Level TLIF surgery with standard of care bone graft

Sponsors & Collaborators

  • CGBio USA

    collaborator UNKNOWN

  • CGBio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-12-31
Completion
2031-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07017634 on ClinicalTrials.gov