NCT07017634

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: CGBio Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Novosis Putty	Single Level TLIF surgery with Novosis Putty
OTHER	Standard of Care	Single Level TLIF surgery with standard of care bone graft

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-12-01
• Completion: 2031-11-01
• First posted: 2025-06-12
• Last updated: 2026-02-20

Regulatory

• FDA-regulated device study