NCT06715345

Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease

Sponsor-initiated Clinical Study to Evaluate the Efficacy and Safety of Novosis Putty for Bone Fusion in Patients Requiring Posterior Instrumentation and Transforaminal Lumbar Interbody Fusion Due to Degenerative Lumbar Disease

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: CGBio Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical study aims to evaluate the efficacy and safety of NOVOSIS PUTTY for bone fusion in patients requiring posterior instrumentation and transforaminal lumbar interbody fusion (TLIF) due to degenerative lumbar disease.

Detailed description

The Subject is a patient requiring posterior instrumentation and transforaminal lumbar interbody fusion (TLIF) due to degenerative lumbar disease. This clinical study aims to compare and evaluate the efficacy and safety of three dose groups of NOVOSIS PUTTY for bone fusion compared to the autologous bone in patients requiring posterior instrumentation and TLIF in the single level between L2 and S1(L2-S1) due to degenerative lumbar disease. * Control Group (n=12): Local autologous bone * Experimental Group 1 (n=12): Dose 1 * Experimental Group 2 (n=12): Dose 2 * Experimental Group 3 (n=12): Dose 3

Conditions

• Degenerative Lumbar Diseases

Interventions

Type	Name	Description
DEVICE	Bone graft materials and rhBMP-2	NOVOSIS PUTTY is a product composed of recombinant human bone morphogenetic protein-2 and β-tricalcium phosphate/hydrogel complex.

Timeline

• Start date: 2024-03-06
• Primary completion: 2024-06-30
• Completion: 2025-12-31
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: South Korea