NCT03810573

Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety And Preliminary Effectiveness Of NB1 Bone Graft In Subjects With Degenerative Disc Disease Undergoing Transforaminal Lumbar Interbody Fusion

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Bone Biologics Corp · Industry
• Sex: All
• Age: 17 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion. It is estimated that up to 30 participants will be enrolled in approximately 3 clinical sites. During baseline and follow-up assessments, patients will be asked to undergo x-rays and CT scans; adverse events and immunology will be collected, and; participants will be requested to complete participant questionnaires regarding quality of life, pain and function.

Conditions

• Degenerative Disc Disease
• Spondylolisthesis

Interventions

Type	Name	Description
DEVICE	NB1	rhNELL-1/DBX

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2019-01-18
• Last updated: 2024-03-12

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated device study