Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Not Applicable

Recruiting

• Conditions: Degenerative Disc Disease; Spondylolisthesis
• Interventions: Device: NB1

• Registration Number: NCT03810573
• Lead Sponsor: Bone Biologics Corp

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Documented diagnosis of degenerative disc disease
• Up to Grade I spondylolisthesis
• Eligible to undergo a single vertebral level spine fusion (L2 to S1)

Exclusion Criteria

• Previous spinal instrumentation or previous interbody fusion procedure at the involved level
• Grade II or greater spondylolisthesis
• Systemic or local infection at the site of surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NB1-2.0	NB1	NB1 high dose
NB1-1.5	NB1	NB1 low dose

Primary Outcome Measures

Name	Time	Method
Fusion	12 months	Defined by an independent (blinded to treatment) radiological assessment as less than five degrees angular vertebral motion, less than three millimeters of translational movement and evidence of bridging bone between the involved vertebral endplates based on x-rays at 12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Removal, revision, or supplemental fixation	12 months	Whether there was removal, revision or supplemental fixation of the graft material that required reoperation at the index level during the follow-up period of the study

Trial Locations

Locations (3)

St Vincent Melbourne; 🇦🇺 Fitzroy, Australia

Monash Medical Center; 🇦🇺 Clayton, Victoria, Australia

St George Hospital; 🇦🇺 Kogarah, Australia