Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03810573
• Other study ID #: NB1-100
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: March 2024
• Source: Bone Biologics Corp
• Contact: Brent Atkinson, PhD
• Phone: 13035507866
• Email: atkinsonbrent520[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spondylolisthesis

Intervention

Device:
• NB1
rhNELL-1/DBX

Locations

Country	Name	City	State
Australia	Monash Medical Center	Clayton	Victoria
Australia	St Vincent Melbourne	Fitzroy
Australia	St George Hospital	Kogarah

Sponsors (1)

Lead Sponsor	Collaborator
Bone Biologics Corp

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion	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	12 months
Secondary	Removal, revision, or supplemental fixation	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	12 months