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

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Spondylolisthesis
• Intervention / Treatment: Device: NB1

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brent Atkinson, PhD; Phone Number: 13035507866; Email: atkinsonbrent520@gmail.com

Study Locations

• Australia
  • Fitzroy, Australia
    • Recruiting
    • St Vincent Melbourne
    • Contact: Terence Tan
    • Principal Investigator: Ternece Tan, MD
  • Kogarah, Australia
    • Recruiting
    • St George Hospital
    • Contact: Ashish Diwan
    • Principal Investigator: Ashish Diwan, MD
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Medical Center
      • Principal Investigator: Tony Goldschlager, MD
      • Contact: Tony Goldschlager, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NB1-1.5; NB1 low dose	Device: NB1; rhNELL-1/DBX
Experimental: NB1-2.0; NB1 high dose	Device: NB1; rhNELL-1/DBX
No Intervention: Autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bone Biologics Corp
• Investigators: Principal Investigator: Tony Goldschlager, MD, Monash Health

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: NB1-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As requested
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes