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Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Sponsor
Bone Biologics Corp (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT03810573
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
25
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NB1
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

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

Autograft

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Monash Medical Center Clayton Victoria Australia 3168

Sponsors and Collaborators

  • Bone Biologics Corp

Investigators

  • Principal Investigator: Tony Goldschlager, MD, Monash Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bone Biologics Corp
ClinicalTrials.gov Identifier:
NCT03810573
Other Study ID Numbers:
  • NB1-100
First Posted:
Jan 18, 2019
Last Update Posted:
Mar 3, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spondylolisthesis

Study Results

No Results Posted as of Mar 3, 2022