Back to resultsEvaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Primary Purpose
Degenerative Disc Disease, Spondylolisthesis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
NB1
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease
Eligibility Criteria
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
Sites / Locations
- Monash Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
NB1-1.5
NB1-2.0
Autograft
Arm Description
NB1 low dose
NB1 high dose
Autograft
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03810573
Brief Title
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bone Biologics Corp
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Spondylolisthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NB1-1.5
Arm Type
Experimental
Arm Description
NB1 low dose
Arm Title
NB1-2.0
Arm Type
Experimental
Arm Description
NB1 high dose
Arm Title
Autograft
Arm Type
No Intervention
Arm Description
Autograft
Intervention Type
Device
Intervention Name(s)
NB1
Intervention Description
rhNELL-1/DBX
Primary Outcome Measure Information:
Title
Fusion
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Removal, revision, or supplemental fixation
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brent Atkinson, PhD
Phone
13035507866
Email
atkinsonbrent520@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Goldschlager, MD
Organizational Affiliation
Monash Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monash Medical Center
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Goldschlager, MD
First Name & Middle Initial & Last Name & Degree
Tony Goldschlager, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
As requested
Learn more about this trial
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
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