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
1 other identifier
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2024
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2019
CompletedFirst Posted
Study publicly available on registry
January 18, 2019
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedMarch 12, 2024
March 1, 2024
1.3 years
January 17, 2019
March 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Removal, revision, or supplemental fixation
12 months
Study Arms (3)
NB1-1.5
EXPERIMENTALNB1 low dose
NB1-2.0
EXPERIMENTALNB1 high dose
Autograft
NO INTERVENTIONAutograft
Interventions
Eligibility Criteria
You may qualify if:
- Documented diagnosis of degenerative disc disease
- Up to Grade I spondylolisthesis
- Eligible to undergo a single vertebral level spine fusion (L2 to S1)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Monash Medical Center
Clayton, Victoria, 3168, Australia
St Vincent Melbourne
Fitzroy, Australia
St George Hospital
Kogarah, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tony Goldschlager, MD
Monash Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2019
First Posted
January 18, 2019
Study Start
March 1, 2024
Primary Completion
June 1, 2025
Study Completion
June 1, 2026
Last Updated
March 12, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
As requested