Actively Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Led by Bone Biologics Corp · Updated on 2024-03-12
30
Participants Needed
3
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of degenerative disc disease
- Up to Grade I spondylolisthesis
- Eligible to undergo a single vertebral level spine fusion (L2 to S1)
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Monash Medical Center
Clayton, Victoria, Australia, 3168
Actively Recruiting
2
St Vincent Melbourne
Fitzroy, Australia
Actively Recruiting
3
St George Hospital
Kogarah, Australia
Actively Recruiting
Research Team
B
Brent Atkinson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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