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Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Sponsor: Bone Biologics Corp
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.
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
Key Details
Gender
All
Age Range
17 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-03-01
Completion Date
2026-06-01
Last Updated
2024-03-12
Healthy Volunteers
No
Interventions
NB1
rhNELL-1/DBX
Locations (3)
Monash Medical Center
Clayton, Victoria, Australia
St Vincent Melbourne
Fitzroy, Australia
St George Hospital
Kogarah, Australia