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RECRUITING
NCT03810573
NA

Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Sponsor: Bone Biologics Corp

View on ClinicalTrials.gov

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

DEVICE

NB1

rhNELL-1/DBX

Locations (3)

Monash Medical Center

Clayton, Victoria, Australia

St Vincent Melbourne

Fitzroy, Australia

St George Hospital

Kogarah, Australia