Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Launched by BONE BIOLOGICS CORP · Jan 17, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called NB1 Bone Graft for patients with degenerative disc disease and mild spinal instability known as spondylolisthesis. The study aims to find out if this bone graft is safe and effective for helping patients who need spinal surgery called transforaminal lumbar interbody fusion. About 30 participants will be involved across three different locations, and they will undergo tests like x-rays and CT scans to monitor their progress. Participants will also answer questions about their pain, daily activities, and overall quality of life.

To be eligible for the trial, participants must have a confirmed diagnosis of degenerative disc disease and mild spondylolisthesis, and they should be able to have surgery at a single level of their spine (from the lower back, L2 to S1). However, those who have had previous spinal surgery at that level or have more severe spondylolisthesis will not qualify. As participants, you can expect to have regular check-ups, and the study will keep track of any side effects that may occur during the trial. This research could help improve treatment options for people with similar spine conditions in the future.

Gender

ALL

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