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

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.

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