Trial Number
951-19
Condition
Degenerative disk disease
Participant Age Range
18 years and older
Participant Gender
Any
Enrolling Participants
Yes
Overview
“A Post-Market, Prospective, Mutli-Center, Nonrandomized Study to Assess Posterolateral Lumbar Fusions using Fibergraft® BG Matrix”
This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed in up to 150 subjects with degenerative disc disease (DDD) with or without radiculopathy, or spinal stenosis and/or spondylolisthesis requiring a fusion. The patient population will include adult (skeletally mature) men and women undergoing 1 or 2 level fusion in the lumbar spine (L2-S1) who are deemed eligible for the study, characterized by inclusion and exclusion criteria.