This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft and bone marrow aspirate 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
102
Subjects who meet the criteria for entrance into the study will undergo posterolateral fusion using FIBERGRAFT® BG Matrix in combination with autograft and bone marrow aspirate (BMA)
Long Beach Medical Center
Long Beach, California, United States
Memorial Orthopaedic Surgical Group
Long Beach, California, United States
Palm Beach Neurosurgery
Wellington, Florida, United States
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States
Washington Spine & Scoliosis Institute at OrthoBethesda
Bethesda, Maryland, United States
Northwell Health Orthopaedic Institute
Great Neck, New York, United States
KeiperSpine, PC
Eugene, Oregon, United States
Orthopedic and Neurologic Research Institute
Fort Worth, Texas, United States
University of Virginia Orthopaedics
Charlottesville, Virginia, United States
Spinal fusion
Spinal fusion will be determined via radiographic imaging at 12 months.
Time frame: 12 months
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