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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIBERGRAFT BG Matrix | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal fusion | Spinal fusion will be determined via radiographic imaging at 12 months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Medical Center | Long Beach | California | 90806 | United States | ||
| Memorial Orthopaedic Surgical Group |
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| Long Beach |
| California |
| 90806 |
| United States |
| Palm Beach Neurosurgery | Wellington | Florida | 33449 | United States |
| Orthopaedic Institute of Western Kentucky | Paducah | Kentucky | 42001 | United States |
| Washington Spine & Scoliosis Institute at OrthoBethesda | Bethesda | Maryland | 20817 | United States |
| Northwell Health Orthopaedic Institute | Great Neck | New York | 11021 | United States |
| KeiperSpine, PC | Eugene | Oregon | 97401 | United States |
| Orthopedic and Neurologic Research Institute | Fort Worth | Texas | 76132 | United States |
| University of Virginia Orthopaedics | Charlottesville | Virginia | 22903 | United States |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
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