Trials / Completed
CompletedNCT03884283
Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT
A Post-market, Prospective, Multi-center, Nonrandomized Study to Assess Posterolateral Lumbar Fusions Using FIBERGRAFT BG Matrix
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Prosidyan, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FIBERGRAFT BG Matrix | 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) |
Timeline
- Start date
- 2019-02-19
- Primary completion
- 2023-05-21
- Completion
- 2023-05-21
- First posted
- 2019-03-21
- Last updated
- 2024-04-22
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03884283. Inclusion in this directory is not an endorsement.