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This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.
The purpose of this study is to compare the overall efficacy (clinical outcome and radiographic fusion) of Vivigen (cellular allograft product) and rhBMP-2 in patients who undergo a single level lumbar instrumented fusion. Specifically, when compared to their control group counterparts treated to rhBMP-2, we hypothesize that the intervention group administered Vivigen would, following surgery, experience:
2. Comparable inpatient length of stay (LOS)
3. Comparable postoperative Oswestry Disability Index (ODI) score (0-no disability, to 100-maximum disability possible), two weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively
4. Comparable fusion rates, evaluated via CT scan I year postoperatively
Lumbar Spine Degeneration
5cc Vivigen and local autograft, Small kit rhBMP-2 with local autograft
Virtua Memorial Hospital
Virtua Health, Inc.
Published on BioPortfolio: 2018-05-22T18:49:10-0400
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