Lumbar Spine Degeneration Clinical Trial
Official title:
rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study
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:
1. Comparable mean postoperative leg/back pain score, where the pain scores are obtained
using the numeric rating scale of 0-no pain, to 10-worst pain possible
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
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