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rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

2018-05-22 18:49:10 | BioPortfolio

Summary

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.

Description

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

Study Design

Conditions

Lumbar Spine Degeneration

Intervention

5cc Vivigen and local autograft, Small kit rhBMP-2 with local autograft

Location

Virtua Memorial Hospital
Mount Holly
New Jersey
United States
08060

Status

Recruiting

Source

Virtua Health, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-05-22T18:49:10-0400

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