NCT03527966

rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Virtua Health, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Lumbar Spine Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	5cc Vivigen and local autograft	The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
BIOLOGICAL	Small kit rhBMP-2 with local autograft	The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft

Timeline

• Start date: 2017-07-03
• Primary completion: 2018-07-27
• Completion: 2018-07-27
• First posted: 2018-05-17
• Last updated: 2019-08-28
• Results posted: 2019-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study