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rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

NCT03527966 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-08-28

Study results available
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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.

Conditions

  • Lumbar Spine Degeneration

Interventions

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

Sponsors & Collaborators

  • Virtua Health, Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-03
Primary Completion
2018-07-27
Completion
2018-07-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03527966 on ClinicalTrials.gov