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

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.

Study Overview

• Status: Terminated
• Conditions: Lumbar Spine Degeneration
• Intervention / Treatment: Biological: 5cc Vivigen and local autograft; Biological: Small kit rhBMP-2 with local autograft

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

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Mount Holly, New Jersey, United States, 08060
      • Virtua Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 or older;
2. Diagnosed with lumbar degenerative/isthmic spondylolisthesis, degenerative disc disease with axial low back pain and neurologic symptoms, failed conservative treatment and eligible for a single level lumbar instrumented fusion;
3. Willing to provide informed consent, participate in study, and comply with study protocol.

Exclusion Criteria:

1. Pregnant or contemplating pregnancy prior to surgery;
2. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
3. Surgery involving more than 2 vertebral levels;
4. Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests; could also run into potential issues with reimbursement).
5. Lactating women
6. Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin
7. Immune compromised patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention group - 5cc Vivigen and local autograft	Biological: 5cc Vivigen and local autograft; The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
ACTIVE_COMPARATOR: Control group - small kit rhBMP-2 with 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Oswestry Disability Index (ODI) Score	The ODI is one of the most commonly utilized condition-specific measures of disability used in the management of spinal disorders (0-no disability, to 100-maximum disability possible)	Up to 1 year post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Postoperative Leg/Back Pain Score	Pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible	Average of 3 days in hospital
Mean Inpatient Length of Stay		Average of 3 days in hospital
Fusion Rates, Evaluated Via CT Scan I Year Postoperatively		1 year post surgery

Collaborators and Investigators

• Sponsor: Virtua Health, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 3, 2017
• Primary Completion (ACTUAL): July 27, 2018
• Study Completion (ACTUAL): July 27, 2018

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (ACTUAL): May 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB G17008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Plan to disseminate study findings via conference representation and journal publication using de-identified analyzed data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes