rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

NCT03527966 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB G17008
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Postoperative Leg/Back Pain Score

  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

Study Arms (2)

Intervention group - 5cc Vivigen and local autograft

ACTIVE COMPARATOR

Biological: 5cc Vivigen and local autograft

Control group - small kit rhBMP-2 with local autograft

ACTIVE COMPARATOR

Biological: Small kit rhBMP-2 with local autograft

Interventions

5cc Vivigen and local autograft BIOLOGICAL

The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft

Intervention group - 5cc Vivigen and local autograft

Small kit rhBMP-2 with local autograft BIOLOGICAL

The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft

Control group - small kit rhBMP-2 with local autograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older;
• 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;
• Willing to provide informed consent, participate in study, and comply with study protocol.

You may not qualify if:

• Pregnant or contemplating pregnancy prior to surgery;
• Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
• Surgery involving more than 2 vertebral levels;
• 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).
• Lactating women
• Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin
• Immune compromised patients

Sponsors & Collaborators

• Virtua Health, Inc.: lead

Study Sites (1)

Virtua Memorial Hospital

Mount Holly, New Jersey, 08060, United States

Location

Results Point of Contact

• Title: Jillian Hoopes
• Organization: Virtua Health Inc.

jhoopes@virtua.org

856-761-3904

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The surgical team, including the surgeons, will be blinded to the treatment options until decompression/instrumentation have been completed. The patients and all staff, including hospital nursing staff, case management, and physical therapists, will be blinded as to which bone graft treatment the patient received.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 17, 2018
• Study Start: July 3, 2017
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)