rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

• ClinicalTrials.gov Identifier: NCT03527966
• Recruitment Status: Terminated
• First Posted: May 17, 2018
• Results First Posted: August 7, 2019
• Last Update Posted: August 28, 2019
• Sponsor: Virtua Health, Inc.
• Information provided by (Responsible Party): Virtua Health, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lumbar Spine Degeneration	Biological: 5cc Vivigen and local autograft; Biological: Small kit rhBMP-2 with local autograft	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: 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.
• Primary Purpose: Basic Science
• Official Title: rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study
• Actual Study Start Date: July 3, 2017
• Actual Primary Completion Date: July 27, 2018
• Actual Study Completion Date: July 27, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Mean Oswestry Disability Index (ODI) Score [ Time Frame: Up to 1 year post surgery ]
   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)

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, New Jersey

Virtua Memorial Hospital

Mount Holly, New Jersey, United States, 08060

Sponsors and Collaborators

Virtua Health, Inc.

  Study Documents (Full-Text)

Documents provided by Virtua Health, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] March 8, 2018

More Information

• Responsible Party: Virtua Health, Inc.
• ClinicalTrials.gov Identifier: NCT03527966
• Other Study ID Numbers: IRB G17008
• First Posted: May 17, 2018
• Results First Posted: August 7, 2019
• Last Update Posted: August 28, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Plan to disseminate study findings via conference representation and journal publication using de-identified analyzed data

• 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