rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

Phase 4TerminatedNCT03527966

Virtua Health, Inc.3 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Lumbar Spine Degeneration

Interventions

5cc Vivigen and local autograftBIOLOGICAL

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

Small kit rhBMP-2 with local autograftBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Virtua Memorial Hospital

Mount Holly, New Jersey, United States

Outcomes

Primary Outcomes

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)

Time frame: Up to 1 year post surgery

Secondary Outcomes

Mean Postoperative Leg/Back Pain Score

Pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible

Time frame: Average of 3 days in hospital

Mean Inpatient Length of Stay

Time frame: Average of 3 days in hospital

Fusion Rates, Evaluated Via CT Scan I Year Postoperatively

Time frame: 1 year post surgery

Data from ClinicalTrials.gov

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