rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

Phase 4

Terminated

Interventions: Biological: 5cc Vivigen and local autograft
Biological: Small kit rhBMP-2 with local autograft

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.

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

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Intervention group - 5cc Vivigen and local autograft	5cc Vivigen and local autograft	-
Control group - small kit rhBMP-2 with local autograft	Small kit rhBMP-2 with local autograft	-

Primary Outcome Measures

Name	Time	Method
Mean Oswestry Disability Index (ODI) Score	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

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