rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

Study Overview
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Brief Summary
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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
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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: 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 Comparable inpatient length of stay (LOS) 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 Comparable fusion rates, evaluated via CT scan I year postoperatively

Official Title
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rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study

Conditions
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Lumbar Spine Degeneration

Intervention / Treatment
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* Biological: 5cc Vivigen and local autograft
* Biological: Small kit rhBMP-2 with local autograft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group - 5cc Vivigen and local autograft<br> | Biological: 5cc Vivigen and local autograft<br>* The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft<br>|
| Active Comparator: Control group - small kit rhBMP-2 with local autograft<br> | Biological: Small kit rhBMP-2 with local autograft<br>* The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft<br>|

What is the study measuring?
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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 |