rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures

Virtua Health

Status and phase: Terminated; Phase 4

Conditions: Lumbar Spine Degeneration

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03527966

IRB G17008

Details and patient eligibility

About

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.

Full 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

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 2 patient groups

Intervention group - 5cc Vivigen and local autograft

Active Comparator group

Treatment:

Biological: 5cc Vivigen and local autograft

Control group - small kit rhBMP-2 with local autograft

Active Comparator group

Treatment:

Biological: Small kit rhBMP-2 with local autograft