rhBMP-2 Versus Vivigen 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

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