Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
3 participants
INTERVENTIONAL
2017-07-03
2018-07-27
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Intervention group - 5cc Vivigen and local autograft
5cc Vivigen and local autograft
The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
Control group - small kit rhBMP-2 with local autograft
Small kit rhBMP-2 with local autograft
The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
Interventions
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5cc Vivigen and local autograft
The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
Small kit rhBMP-2 with local autograft
The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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Virtua Health, Inc.
OTHER
Responsible Party
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Locations
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Virtua Memorial Hospital
Mount Holly, New Jersey, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB G17008
Identifier Type: -
Identifier Source: org_study_id
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