Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-26 @ 8:06 PM
Study NCT ID:
NCT03527966
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2018-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhoopes@virtua.org', 'phone': '856-761-3904', 'title': 'Jillian Hoopes', 'organization': 'Virtua Health Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Zero participants in the control group were at risk for all-cause mortality, serious adverse events, and other (not including serious) adverse events as the study was terminated early before any patients enrolled in that study arm. Adverse events collected per clinicaltrials.gov definitions. Protocol considered opioid related adverse events (ORAEs) an area of special interest but none were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group - 5cc Vivigen and Local Autograft', 'description': '5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group - Small Kit rhBMP-2 With Local Autograft', 'description': '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', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Oswestry Disability Index (ODI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group - 5cc Vivigen and Local Autograft', 'description': '5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft'}, {'id': 'OG001', 'title': 'Control Group - Small Kit rhBMP-2 With Local Autograft', 'description': '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'}], 'classes': [{'title': 'ODI at Two weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '87'}]}]}, {'title': 'ODI at Six weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '58'}]}]}, {'title': 'ODI at Three months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '70'}]}]}, {'title': 'ODI at Six months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '36'}]}]}, {'title': 'ODI at 1 year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 year post surgery', 'description': '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)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients did not attend every follow up visit and then were ultimately lost to follow up. Study was also terminated early when the PI left his practice so on patients were never randomized in the control group.'}, {'type': 'SECONDARY', 'title': 'Mean Postoperative Leg/Back Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group - 5cc Vivigen and Local Autograft', 'description': '5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft'}, {'id': 'OG001', 'title': 'Control Group - Small Kit rhBMP-2 With Local Autograft', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average of 3 days in hospital', 'description': 'Pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early before any patients were randomized to the control group.'}, {'type': 'SECONDARY', 'title': 'Mean Inpatient Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group - 5cc Vivigen and Local Autograft', 'description': '5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft'}, {'id': 'OG001', 'title': 'Control Group - Small Kit rhBMP-2 With Local Autograft', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average of 3 days in hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early before any patients were randomized to the control group.'}, {'type': 'SECONDARY', 'title': 'Fusion Rates, Evaluated Via CT Scan I Year Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group - 5cc Vivigen and Local Autograft', 'description': '5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft'}, {'id': 'OG001', 'title': 'Control Group - Small Kit rhBMP-2 With Local Autograft', 'description': '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'}], 'timeFrame': '1 year post surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'No patient returned for their 1 year post op scan'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group - 5cc Vivigen and Local Autograft', 'description': '5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft'}, {'id': 'FG001', 'title': 'Control Group - Small Kit rhBMP-2 With Local Autograft', 'description': '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group - 5cc Vivigen and Local Autograft', 'description': '5cc Vivigen and local autograft: The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft'}, {'id': 'BG001', 'title': 'Control Group - Small Kit rhBMP-2 With Local Autograft', 'description': '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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '65'}, {'value': '52.6', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Study was terminated early when PI left the practice. Three patients were randomized to the intervention group. Zero were randomized to the control group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-08', 'size': 373658, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-26T15:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The surgical team, including the surgeons, will be blinded to the treatment options until decompression/instrumentation have been completed. The patients and all staff, including hospital nursing staff, case management, and physical therapists, will be blinded as to which bone graft treatment the patient received.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'PI left the institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2018-05-04', 'resultsFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2018-05-04', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-12', 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Oswestry Disability Index (ODI) Score', 'timeFrame': 'Up to 1 year post surgery', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Mean Postoperative Leg/Back Pain Score', 'timeFrame': 'Average of 3 days in hospital', 'description': 'Pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible'}, {'measure': 'Mean Inpatient Length of Stay', 'timeFrame': 'Average of 3 days in hospital'}, {'measure': 'Fusion Rates, Evaluated Via CT Scan I Year Postoperatively', 'timeFrame': '1 year post surgery'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spine Degeneration']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n1. 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\n2. Comparable inpatient length of stay (LOS)\n3. 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\n4. Comparable fusion rates, evaluated via CT scan I year postoperatively'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 or older;\n2. 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;\n3. Willing to provide informed consent, participate in study, and comply with study protocol.\n\nExclusion Criteria:\n\n1. Pregnant or contemplating pregnancy prior to surgery;\n2. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);\n3. Surgery involving more than 2 vertebral levels;\n4. 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).\n5. Lactating women\n6. Patients who have a known or suspected allergy to Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin\n7. Immune compromised patients"}, 'identificationModule': {'nctId': 'NCT03527966', 'briefTitle': 'rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Virtua Health, Inc.'}, 'officialTitle': 'rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'IRB G17008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group - 5cc Vivigen and local autograft', 'interventionNames': ['Biological: 5cc Vivigen and local autograft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group - small kit rhBMP-2 with local autograft', 'interventionNames': ['Biological: Small kit rhBMP-2 with local autograft']}], 'interventions': [{'name': '5cc Vivigen and local autograft', 'type': 'BIOLOGICAL', 'description': 'The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft', 'armGroupLabels': ['Intervention group - 5cc Vivigen and local autograft']}, {'name': 'Small kit rhBMP-2 with local autograft', 'type': 'BIOLOGICAL', 'description': 'The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft', 'armGroupLabels': ['Control group - small kit rhBMP-2 with local autograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08060', 'city': 'Mount Holly', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Virtua Memorial Hospital', 'geoPoint': {'lat': 39.99289, 'lon': -74.78766}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Plan to disseminate study findings via conference representation and journal publication using de-identified analyzed data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virtua Health, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}