Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-01-10 @ 6:35 PM
Study NCT ID:
NCT00677950
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2008-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OP-1 Putty for Posterolateral Fusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013123', 'term': 'Spinal Fusion'}], 'ancestors': [{'id': 'D001174', 'term': 'Arthrodesis'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 336}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-09', 'studyFirstSubmitDate': '2008-05-13', 'studyFirstSubmitQcDate': '2008-05-13', 'lastUpdatePostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall success rate at 24 months in the OP-1 Putty and the autograft groups, radiographic demonstration of spinal fusion, ODI improvement of at least 20%, no revisions, removals or supplemental fixations', 'timeFrame': '3, 6, 12, 24 months'}], 'secondaryOutcomes': [{'measure': 'The number of anticipated and unanticipated complications/AEs that occurred within the study population, Visual Analog Scale Results for Pain Assessment, Donor Site Pain, Medication Use', 'timeFrame': '3, 6, 12, 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Degenerative Disc Disease'], 'conditions': ['Degenerative Lumbar Spondylolisthesis']}, 'descriptionModule': {'briefSummary': 'The trial was designed to demonstrate the comparability of the overall success rate in the OP-1 Putty treatment group to the autograft treatment group.', 'detailedDescription': 'A controlled, open- label, blinded radiographic assessment, randomized, prospective, multicenter, multinational pivotal study in which patients with single level (L3-S1) degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent decompression and spinal fusion and received OP-1 Putty or autograft. This study was a one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group and the control autograft group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.\n2. The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.\n3. The subject requires one level lumbar fusion (L-3 to S-1).\n4. The subject has a preoperative Oswestry Disability Index of 30-100.\n\nExclusion Criteria:\n\n1. The subject has active spinal and/or systemic infection.\n2. The subject is morbidly obese.\n3. The subject has a known sensitivity to any component of the OP-1 Putty.\n4. The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.\n5. The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.'}, 'identificationModule': {'nctId': 'NCT00677950', 'briefTitle': 'OP-1 Putty for Posterolateral Fusions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olympus Biotech Corporation'}, 'officialTitle': 'OP-1 Putty for Posterolateral Fusions', 'orgStudyIdInfo': {'id': 'S01-01US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'OP-1 Putty', 'interventionNames': ['Procedure: Spinal fusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Autograft', 'interventionNames': ['Procedure: Spinal fusion']}], 'interventions': [{'name': 'Spinal fusion', 'type': 'PROCEDURE', 'otherNames': ['Lumbar Spinal Fusion'], 'description': 'Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Stanford', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olympus Biotech Corporation', 'class': 'INDUSTRY'}}}}