Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT00726193
Status:
TERMINATED
Last Update Posted:
2019-01-24
First Post:
2008-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Slow enrollment, lack of follow up', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-22', 'studyFirstSubmitDate': '2008-07-29', 'studyFirstSubmitQcDate': '2008-07-30', 'lastUpdatePostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure for this trial will be the percentage of successful tibia unions achieved', 'timeFrame': '8 Months'}], 'secondaryOutcomes': [{'measure': 'Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change from Baseline), SF-36 Health Survey (Change from Baseline)', 'timeFrame': '8 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tibia Fracture Non Union Bone']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.', 'detailedDescription': 'This clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'private practice patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of a tibia nonunion.\n2. Male or female between ages of 18 and 75 years old, inclusive\n\nExclusion Criteria:\n\n1. Subject has open wounds or underlying osteomyelitis.\n2. Subject has associated multiple traumas, and/or fractures that are not anatomically reduced or lose reduction at later time points.\n3. If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating.\n4. Subject has an implanted unipolar pacemaker.\n5. Subject has active cancer.\n6. Subject has severe peripheral vascular disease (ABI \\<0.4)'}, 'identificationModule': {'nctId': 'NCT00726193', 'briefTitle': 'Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective Randomized Multi - Center Clinical Outcomes Collection Study To Analyze The Effect Of Ebi Osteogen™ Direct Current Stimulator On The Surgical Reconstruction Of Tibia Nonunions', 'orgStudyIdInfo': {'id': 'CS-012'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 - standard films', 'description': 'Tibia reconstruction surgery with OsteoGen™ with standard radiographs', 'interventionNames': ['Device: OsteoGen']}, {'label': '2 - Standard films plus CT', 'description': 'Tibia reconstruction surgery with OsteoGen™ with standard radiographs and additional CT scan at 10 and 18 weeks.', 'interventionNames': ['Device: OsteoGen']}], 'interventions': [{'name': 'OsteoGen', 'type': 'DEVICE', 'description': 'OsteoGen Implatable stimulator', 'armGroupLabels': ['1 - standard films', '2 - Standard films plus CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43231', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Orthopedic Foot and Ankle Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Joel Batts', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biomet Spine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}