Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT03042533
Status:
TERMINATED
Last Update Posted:
2024-05-03
First Post:
2017-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Union Rate of Transverse Tibia Fracture
Sponsor:
Organization:
Raw JSON
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'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dynamic Locking With Backslapping', 'description': 'Nail will be seated using backslapping with dynamic locking\n\nDynamic Locking with Backslapping: Method of Nail fitting', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Healing of Tibia Fracture by Radiographic Exam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Compression', 'description': 'Nail will be seated using conventional compression technique\n\nConventional Compression: Method of Nail fitting'}, {'id': 'OG001', 'title': 'Standard Backslapping', 'description': 'Nail will be seated using standard backslapping technique\n\nStandard Backslapping: Method of Nail fitting'}, {'id': 'OG002', 'title': 'Dynamic Locking With Backslapping', 'description': 'Nail will be seated using backslapping with dynamic locking\n\nDynamic Locking with Backslapping: Method of Nail fitting'}], 'timeFrame': 'One Year', 'description': 'Healing of Tibia Fracture by radiographic exam', 'reportingStatus': 'POSTED', 'populationDescription': 'MD left institution project closed data not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Compression', 'description': 'Nail will be seated using conventional compression technique\n\nConventional Compression: Method of Nail fitting'}, {'id': 'FG001', 'title': 'Standard Backslapping', 'description': 'Nail will be seated using standard backslapping technique\n\nStandard Backslapping: Method of Nail fitting'}, {'id': 'FG002', 'title': 'Dynamic Locking With Backslapping', 'description': 'Nail will be seated using backslapping with dynamic locking\n\nDynamic Locking with Backslapping: Method of Nail fitting'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'MD left program', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Compression', 'description': 'Nail will be seated using conventional compression technique\n\nConventional Compression: Method of Nail fitting'}, {'id': 'BG001', 'title': 'Standard Backslapping', 'description': 'Nail will be seated using standard backslapping technique\n\nStandard Backslapping: Method of Nail fitting'}, {'id': 'BG002', 'title': 'Dynamic Locking With Backslapping', 'description': 'Nail will be seated using backslapping with dynamic locking\n\nDynamic Locking with Backslapping: Method of Nail fitting'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '63', 'upperLimit': '63'}, {'value': '37', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '52'}, {'value': '37', 'groupId': 'BG002', 'lowerLimit': '37', 'upperLimit': '37'}, {'value': '42', 'groupId': 'BG003', 'lowerLimit': '27', 'upperLimit': '63'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-05', 'size': 538507, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-02T12:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant Blinding'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2017-01-27', 'resultsFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-02', 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing of Tibia Fracture by Radiographic Exam', 'timeFrame': 'One Year', 'description': 'Healing of Tibia Fracture by radiographic exam'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Closed Transverse Fracture of Shaft of Tibia']}, 'descriptionModule': {'briefSummary': 'The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Closed Tibia Shaft Fracture Treated with an IMN\n\nExclusion Criteria:\n\n* Unable to consent due to language\n* Unlikely to follow-up for one year'}, 'identificationModule': {'nctId': 'NCT03042533', 'briefTitle': 'Union Rate of Transverse Tibia Fracture', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Union Rates of Transverse Tibia Fractures Managed With Internal Fracture Compression Through an Intramedullary Rod Compared to Standard Backslapping or Backslapping With Dynamic Locking', 'orgStudyIdInfo': {'id': 'STUDY00001680'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Compression', 'description': 'Nail will be seated using conventional compression technique', 'interventionNames': ['Device: Conventional Compression']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Backslapping', 'description': 'Nail will be seated using standard backslapping technique', 'interventionNames': ['Device: Standard Backslapping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dynamic Locking with Backslapping', 'description': 'Nail will be seated using backslapping with dynamic locking', 'interventionNames': ['Device: Dynamic Locking with Backslapping']}], 'interventions': [{'name': 'Conventional Compression', 'type': 'DEVICE', 'description': 'Method of Nail fitting', 'armGroupLabels': ['Conventional Compression']}, {'name': 'Standard Backslapping', 'type': 'DEVICE', 'description': 'Method of Nail fitting', 'armGroupLabels': ['Standard Backslapping']}, {'name': 'Dynamic Locking with Backslapping', 'type': 'DEVICE', 'description': 'Method of Nail fitting', 'armGroupLabels': ['Dynamic Locking with Backslapping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Claude Sagi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently there is no plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Orthopedics', 'investigatorFullName': 'Claude Sagi', 'investigatorAffiliation': 'University of Washington'}}}}