Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
Study NCT ID:
NCT03975868
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2019-06-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092526', 'term': 'Proximal Femoral Fractures'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-04', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical failure defined by varus fracture collapse and lag-screw cut-out with extrusion through the femoral head', 'timeFrame': '3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cut-out', 'Gamma nail', 'Lag-screw', 'Tip-apex distance', 'Trochanteric fracture'], 'conditions': ['Proximal Femoral Fracture']}, 'descriptionModule': {'briefSummary': 'Proximal femoral fracture is associated with severe morbidity and mortality and high socioeconomic costs. The main mechanical complication of internal fixation in trochanteric fracture is lag-screw cut-out through the femoral head. Several factors are involved, but remain controversial. The aim of the present study was to determine risk factors for cut-out in internal fixation of extracapsular proximal femoral fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 75 years old operated on for extracapsular proximal femoral fracture.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 75 years of age\n* Operated on for extracapsular proximal femoral fracture\n* After bodyheight fall\n\nExclusion Criteria:\n\n* Intra-capsular fractures\n* trochantero-diaphyseal fractures\n* subtrochanteric fractures\n* fractures involving pathological bone'}, 'identificationModule': {'nctId': 'NCT03975868', 'briefTitle': 'Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.', 'orgStudyIdInfo': {'id': '30342858'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.', 'type': 'OTHER', 'description': 'Identification of factors for mechanical failure of internal fixation of extracapsular proximal femoral fracture in over 75 year olds'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}