Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-22 @ 4:54 PM
Study NCT ID:
NCT03117868
Status:
COMPLETED
Last Update Posted:
2020-07-20
First Post:
2017-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2017-04-13', 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality at 6 months of EFSF patients', 'timeFrame': '6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Femur Fracture', 'Morality']}, 'descriptionModule': {'briefSummary': 'Fractures of the upper femur (EFSF) represent a major public health problem in the elderly. Approximately 1.6 million patients are victims each year of an EFSF and this number is increasing as a result of the aging of the population.\n\nIn a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of the fracture. In surviving patients, the impact on loss of autonomy and degradation of quality of life is considerable.\n\nThe reduction of the incidence of post-operative complications includes the identification of risk factors.\n\nNo prospective study in Amiens has investigated the mortality and the study of the variables involved in the prognosis and long-term mortality of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients operated with an EFSF and meeting the inclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients operated from a fracture of traumatic origin of the ESF to the emergency block at the CHU of Amiens\n* Patients transferred to the CHU after being cared for in another structure will be included.\n* If a patient successively presents a fracture of each upper extremity of the femur outside of a surgical resumption, two inclusions will be realized\n\nExclusion Criteria:\n\n* Do not include non-traumatic fractures of the upper end of the femur (pathological fractures: cancer, for example)\n* Fractures of the upper end of the femur associated with polytrauma will not be included.'}, 'identificationModule': {'nctId': 'NCT03117868', 'acronym': 'FESF-Amiens', 'briefTitle': 'Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens', 'orgStudyIdInfo': {'id': 'RNI2016-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Study of mortality at 6 months', 'type': 'OTHER', 'description': 'The objective is to provide strong arguments for establishing a dynamic of collective care for patients suffering from an EFSF'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'state': 'Picardie', 'country': 'France', 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}