Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-26 @ 11:40 PM
Study NCT ID:
NCT01483404
Status:
WITHDRAWN
Last Update Posted:
2012-11-12
First Post:
2011-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of the Microcirculation of the Caput Femoris After Fracture of the Femoral Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-09', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2011-11-29', 'lastUpdatePostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microcirculation of the caput femoris befor the capsula of the joint is opend', 'description': 'Four Values are measured:\n\noxygen saturation local Hb local blood flow local blood velocity'}], 'secondaryOutcomes': [{'measure': 'Microcirculaiton of the caput femoris after the capusla of the joint has been surgically opened and the hematoma has been removed', 'description': 'Four values are measured:\n\noxygen saturation local Hb local blood flow local blood velocity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['microcirculation', 'caput femoris'], 'conditions': ['Microcirculation of the Caput Femoris']}, 'descriptionModule': {'briefSummary': 'This project investigates wether the intra-capsular hematoma, that often occurs after fracture of the femural neck, decreases the capillary blood flow of the caput femoris.\n\nDuring operation the measuring device of the O2c-machine in placed on the joint capsula first and afterwards, after surgical opening of the capsula, on the femur directly. The integral of the microcirculation of both parts of the femur is measured in both settings. So the capillary blood flow is measured with the hematoma still in situ, eventually putting pressure on the caput femoris and after the capsula has been opened, the pressure relieved and the hematoma removed. Both measurements are compared for each patient.\n\nThe O2c-machine measures non-invasive with light waves and laser-doppler. The sounding rod is packed in a sterile tube to prevent any contamination of the operation site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with fracture of the femural neck, who are treated in the University Hospital Aachen', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medial fracture of the femural neck\n* surgical treatment (hip replacement)\n\nExclusion Criteria:Polytrauma\n\n* pathologic fracture\n* conservative treatment\n* soft tissue damage\n* delay of surgery more than 3 days\n* Immune default\n* polytrauma'}, 'identificationModule': {'nctId': 'NCT01483404', 'acronym': 'MicroFemNeck', 'briefTitle': 'Identification of the Microcirculation of the Caput Femoris After Fracture of the Femoral Neck', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Identification of Microcirculation in Fracture of the Femural Neck: How Does the Intracapsular Hematoma Affect the Capillary Bloodflow in the Caput Femoris?', 'orgStudyIdInfo': {'id': 'CTC-A10-30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with fracture of femural neck', 'description': 'All patient with fracture of the femural neck in the listed period of time', 'interventionNames': ['Procedure: Measurement with O2c']}], 'interventions': [{'name': 'Measurement with O2c', 'type': 'PROCEDURE', 'description': 'Intra-surgery measurement of the microcirculation with the O2c device', 'armGroupLabels': ['Patient with fracture of femural neck']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'RWTH Aachen University Hospital', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Hans-Christoph Pape, Univ-prof.MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chief of medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}