Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-29 @ 10:25 AM
Study NCT ID:
NCT01238068
Status:
UNKNOWN
Last Update Posted:
2010-11-10
First Post:
2010-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Results of Treatment by Gamma Nail Versus Dynamic Hip Screw for Unstable Intertrochanteric Hip Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-09', 'studyFirstSubmitDate': '2010-10-26', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hip function score', 'timeFrame': '1 year', 'description': 'at the last clinical visit (1 year) the patient will perform hip score testing and record.'}], 'secondaryOutcomes': [{'measure': 'x-ray, surgical outcome', 'timeFrame': '1 year', 'description': 'in the last clincial visit x ray finding will be record and the overall surgical outcome (infection, bleeding etc.) will be record'}]}, 'conditionsModule': {'conditions': ['Intertrochanteric Fractures of the Hip']}, 'referencesModule': {'references': [{'pmid': '35080771', 'type': 'DERIVED', 'citation': 'Lewis SR, Macey R, Gill JR, Parker MJ, Griffin XL. Cephalomedullary nails versus extramedullary implants for extracapsular hip fractures in older adults. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD000093. doi: 10.1002/14651858.CD000093.pub6.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagozied with acute intertrochantric unstable fracture\n* a minimum minimental score of 6\n* ability to walk 500 meters indepedently\n\nExclusion Criteria:\n\n* pathological fracture\n* multiple fractures\n* neurological conditions'}, 'identificationModule': {'nctId': 'NCT01238068', 'briefTitle': 'Comparison of the Results of Treatment by Gamma Nail Versus Dynamic Hip Screw for Unstable Intertrochanteric Hip Fractures', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'orgStudyIdInfo': {'id': 'TAMSC-10-OS-10-357-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gamma nail, fracture stabilization, better walking', 'interventionNames': ['Device: gamma nail stryker']}], 'interventions': [{'name': 'gamma nail stryker', 'type': 'DEVICE', 'description': 'for acute unstable pertrochantric fractures the subjects will be treated randomaly with either Gamma nail device Vs Dynamic hip screw', 'armGroupLabels': ['Gamma nail, fracture stabilization, better walking']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': 'ortal sgal, MD', 'role': 'CONTACT', 'email': 'ortal_San@yahoo.com'}], 'facility': 'Tel Aviv Medical center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'ortal segal, MD', 'role': 'CONTACT', 'email': 'ortal_San@yahoo.com', 'phone': '972-52-60172'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'ortal segal', 'oldOrganization': 'TASMC'}}}}