Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-16 @ 2:45 PM
Study NCT ID:
NCT02285127
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2014-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2014-11-04', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reoperation', 'timeFrame': 'within 1 year'}, {'measure': 'Mortality', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'SF (short form)-36', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pertrochanteric Hip Fracture']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Is there a functional outcome difference when treating pertrochanteric fractures with a short or long cephalomedullary nail?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* AO/OTA fracture classification 31(A-B) (1-3).\n* Age greater than 18 years old.\n\nExclusion Criteria\n\n-Less than 18 years old.'}, 'identificationModule': {'nctId': 'NCT02285127', 'briefTitle': 'Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study', 'orgStudyIdInfo': {'id': '14-002490'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short nail implant', 'description': 'used to treat pertrochanteric fractures', 'interventionNames': ['Procedure: Short versus long cephalomedullary Intramedullary nail']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long nail implant', 'description': 'used to treat pertrochanteric fractures', 'interventionNames': ['Procedure: Short versus long cephalomedullary Intramedullary nail']}], 'interventions': [{'name': 'Short versus long cephalomedullary Intramedullary nail', 'type': 'PROCEDURE', 'description': 'Biomet Affixus Short and Long hip fracture nail. Stryker Gamma Short and Long hip fracture nail.', 'armGroupLabels': ['Long nail implant', 'Short nail implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Stephen Sems, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Orthopedics', 'investigatorFullName': 'Stephen A. Sems', 'investigatorAffiliation': 'Mayo Clinic'}}}}