Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT02657902
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2016-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Fractures With Gamma 3 Nail?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'lastUpdateSubmitDate': '2016-01-15', 'studyFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2016-01-15', 'lastUpdatePostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cutout rate', 'timeFrame': '3 months after intervention', 'description': 'Differences in the Cutout rate of the femoral head screw with/without U-Blade antirational screw'}], 'secondaryOutcomes': [{'measure': 'Mobility', 'timeFrame': '3 months after intervention', 'description': 'Mobility of the patients 3 months after intervention measured with the Parker mobility score'}]}, 'conditionsModule': {'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)\n\nExclusion Criteria:\n\n* Patients with pathological fractures\n* Patients treated with a long gamma nail were excluded'}, 'identificationModule': {'nctId': 'NCT02657902', 'briefTitle': 'Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Fractures With Gamma 3 Nail?', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Classified Fractures With Gamma 3 Nail?', 'orgStudyIdInfo': {'id': '1960/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gamma 3 Nail', 'description': 'Fractures that were treated with a Gamma 3 nail', 'interventionNames': ['Procedure: Fractures were treated with a Gamma 3 intramedullary nail']}, {'label': 'Gamma 3 Nail + U-Blade', 'description': 'Fractures that were treated with a Gamma 3 nail and additional with antirotation U-blade lag screws.', 'interventionNames': ['Procedure: Fractures were treated with a Gamma 3 intramedullary nail + U-Blade']}], 'interventions': [{'name': 'Fractures were treated with a Gamma 3 intramedullary nail', 'type': 'PROCEDURE', 'armGroupLabels': ['Gamma 3 Nail']}, {'name': 'Fractures were treated with a Gamma 3 intramedullary nail + U-Blade', 'type': 'PROCEDURE', 'armGroupLabels': ['Gamma 3 Nail + U-Blade']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Julian Joestl', 'investigatorAffiliation': 'Medical University of Vienna'}}}}