Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-01-01 @ 10:14 AM
Study NCT ID:
NCT02074969
Status:
COMPLETED
Last Update Posted:
2014-03-03
First Post:
2014-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-28', 'studyFirstSubmitDate': '2014-02-27', 'studyFirstSubmitQcDate': '2014-02-28', 'lastUpdatePostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mobility assessment', 'timeFrame': 'time between hospitalization and one year after intervention', 'description': 'Mobility assessment includes scoring of pre-operative level of mobility and mobility after intervention'}], 'primaryOutcomes': [{'measure': 're-operation rate', 'timeFrame': 'time between intervention and one year after'}], 'secondaryOutcomes': [{'measure': 'Screw-Cut Out', 'timeFrame': 'time between intervention and one year after', 'description': 'evaluation of sliding movements of the hip screw in the sense of a cut-out'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['re-operation rate', 'pertrochanteric fractures', 'GammaNail', 'PFNA', 'Tip-Apex-Distance', 'Parkers-Ratio'], 'conditions': ['Fractures']}, 'referencesModule': {'references': [{'pmid': '20360500', 'type': 'RESULT', 'citation': 'Barton TM, Gleeson R, Topliss C, Greenwood R, Harries WJ, Chesser TJ. A comparison of the long gamma nail with the sliding hip screw for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur: a prospective randomized trial. J Bone Joint Surg Am. 2010 Apr;92(4):792-8. doi: 10.2106/JBJS.I.00508.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the differences between two different types of devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).', 'detailedDescription': 'This trial is a prospective randomized controlled study including the treatment of AO/OTA 31-A2 fractures in 200 patients with 2 different surgical devices. 100 patients are treated with a Gamma Nail 3 (GN3) (Stryker) the other 100 patients with a Proximal Femoral Nail Antirotation (PFNA) (Synthes).\n\nAll surgeries are performed by trauma surgeons at a Level 1 University Hospital. One hundred patients are randomized to the gamma nail and 100 are randomized to the proximal femoral nail for treatment fixation. A 1:1 randomization is performed using sealed envelopes (200 in total), which are opened by the surgeon immediately before the operation.\n\nPatients missing an informed consent form, incomplete chart, or showing a pathologic fracture are getting excluded from final comparisons.\n\nPatients anthropometric data as well as pre-injury mobility assessments, and ASA will be documented. Furthermore the time from admission to going to surgery, surgery length, length of stay and mobility assessment at dischargement are recorded.\n\nAfter surgery the stay in the hospital is documented precisely and patients are scheduled for next appointments 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.\n\nPostoperative X-rays are measured precisely to determine the Tip-Apex Distance (TAD), the Parkers-Ratio, the Singh-Score and the Neck-Shaft-Angle of the injured and contralateral side. Rates of complications as cut-out and reoperation-rates are evaluated. All intra-operative complications are noted and included in the chart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AO/OTA 31-A2 fractures\n* age between 18 - 100 years\n* Signed written informed consent and agreement to attend the planned FUs\n* Able to understand and read country national language at an elementary level\n\nExclusion Criteria:\n\n* missing informed consent form\n* pathological fracture\n* incomplete patient record\n* death within one month of intervention (surgery)\n* prior surgery to the hip\n* polytrauma\n* any additional fracture\n* any implant at the same hip\n* infection'}, 'identificationModule': {'nctId': 'NCT02074969', 'briefTitle': 'Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures - Epidemiological Data and Rates of Complications', 'orgStudyIdInfo': {'id': '2007406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gamma Nail 3', 'description': 'Gamma Nail 3 Stryker.', 'interventionNames': ['Device: Gamma Nail 3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PFNA', 'description': 'PFNA Antirotation Synthes', 'interventionNames': ['Device: PFNA']}], 'interventions': [{'name': 'Gamma Nail 3', 'type': 'DEVICE', 'otherNames': ['Gamma Nail 3 Stryker'], 'description': 'Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.', 'armGroupLabels': ['Gamma Nail 3']}, {'name': 'PFNA', 'type': 'DEVICE', 'otherNames': ['PFNA Antirotation Synthes'], 'description': 'Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA.', 'armGroupLabels': ['PFNA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Austria', 'country': 'Austria', 'facility': 'Department of Trauma, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Harald K. Widhalm, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Trauma, Medical University of Vienna, Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Harry Widhalm', 'investigatorAffiliation': 'Medical University of Vienna'}}}}