Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-05 @ 9:36 AM
Study NCT ID:
NCT02247661
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2014-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'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'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2014-09-20', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trendelenburg Test', 'timeFrame': '1 year', 'description': '30 seconds standing on the operated leg'}], 'secondaryOutcomes': [{'measure': 'Abductor strenght', 'timeFrame': '1 year', 'description': 'Dynamometry'}, {'measure': 'Trochanteric tenderness', 'timeFrame': '1 year', 'description': 'Algometry'}, {'measure': 'Trochanteric tenderness', 'timeFrame': '1 year', 'description': 'Palptation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Femoral neck fracture,surgical approach, limp, abductor strenght, trochanteric pain'], 'conditions': ['Femoral Neck Fracture', 'Trochanteric Pain']}, 'referencesModule': {'references': [{'pmid': '20860452', 'type': 'BACKGROUND', 'citation': 'Skoldenberg O, Ekman A, Salemyr M, Boden H. Reduced dislocation rate after hip arthroplasty for femoral neck fractures when changing from posterolateral to anterolateral approach. Acta Orthop. 2010 Oct;81(5):583-7. doi: 10.3109/17453674.2010.519170.'}, {'pmid': '8648312', 'type': 'BACKGROUND', 'citation': 'Pai VS. Significance of the Trendelenburg test in total hip arthroplasty. Influence of lateral approaches. J Arthroplasty. 1996 Feb;11(2):174-9. doi: 10.1016/s0883-5403(05)80013-0.'}, {'pmid': '19359133', 'type': 'BACKGROUND', 'citation': 'Kiyama T, Naito M, Shinoda T, Maeyama A. Hip abductor strengths after total hip arthroplasty via the lateral and posterolateral approaches. J Arthroplasty. 2010 Jan;25(1):76-80. doi: 10.1016/j.arth.2008.11.001. Epub 2009 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'A prospective cohort study to compare the direct lateral and poster-lateral approach concerning abductor function. Patients admitted with a femoral neck fracture operated with a hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for inclusion. Patients with altered mental status SPMSQ \\>7, pathological fractures, non-walkers were excluded.\n\nThose who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1 year postoperatively by clinical examination. Sample size were estimated to 30 patient in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry, trochanteric tenderness measured with algometry and palptation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Sundsvall hospital with a displaced femoral neck fracture operated with either a total or hemiarthroplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Displaced femoral neck fracture\n* Walker\n* Hemarthroplasty\n* Preiffer test \\>7/10\n\nExclusion Criteria:\n\n* Pathological fracture\n* Non-walker\n* Pfeiffer test \\<7/10 indicating mental alteration.'}, 'identificationModule': {'nctId': 'NCT02247661', 'acronym': 'HASAP', 'briefTitle': 'Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Sundsvall Hospital'}, 'officialTitle': 'Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture: A Comparison Between the Lateral and Posterolateral Approaches', 'orgStudyIdInfo': {'id': 'SM_II'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Direct lateral approach', 'description': 'Total or hemiarthroplasty operated with direct-lateral approach.'}, {'label': 'Postero-lateral approach', 'description': 'Total or hemiarthroplasty operated with postero-lateral approach.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '851 86', 'city': 'Sundsvall', 'state': 'Västernorrland County', 'country': 'Sweden', 'facility': 'Orthopaedic department, Sundsvall hospital', 'geoPoint': {'lat': 62.39129, 'lon': 17.3063}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sundsvall Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head FoU', 'investigatorFullName': 'Lennart Bråbäck', 'investigatorAffiliation': 'Sundsvall Hospital'}}}}