Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-21 @ 10:56 PM
Study NCT ID:
NCT01484405
Status:
TERMINATED
Last Update Posted:
2014-11-11
First Post:
2011-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Low enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-10', 'studyFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dislocation rates', 'timeFrame': '12 months', 'description': 'Radiographic variables: AP and lateral views of hip and pelvis'}], 'secondaryOutcomes': [{'measure': 'other complications', 'timeFrame': '12 months', 'description': 'Hospital readmission, reoperation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['surgical approach for total hip arthroplasty'], 'conditions': ['Femur Fracture']}, 'descriptionModule': {'briefSummary': 'There are two surgical approaches (incision types) used by surgeons who do total hip replacements. The purpose of this study is to determine which type of surgical approach (incision type) produces the best results for patients who have a total hip replacement.\n\nNull Hypothesis : There is no difference in complication rate, functional outcome, surgical time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or ORIF for femoral neck fractures.', 'detailedDescription': 'Patients undergoing Total hip Arthroplasty following displaced femoral neck fracture, will be consented and randomized to one of two surgical approaches ( anterior or posterior).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Displaced femoral neck fracture\n* Age 65 years or older\n* Acute, femoral neck fracture\n\nExclusion Criteria:\n\nCognitive impairment\n\n* Active Infection\n* Limited functional capacity (nursing home resident, non-ambulatory, severe cardiorespiratory disease)\n* Limited life expectancy\n* Pathologic fracture (tumor)\n* Acetabular fractures'}, 'identificationModule': {'nctId': 'NCT01484405', 'acronym': 'THA', 'briefTitle': 'Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture', 'organization': {'class': 'NETWORK', 'fullName': 'Florida Orthopaedic Institute'}, 'officialTitle': 'Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture', 'orgStudyIdInfo': {'id': 'THA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'anterolateral approach', 'description': 'surgical intervention THA anterolateral approach', 'interventionNames': ['Procedure: anterolateral approach']}, {'type': 'OTHER', 'label': 'posterior approach', 'description': 'surgical intervention THA posterior approach', 'interventionNames': ['Procedure: posterior approach']}], 'interventions': [{'name': 'posterior approach', 'type': 'PROCEDURE', 'otherNames': ['Total hip Athroplasty following fracture'], 'description': 'Surgical approach for Total Hip Arthroplasty', 'armGroupLabels': ['posterior approach']}, {'name': 'anterolateral approach', 'type': 'PROCEDURE', 'otherNames': ['Total hip Athroplasty following fracture'], 'description': 'anterolateral surgical approach', 'armGroupLabels': ['anterolateral approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa general Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'St Josephs Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'David Watson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Orthopaedic Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida Orthopaedic Institute', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Orthopaedic Trauma Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}