Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-25 @ 4:07 AM
Study NCT ID:
NCT02246335
Status:
UNKNOWN
Last Update Posted:
2016-08-30
First Post:
2014-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-29', 'studyFirstSubmitDate': '2014-09-18', 'studyFirstSubmitQcDate': '2014-09-19', 'lastUpdatePostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Harris hip score', 'timeFrame': '2 years', 'description': 'The hip specific outcome score Harris hip score at 2 years will be the main outcome variable'}], 'secondaryOutcomes': [{'measure': 'EQ-5D', 'timeFrame': '2 years', 'description': 'Health-related quality of life at 2 years'}, {'measure': 'EQ-5D', 'timeFrame': '4 years', 'description': 'Health-related quality of life at 4 years'}, {'measure': 'EQ-5D', 'timeFrame': '6 years', 'description': 'Health-related quality of life at 6 years'}, {'measure': 'EQ-5D', 'timeFrame': '10 years', 'description': 'Health-related quality of life at 10 years'}, {'measure': 'Adverse events', 'timeFrame': '2 years', 'description': 'All hip related adverse events at 2 years'}, {'measure': 'Adverse events', 'timeFrame': '4 years', 'description': 'All hip related adverse events at 4 years'}, {'measure': 'Adverse events', 'timeFrame': '6 years', 'description': 'All hip related adverse events at 6 years'}, {'measure': 'Adverse events', 'timeFrame': '10 years', 'description': 'All hip related adverse events at 10 years'}, {'measure': 'Harris hip score', 'timeFrame': '4 years', 'description': 'Harris hip score at 4 years'}, {'measure': 'Harris hip score', 'timeFrame': '6 years', 'description': 'Harris hip score at 6 years'}, {'measure': 'Harris hip score', 'timeFrame': '10 years', 'description': 'Harris hip score at 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Femoral Neck Fractures']}, 'referencesModule': {'references': [{'pmid': '26480938', 'type': 'DERIVED', 'citation': 'Skoldenberg O, Chammout G, Mukka S, Muren O, Nasell H, Hedbeck CJ, Salemyr M. HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial. BMC Musculoskelet Disord. 2015 Oct 19;16:307. doi: 10.1186/s12891-015-0763-3.'}]}, 'descriptionModule': {'briefSummary': 'Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly', 'detailedDescription': 'Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute displaced femoral neck fracture of hip (Garden classification 3-4)\n* Independent walker with or without walking aides\n* Patient willing to participate in the study and give written consent.\n\nExclusion Criteria:\n\n* Fracture older than 36 hours before admission\n* Osteoarthritis in the fractured hip\n* Rheumatoid arthritis in the fractured hip\n* Pathological fractures\n* Contraindication for hip arthroplasty surgery\n* Not suitable for inclusion for other reasons e.g. substance abuse'}, 'identificationModule': {'nctId': 'NCT02246335', 'acronym': 'HOPE', 'briefTitle': 'Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly', 'organization': {'class': 'OTHER', 'fullName': 'Danderyd Hospital'}, 'officialTitle': 'Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'HOPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Hemiarthroplasty', 'interventionNames': ['Device: Cemented hemiarthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group', 'description': 'Total hip arthroplasty', 'interventionNames': ['Device: Cemented total hip arthroplasty']}], 'interventions': [{'name': 'Cemented total hip arthroplasty', 'type': 'DEVICE', 'armGroupLabels': ['Treatment group']}, {'name': 'Cemented hemiarthroplasty', 'type': 'DEVICE', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Orthopaedic department, Danderyd Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danderyd Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Ph D', 'investigatorFullName': 'Olof Skoldenberg', 'investigatorAffiliation': 'Danderyd Hospital'}}}}