Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-28 @ 6:50 AM
Study NCT ID:
NCT01098604
Status:
COMPLETED
Last Update Posted:
2014-03-20
First Post:
2010-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-10-23', 'releaseDate': '2018-03-19'}], 'estimatedResultsFirstSubmitDate': '2018-03-19'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-19', 'studyFirstSubmitDate': '2010-04-01', 'studyFirstSubmitQcDate': '2010-04-02', 'lastUpdatePostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of dislocation in each head size', 'timeFrame': '6 weeks', 'description': 'to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.'}, {'measure': 'rate of dislocation in each head size', 'timeFrame': '3 months', 'description': 'to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.'}, {'measure': 'rate of dislocation in each head size', 'timeFrame': '6 months', 'description': 'to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.'}, {'measure': 'rate of dislocation in each head size', 'timeFrame': '9 months', 'description': 'to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.'}, {'measure': 'rate of dislocation in each head size', 'timeFrame': '12 months', 'description': 'to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.'}, {'measure': 'rate of dislocation in each head size', 'timeFrame': '24 months', 'description': 'to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.'}], 'secondaryOutcomes': [{'measure': 'clinical results using Harris Hip Score', 'timeFrame': '6 weeks', 'description': 'to compare the clinical results such as pain, function, range of motion between both groups.'}, {'measure': 'clinical results using Harris Hip Score', 'timeFrame': '3 months', 'description': 'to compare the clinical results such as pain, function, range of motion between both groups.'}, {'measure': 'clinical results using Harris Hip Score', 'timeFrame': '6 months', 'description': 'to compare the clinical results such as pain, function, range of motion between both groups.'}, {'measure': 'clinical results using Harris Hip Score', 'timeFrame': '9 months', 'description': 'to compare the clinical results such as pain, function, range of motion between both groups.'}, {'measure': 'clinical results using Harris Hip Score', 'timeFrame': '12 months', 'description': 'to compare the clinical results such as pain, function, range of motion between both groups.'}, {'measure': 'clinical results using Harris Hip Score', 'timeFrame': '24 months', 'description': 'to compare the clinical results such as pain, function, range of motion between both groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Hip']}, 'descriptionModule': {'briefSummary': 'It has been postulated that use of a larger femoral head could reduce the risk of dislocation after total hip arthroplasty, but only limited clinical data have been presented in third generation alumina bearings.\n\nThe purpose of this study is to evaluate the effect of femoral head size for total hip arthroplasty using third generation alumina bearings on the joint stability and clinical results.\n\nThe investigators hypothesized that larger ceramic head group has a similar rate of dislocation and clinical results in smaller ceramic head group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* osteonecrosis of femoral head\n* primary or secondary osteoarthritis of the hips\n* femoral neck fracture\n\nExclusion Criteria:\n\n* previous hemi- or total hip arthroplasty\n* highly dislocated or severe ankylosed hip\n* patients who are considered potentially unreliable or who may not reliably attend study visits'}, 'identificationModule': {'nctId': 'NCT01098604', 'acronym': 'THA', 'briefTitle': 'The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SNU 08-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '32mm ceramic head group', 'description': 'patients performed with THA using 32mm ceramic head', 'interventionNames': ['Device: 32mm ceramic head group']}, {'type': 'ACTIVE_COMPARATOR', 'label': '28mm ceramic head group', 'description': 'patients performed with THA using 28mm ceramic head', 'interventionNames': ['Device: 28mm ceramic head group']}], 'interventions': [{'name': '32mm ceramic head group', 'type': 'DEVICE', 'description': 'we performed THA using 32mm ceramic head in this group.', 'armGroupLabels': ['32mm ceramic head group']}, {'name': '28mm ceramic head group', 'type': 'DEVICE', 'description': 'we performed THA using 28mm ceramic head in this group.', 'armGroupLabels': ['28mm ceramic head group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul national University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Kyung-Hoi Koo, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kyung-Hoi, Koo/professor', 'oldOrganization': 'Seoul National University Bundang Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-03-19', 'type': 'RELEASE'}, {'date': '2018-10-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Seoul National University Bundang Hospital (Kyung-Hoi, Koo/professor)'}}}}