Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-05 @ 5:44 PM
Study NCT ID:
NCT02196792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-06-21
First Post:
2014-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-19', 'size': 470955, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-01T07:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-05-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2030-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-17', 'studyFirstSubmitDate': '2014-07-14', 'studyFirstSubmitQcDate': '2014-07-20', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean head penetration from baseline to 5 year follow-up', 'timeFrame': 'From baseline to 5 years', 'description': 'Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up'}], 'secondaryOutcomes': [{'measure': 'Mean cup migration form baseline to 5 year follow-up', 'timeFrame': 'From baseline to 5 years', 'description': 'Mean cup migration assessed using RSA from baseline to 5 year follow-up'}, {'measure': 'Mean change in clinical outcome score from baseline to 5 year follow-up', 'timeFrame': 'From baseline to 5 years', 'description': 'Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Joint Diseases', 'Musculoskeletal Diseases', 'radiostereometric analysis', 'Total hip arthroplasty'], 'conditions': ['Osteoarthritis, Hip', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Primary idiopathic arthritis,\n* Eligible for uncemented total hip arthroplasty\n* 40 to70 years of age,\n* Cup size of 54mm and above\n\nExclusion Criteria:\n\n* Anteversion where non-standard stem can be used,\n* Dysplasia (Center-edge angle of Wiberg \\< 20°),\n* Malignant condition\n* Prior radiotherapy\n* Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),\n* Complications during surgery (requiring screws in shell or femoral cerclage)"}, 'identificationModule': {'nctId': 'NCT02196792', 'briefTitle': 'Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial', 'orgStudyIdInfo': {'id': 'project-ID S-20080151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'E-Poly/32 mm', 'description': 'E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.', 'interventionNames': ['Device: E-Poly liner', 'Device: 32 mm femoral head']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'E-Poly/36 mm', 'description': 'E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.', 'interventionNames': ['Device: E-Poly liner', 'Device: 36 mm femoral head']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ArComXL/32 mm', 'description': 'ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.', 'interventionNames': ['Device: ArComXL liner', 'Device: 32 mm femoral head']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ArComXL/36 mm', 'description': 'ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.', 'interventionNames': ['Device: ArComXL liner', 'Device: 36 mm femoral head']}], 'interventions': [{'name': 'E-Poly liner', 'type': 'DEVICE', 'description': 'E-Poly liner with a titanium cup', 'armGroupLabels': ['E-Poly/32 mm', 'E-Poly/36 mm']}, {'name': 'ArComXL liner', 'type': 'DEVICE', 'description': 'ArComXL liner with a titanium cup', 'armGroupLabels': ['ArComXL/32 mm', 'ArComXL/36 mm']}, {'name': '32 mm femoral head', 'type': 'DEVICE', 'description': 'Stem with a 32 mm CoCr femoral head', 'armGroupLabels': ['ArComXL/32 mm', 'E-Poly/32 mm']}, {'name': '36 mm femoral head', 'type': 'DEVICE', 'description': 'Stem with a 36 mm CoCr femoral head', 'armGroupLabels': ['ArComXL/36 mm', 'E-Poly/36 mm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense C', 'state': 'Region Syddanmark', 'country': 'Denmark', 'facility': 'Joseph Abdalla Nommesen El-Sahoury', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}], 'overallOfficials': [{'name': 'Joseph Abdalla N. El-Sahoury, BSc.med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OUH Den Ortopædkirurgiske Forskningsenhed'}, {'name': 'Ming Ding, Professor MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Odense University Hospital, University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Joseph Abdalla Nommesen El-Sahoury', 'investigatorAffiliation': 'Odense University Hospital'}}}}