Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-27 @ 4:30 AM
Study NCT ID:
NCT02262468
Status:
COMPLETED
Last Update Posted:
2014-10-13
First Post:
2014-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Warwick Metal On Metal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-10', 'studyFirstSubmitDate': '2014-10-07', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxford hip score', 'timeFrame': '6 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['retrospective analysis'], 'conditions': ['Metal Hip Replacement']}, 'descriptionModule': {'briefSummary': 'assess results of metal on metal hip replacements carried out at warwick hospital', 'detailedDescription': 'Resurfacing and XL head hip replacements have not done as well as expected. The ASR implant has been withdrawn. Recent publications and media appearances by Tony Nargol, an orthopaedic surgeon, have suggested 36mm metal on metal replacements. I intend to report the results of this series.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with 36mm metal on metal hips', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with 36mm metal on metal hips\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02262468', 'briefTitle': 'Warwick Metal On Metal Study', 'organization': {'class': 'OTHER', 'fullName': 'South Warwickshire NHS Foundation Trust'}, 'officialTitle': 'Review of 750 36mm MOM Hip Replacements ( Pinnacle/Corail) With up to 6 Year Follow up', 'orgStudyIdInfo': {'id': 'IIS2012012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MOM total hip replacements', 'description': 'all patients with MOM 36mm hip replacements', 'interventionNames': ['Radiation: x ray']}], 'interventions': [{'name': 'x ray', 'type': 'RADIATION', 'armGroupLabels': ['MOM total hip replacements']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Warwickshire NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'DePuy International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'consultant orthopaedic surgeon', 'investigatorFullName': 'Stephen Young', 'investigatorAffiliation': 'South Warwickshire NHS Foundation Trust'}}}}