Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT00867256
Status:
TERMINATED
Last Update Posted:
2023-09-22
First Post:
2008-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'whyStopped': 'terminated for business reasons; study closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2009-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2008-04-07', 'studyFirstSubmitQcDate': '2009-03-19', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite clinical criterion', 'timeFrame': '24-months postoperative', 'description': 'Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['arthritis'], 'conditions': ['Osteoarthritis', 'Rheumatoid Arthritis', 'Avascular Necrosis']}, 'descriptionModule': {'briefSummary': 'To demonstrate the safety and efficacy of the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System using a composite clinical success (CCS) primary endpoint.', 'detailedDescription': 'The results from the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System cohort will be compared to the historical results from a ceramic on ceramic (CoC) hip system cohort. The primary endpoint clinical composite success (CCS) criterion at 24 months postoperative is based on a Harris Hip Score ≥ 80 and the absence of any revision,replacement, or modification of any study component.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\nPatient:\n\n* is skeletally mature\n* is mentally capable of completing follow-up forms\n* will be available for follow-up out to 2 years\n* has a preoperative Harris Hip Score \\<70 points\n* has been deemed a candidate for hip replacement by diagnosis of the investigator.\n\nEXCLUSION CRITERIA:\n\nPatient:\n\n* has active joint infection\n* has had previous hip arthrodesis (fusion)\n* has had above knee amputation of either extremity\n* has active neoplastic disease\n* has a need for a structural bone graft in the operative side\n* has an ipsilateral hemi or total arthroplasty of any kind\n* has a nonunion or malunion of any part of the femur on operative side\n* has severe osteoporosis of the pelvis and/or femur as noted on standard radiograph\n* is a prisoner\n* is pregnant\n* is known to be allergic to implant materials\n* is morbidly obese.'}, 'identificationModule': {'nctId': 'NCT00867256', 'briefTitle': 'Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corin'}, 'officialTitle': 'Large Diameter Metal-on-Metal Total Hip System IDE', 'orgStudyIdInfo': {'id': 'LDMOM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Large Diameter Metal on Metal', 'interventionNames': ['Device: Large Diameter Metal on Metal']}], 'interventions': [{'name': 'Large Diameter Metal on Metal', 'type': 'DEVICE', 'armGroupLabels': ['Large Diameter Metal on Metal']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giulia Carli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corin Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corin', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}