Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 10:49 PM
Study NCT ID:
NCT00721994
Status:
COMPLETED
Last Update Posted:
2018-11-21
First Post:
2008-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-09-03', 'releaseDate': '2021-08-10'}], 'estimatedResultsFirstSubmitDate': '2021-08-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood specimens for metal ion testing and renal function testing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-20', 'studyFirstSubmitDate': '2008-07-23', 'studyFirstSubmitQcDate': '2008-07-24', 'lastUpdatePostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score components including total score, pain, function and range of motion', 'timeFrame': '10 years'}, {'measure': 'device survival', 'timeFrame': '10 years'}, {'measure': 'device related adverse events', 'timeFrame': '10 years'}, {'measure': 'radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt', 'timeFrame': '10 years'}, {'measure': 'whole blood trace metals and renal function', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hip resurfacing', 'osteoarthritis', 'avascular necrosis', 'rheumatoid arthritis'], 'conditions': ['Osteoarthritis', 'Avascular Necrosis', 'Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.', 'detailedDescription': 'Maintaining "at least good clinical status" will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'IDE study subjects at 5 IDE study sites', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects enrolled in the Cormet IDE study at the 5 identified clinical sites\n* Individuals who agree to participate in the study by signing the informed patient consent form\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00721994', 'acronym': 'PAS:IDE', 'briefTitle': 'Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corin'}, 'officialTitle': 'Cormet Resurfacing Hip System Post PMA Approval Study (PMA #P050016)Pre-market (IDE) Study Group 10 Year Follow-Up With Metal Ion and Renal Function Data Collection Clinical Investigation Plan', 'orgStudyIdInfo': {'id': 'PAS: IDE subjects'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'IDE subjects who received the Cormet Hip Resurfacing device', 'interventionNames': ['Device: Cormet Hip Resurfacing System']}], 'interventions': [{'name': 'Cormet Hip Resurfacing System', 'type': 'DEVICE', 'otherNames': ['Corin Cormet'], 'description': 'Cormet Hip Resurfacing System', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32953', 'city': 'Merritt Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Space Coast Orthopaedics Ctr.', 'geoPoint': {'lat': 28.359, 'lon': -80.69}}, {'zip': '34233', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Kennedy White Orthopedics', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '21239', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '44113', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Center for Joint Reconstruction', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Kathy Trier, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corin', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-08-10', 'type': 'RELEASE'}, {'date': '2021-09-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Corin'}}}}