Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-03-06 @ 9:47 AM
Study NCT ID:
NCT03908151
Status:
TERMINATED
Last Update Posted:
2019-04-09
First Post:
2016-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Five and Ten Year Results of the CMK21 Hip System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-05', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant revision rate', 'timeFrame': '5 years', 'description': 'Listing of implant status at 5 years to analyse the survival rate'}, {'measure': 'Implant revision rate', 'timeFrame': '10 years', 'description': 'Listing of implants status at 10 years to analyse the survival rate'}, {'measure': 'Device related adverse events', 'timeFrame': '10 years', 'description': 'Medical chart will be reviewed and device related events collected to monitor the safety'}, {'measure': 'Device related adverse events', 'timeFrame': '5 and 10 years', 'description': 'Device related adverse events will be collected to monitor the safety'}, {'measure': 'Radiographic assessment', 'timeFrame': '5 and 10 Years', 'description': 'Radiolucent lines and radiosclerotic lines at both the bone cement and cement prosthesis interface'}, {'measure': 'Radiographic assessment', 'timeFrame': '5 and 10 Years', 'description': 'Position and fixation of the components'}, {'measure': 'Radiographic assessment', 'timeFrame': '5 and 10 Years', 'description': 'the occurrence of osteolysis'}, {'measure': 'Radiographic assessment', 'timeFrame': '5 and 10 Years', 'description': 'the occurrence of heterotopic bone formation'}, {'measure': 'Radiographic assessment', 'timeFrame': '5 and 10 Years', 'description': 'the occurrence of atrophy or hypertrophy'}, {'measure': 'Radiographic assessment', 'timeFrame': '5 and 10 Years', 'description': 'the occurrence of cement tears/fractures'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score (HHS)', 'timeFrame': '5 and 10 years', 'description': 'Harris Hip Score is a clinical evaluation which consists of a maximum of 100 points (best possible outcome) covering pain (1 item, 44 points), function (7 items 47 points total), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points total).'}, {'measure': 'EuroQoL Five Dimensions Questionnaire (EQ-5D)', 'timeFrame': '5 and 10 years', 'description': 'The EuroQoL Five Dimensions Questionnaire is a subject self-assessment of quality of life and consists of five questions covering the dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which subjects can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hip prosthesis'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Five and ten year results of the CMK21 Hip system', 'detailedDescription': 'This study is being conducted to collect long term retrospective and prospective clinical and radiological data to evaluate the safety of revision rate and adverse events, and efficacy of clinical and patient assessment of the CMK21 hip stem in primary total hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of all patients who received a CMK21 hip stem as part of a primary total hip arthroplasty between 2005 and 2007. This includes all diagnoses, all ages, male and female.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion:\n\n* The patients enrolled in the study were already operated at the time of the screening.\n* All the patients with osteoarthritis of the hip who received CMK21 hip stem between 2005 and 2007.\n* Skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.'}, 'identificationModule': {'nctId': 'NCT03908151', 'acronym': 'CMK21', 'briefTitle': 'Five and Ten Year Results of the CMK21 Hip System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'Five and Ten Year Results of the CMK21 Hip System', 'orgStudyIdInfo': {'id': 'R11008-2B'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CMK21 Hip system', 'type': 'DEVICE', 'description': 'Total hip arthroplasty'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asse', 'country': 'Belgium', 'facility': 'Novellas Healthcare', 'geoPoint': {'lat': 50.91011, 'lon': 4.19836}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Associatie Orthopedie Hasselt', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Beate Hanson, VP, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vice President, Global Clinical Strategy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}