Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-15 @ 8:51 PM
Study NCT ID:
NCT02314702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-10-13
First Post:
2014-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-02-14', 'releaseDate': '2025-01-22'}], 'estimatedResultsFirstSubmitDate': '2025-01-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2014-12-03', 'studyFirstSubmitQcDate': '2014-12-08', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who require a revision', 'timeFrame': '10 years post-operative', 'description': 'The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up.'}], 'secondaryOutcomes': [{'measure': 'Patient functional score on the the Oxford Hip Score instrument', 'timeFrame': 'Screening (First Available), 2-5 years, 5-7 years, and 10 years', 'description': 'To characterize patient hip-related health status, as assessed by Oxford Hip Scores'}, {'measure': 'Patient functional score on the EQ-5D-3L instrument', 'timeFrame': 'Screening (First Available), 2-5 years, 5-7 years, and 10 years', 'description': 'To characterize patient general health status, as assessed by EQ-5D-3L scores'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Avascular necrosis', 'Ankylosis', 'Protrusio acetabuli', 'Painful hip dysplasia', 'Rheumatoid arthritis', 'Correction of functional deformity', 'Revision procedures'], 'conditions': ['Joint Disease']}, 'descriptionModule': {'briefSummary': 'MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been previously implanted with PROFEMUR® L Revision Femoral Components', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has undergone revision total hip arthroplasty\n* Subject is implanted with the specified combination of components\n* Subject is willing and able to complete required study visits or assessments\n\nExclusion Criteria:\n\n* Subjects currently enrolled in another clinical study\n* Subjects unwilling to sign the Informed Consent document\n* Subjects with substance abuse issues\n* Subjects who are incarcerated or have pending incarceration'}, 'identificationModule': {'nctId': 'NCT02314702', 'briefTitle': 'Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroPort Orthopedics Inc.'}, 'officialTitle': 'Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems', 'orgStudyIdInfo': {'id': '12-LJH-002L'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Revision Total Hip Arthroplasty', 'description': 'Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem', 'interventionNames': ['Device: PROFEMUR® L Revision Femoral Stem']}], 'interventions': [{'name': 'PROFEMUR® L Revision Femoral Stem', 'type': 'DEVICE', 'otherNames': ['Hip Revision Device'], 'description': 'Revision Total Hip Arthroplasty', 'armGroupLabels': ['Revision Total Hip Arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TR1 3LJ', 'city': 'Truro', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroPort Orthopedics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-01-22', 'type': 'RELEASE'}, {'date': '2025-02-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'MicroPort Orthopedics Inc.'}}}}