Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-12 @ 4:19 PM
Study NCT ID:
NCT02507258
Status:
WITHDRAWN
Last Update Posted:
2018-06-07
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D000844', 'term': 'Ankylosis'}], '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': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sponsor decision to not renew CE mark on product. Therefore study not needed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2018-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Component Survivorship', 'timeFrame': '10 years post-operative', 'description': 'The primary objective of this study is to estimate survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device.'}], 'secondaryOutcomes': [{'measure': 'Patient functional outcomes (hip specific)', 'timeFrame': 'Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval', 'description': 'To characterize total functional scores, as assessed by Oxford Hip and EQ-5D-3L scores'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'avascular necrosis', 'correction of functional deformity', 'painful hip dysplasia', 'protrusio acetabuli', 'rheumatoid arthritis', 'ankylosis'], 'conditions': ['Joint Disease']}, 'descriptionModule': {'briefSummary': 'MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (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 the medial device directives (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 a PROFEMUR® Am Femoral Stem and PROCOTYL® O HA-Coated Acetabular Component', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubject has undergone primary THA for any of the following:\n\n* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;\n* Inflammatory degenerative joint disease such as rheumatoid arthritis; or\n* Correction of functional deformity\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 skeletally immature (less than 21 years of age) at time of primary THA surgery\n* Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA\n* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol\n* Subjects unwilling to sign the Informed Consent document\n* Subjects with substance abuse issues\n* Subjects who are incarcerated or having pending incarceration'}, 'identificationModule': {'nctId': 'NCT02507258', 'briefTitle': 'PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroPort Orthopedics Inc.'}, 'officialTitle': 'Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components', 'orgStudyIdInfo': {'id': '12-LJH-002K'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PROFEMUR® Am Femoral Stem', 'description': 'Single study group previously implanted with a primary PROFEMUR® Am Femoral Stem and PROCOTYL® O HA Coated Acetabular Component', 'interventionNames': ['Device: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell']}], 'interventions': [{'name': 'PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell', 'type': 'DEVICE', 'description': 'PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component', 'armGroupLabels': ['PROFEMUR® Am Femoral Stem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hopital Joseph Ducuing', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Gérard Giordano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Joseph Ducuing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroPort Orthopedics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}