Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 3:39 PM
Study NCT ID:
NCT02823834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-07-08
First Post:
2016-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-15', 'releaseDate': '2024-03-11'}, {'resetDate': '2025-01-13', 'releaseDate': '2024-11-27'}], 'estimatedResultsFirstSubmitDate': '2024-03-11'}}, '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': 121}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2016-07-01', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Component Survivorship', 'timeFrame': '10 years post-operative', 'description': 'The primary objective of this study is to estimate survivorship analysis of all components at specified intervals out to 10 years follow-up.'}], 'secondaryOutcomes': [{'measure': 'Patient functional outcomes (hip specific)', 'timeFrame': '2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit', 'description': 'To characterize total functional scores, as assessed by Oxford Hip Scores'}, {'measure': 'Patient functional outcomes (quality of life)', 'timeFrame': '2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit', 'description': 'To characterize total functional scores, 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'], '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) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA 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® Gladiator Plasma Femoral Stem and PROCOTYL® L Beaded Acetabular Component', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has undergone primary THA for any of the following:\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\nPreviously implanted bilateral subjects can have both THAs enrolled in the study provided:\n\n* the specified combination of components were implanted in both\n* all other aspects of the Inclusion/Exclusion Criteria are satisfied\n* enrollment does not exceed the subject count specified in the Clinical Trial Agreement\n* the subject agrees to a second Informed Consent document specific to the second THA.\n\nExclusion Criteria:\n\n* Subjects implanted with a metal-on-metal articulation\n* Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) at the time of their primary THA in the enrolled THA\n* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery\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': 'NCT02823834', 'briefTitle': 'PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroPort Orthopedics Inc.'}, 'officialTitle': 'Post Market Clinical Follow-up Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components', 'orgStudyIdInfo': {'id': '12-LJH-002H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PROFEMUR® Gladiator Plasma Femoral Stems', 'description': 'Single study group either previously implanted with the following combination of components: PROFEMUR® Gladiator Plasma Femoral Stems, PROCOTYL® L Beaded Acetabular Shells, Polyethylene or Ceramic Liners, and Metal or Ceramic Femoral Heads.', 'interventionNames': ['Device: PROFEMUR® Gladiator Plasma Femoral Stems']}], 'interventions': [{'name': 'PROFEMUR® Gladiator Plasma Femoral Stems', 'type': 'DEVICE', 'otherNames': ['Primary hip replacement device'], 'description': 'THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components', 'armGroupLabels': ['PROFEMUR® Gladiator Plasma Femoral Stems']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21614', 'city': 'Buxtehude', 'country': 'Germany', 'facility': 'Elbe Kliniken Buxtehude', 'geoPoint': {'lat': 53.46994, 'lon': 9.68968}}], 'overallOfficials': [{'name': 'Jose Pimienta', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elbe Kliniken Buxtehude'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroPort Orthopedics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-03-11', 'type': 'RELEASE'}, {'date': '2024-08-15', 'type': 'RESET'}, {'date': '2024-11-27', 'type': 'RELEASE'}, {'date': '2025-01-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'MicroPort Orthopedics Inc.'}}}}