Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT02149667
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-07
First Post:
2014-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-up Study Protocol for DYNASTY® BioFoam® 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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2014-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Component Survivorship', 'timeFrame': '10 years post-operative', 'description': 'The primary objective of this study is to estimate component survivorship of all components out to 10 years follow-up.'}], 'secondaryOutcomes': [{'measure': 'Patient functional outcomes', 'timeFrame': 'Screening (First Available), 2-5 years, 5-7 years, and 10 years', 'description': 'The secondary objective is to characterize total functional scores, as assessed by HOOS Scores and 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': 'Sponsor 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 MEDDEV 2.12/2 rev 2.', 'detailedDescription': 'Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients previously implanted with DYNASTY® BioFoam® Acetabular Components', '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, and painful hip dysplasia\n* Inflammatory degenerative joint disease such as rheumatoid arthritis\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* Skeletally immature (less than 21 years of age at time of 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 have pending incarceration'}, 'identificationModule': {'nctId': 'NCT02149667', 'briefTitle': 'Post Market Clinical Follow-up Study Protocol for DYNASTY® BioFoam® Acetabular Components', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroPort Orthopedics Inc.'}, 'officialTitle': 'Post Market Clinical Follow-up Study Protocol for DYNASTY® BioFoam® Acetabular Components', 'orgStudyIdInfo': {'id': '12-LJH-002C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total Hip Arthroplasty', 'description': 'Single study group previously implanted with the following combination of components: MicroPort Orthopedics Femoral Stems, DYNASTY® BioFoam® Acetabular Components, DYNASTY® A-Class® Cross Linked Polyethylene Liners, and MicroPort Orthopedics Metal or Ceramic Femoral Heads', 'interventionNames': ['Device: total hip arthroplasty implant']}], 'interventions': [{'name': 'total hip arthroplasty implant', 'type': 'DEVICE', 'otherNames': ['DYNASTY® BioFoam® Acetabular Components,', 'DYNASTY® A-Class® Cross Linked Polyethylene Liners'], 'armGroupLabels': ['Total Hip Arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Paul Beaule, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroPort Orthopedics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}