Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-29 @ 4:21 PM
Study NCT ID:
NCT06518993
Status:
TERMINATED
Last Update Posted:
2025-07-09
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Collect Safety Data and PROMs on Primary THA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D005265', 'term': 'Femoral Neck Fractures'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The current study was prematurely terminated as part of a strategic decision to consolidate resources and incorporate the Trinity implant into another ongoing PMCF study which was initiated to meet updated regulatory requirements.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-19', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of hip functional performance', 'timeFrame': '2 years', 'description': 'Improvement of Oxford Hip Score (OHS)'}], 'secondaryOutcomes': [{'measure': 'Confirmation of safety of the study devices', 'timeFrame': '2 years', 'description': 'Number, severity and causal relationship procedure of implant-related adverse events'}, {'measure': 'Evaluation of outcome after hip arthroplasty', 'timeFrame': '2 years', 'description': 'Number, severity and causal relationship procedure of implant-related adverse events'}, {'measure': 'Evaluation of clinical outcomes', 'timeFrame': '2 years', 'description': 'Improvement of Harris Hip Score (HHS)'}, {'measure': 'Assessment of health-related quality of life', 'timeFrame': '2 years', 'description': 'Change of EQ-5D-5L'}, {'measure': "Assessment of patient's satisfaction", 'timeFrame': '2 years', 'description': "Improvement of patient's satisfaction following surgery using Self-Administered Patient Satisfaction Scale"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total hip arthroplasty'], 'conditions': ['Hip Arthritis', 'Osteoarthritis, Hip', 'Coxitis', 'Femoral Head Necrosis', 'Femoral Neck Fractures']}, 'descriptionModule': {'briefSummary': 'This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system', 'detailedDescription': 'The major goal of this study is to collect safety and patient-reported outcomes measures (PROMs) data on Trinity cup in combination with Meije Duo cementless hip stem when used in primary total hip arthroplasty (THA).\n\nData collected from this study will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses and/or peer-reviewed publication(s) on mid- and long-term safety and clinical performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have undergone to a THA with Trinity cup and Meije Duo cementless hip will be invited to participate in this study. An initial review of the medical database of all Corin Trinity cup procedures performed in the selected study site will be conducted to assess the number of retrospective patients potentially available to join the study. A first contact with the patient will occur telephonically or via mail to explain the study and invite them to join.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders.\n* Adult subjects.\n* Subjects who received a primary THR with Trinity cup and Meije Duo cementless femoral stem.\n* The subject is willing to comply with the required follow-up visits as per protocol.\n* The subject has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.\n\nExclusion Criteria:\n\n* Subjects under guardianship.\n* Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.'}, 'identificationModule': {'nctId': 'NCT06518993', 'briefTitle': 'Observational Study to Collect Safety Data and PROMs on Primary THA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corin'}, 'officialTitle': 'Observational Study to Collect Safety Data and Patient-reported Outcomes Measures (PROMs) on Retrospective Primary Total Hip Arthroplasty Surgeries With Trinity Cup and Meije Duo Cementless Hip Stem', 'orgStudyIdInfo': {'id': 'CSP2022-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem', 'type': 'DEVICE', 'description': 'Subjects clinically suitable for a primary THR surgery with Trinity cup and Meije Duo cementless femoral stem.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59300', 'city': 'Valenciennes', 'country': 'France', 'facility': 'CH Valenciennes', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}], 'overallOfficials': [{'name': 'Charles BERTON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH VALENCIENNES'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corin', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}