Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-02-08 @ 12:59 AM
Study NCT ID:
NCT02196818
Status:
TERMINATED
Last Update Posted:
2023-03-22
First Post:
2014-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D006618', 'term': 'Hip Dislocation, Congenital'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D000082602', 'term': 'Developmental Dysplasia of the Hip'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "Study was closed mainly because the surgeons participating no longer had the infrastructure to support the research and weren't following their subjects", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2014-07-07', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Kaplan-Meier analysis as a measure of implant performance.', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'The Harris Hip Score.', 'timeFrame': 'pre-op, 3/6 months, 1,2 and 5 years'}, {'measure': 'Radiological analysis as a meausure of safety.', 'timeFrame': '3/6 months, 1,2 and 5 years'}]}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Arthritis', 'Avascular Necrosis', 'Fracture of the Femoral Neck or Head', 'Congenital Hip Dysplasia']}, 'descriptionModule': {'briefSummary': 'This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary total hip arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.\n* Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).\n* Patients must be willing to comply with the pre and post-operative evaluation schedule.\n\nExclusion Criteria:\n\n* Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study."}, 'identificationModule': {'nctId': 'NCT02196818', 'briefTitle': 'A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'P01.014.08/00'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mpact Acetabular Shell', 'description': 'Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.', 'interventionNames': ['Device: Mpact Acetabular Shell']}], 'interventions': [{'name': 'Mpact Acetabular Shell', 'type': 'DEVICE', 'description': 'Total Hip Replacement', 'armGroupLabels': ['Mpact Acetabular Shell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Vail Orthopedics, P.C.', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saint Alphonsus Regional Medical Center', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60048', 'city': 'Libertyville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Bone & Joint Institute, LLC', 'geoPoint': {'lat': 42.28308, 'lon': -87.95313}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Jordan Valley Medical Center', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}