Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT03897595
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess the Mid-term Performance of the Mpact Cup in Subjects Requiring Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-28', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Harris Hip Scores (HHS)', 'timeFrame': 'Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year', 'description': 'Assessment of improvement of clinical outcomes following total hip replacement surgery using the Harris Hip Scores'}, {'measure': 'Change from baseline of implant survivorship', 'timeFrame': 'Post-operative 3 or 6 months, 1 year, 2 year, and 5 year', 'description': 'Assessment of bone fracture, implant fracture, neck reabsorption'}, {'measure': 'Change in baseline of Complications', 'timeFrame': 'Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year.', 'description': 'Assessment of Adverse events and serious adverse events'}, {'measure': 'Change in baseline fixation and wear', 'timeFrame': 'Post-operative 3 or 6 months, 1 year, 2 year and 5 year', 'description': 'Radiographic analysis by measuring Radio Lucent Lines'}, {'measure': 'Change in baseline fixation', 'timeFrame': 'Post-operative 3 or 6 months, 1 year, 2 year and 5 year', 'description': 'Radiographic analysis by measuring implant fixation in millimeters'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hip Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, '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\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': 'NCT03897595', 'briefTitle': 'Assess the Mid-term Performance of the Mpact Cup in Subjects Requiring Total Hip Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta USA'}, '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': 'P01.014.08/01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mpact cup', 'description': 'Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head', 'interventionNames': ['Device: MPact Cup']}], 'interventions': [{'name': 'MPact Cup', 'type': 'DEVICE', 'description': 'Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head', 'armGroupLabels': ['Mpact cup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80134', 'city': 'Parker', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Vail Orthopedics', 'geoPoint': {'lat': 39.5186, 'lon': -104.76136}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saint Alphonsus Medical Group', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60048', 'city': 'Libertyville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Bone and Joint Institute', 'geoPoint': {'lat': 42.28308, 'lon': -87.95313}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'McBride Orthopedic Hospital', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}