Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT02829866
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2016-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMIStem-H Radiographic Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2016-07-05', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological analysis of radiolucency lines presence according to Gruen zone classification', 'timeFrame': '5 year'}], 'secondaryOutcomes': [{'measure': 'radiological assessment of femoral deformation', 'timeFrame': '5 year, 10 year'}, {'measure': 'radiological assessment of femoral stem subsidence', 'timeFrame': '5 year, 10 year'}, {'measure': 'radiological assessment of cortical bone density', 'timeFrame': '5 year, 10 year'}, {'measure': 'radiological assessment of calcar resorption', 'timeFrame': '5 year, 10 year'}, {'measure': 'Radiological analysis of radiolucency lines presence according to Gruen zone classification', 'timeFrame': '10 year'}]}, 'conditionsModule': {'conditions': ['Arthroplasty', 'Replacement', 'Hip']}, 'descriptionModule': {'briefSummary': 'Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are constantly looking to improve all aspects related to this procedure weather is improvement of implant design, instrumentation or surgical technique. Excellent clinical and radiological results were observed at medium and long term in the last years for AMIStem system.\n\nThis observational study has the objective to survey hip prosthesis stability and function of the operated hip in patients who are not exposed to surgical risks. The principal investigator will contact all patients in order to perform the follow-up visit according to standard practice. Patients operated between January 2010 and December 2011 will be invited in the study during the clinical visit organised according to standard practice. Preoperative clinical and radiological data, intraoperative details and postoperative follow-up data at 1-year will be retrospectively collected. Five-year and ten-year data will be prospectively collected after inclusion in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received a total hip arthroplasty with AMIStem H between January 2010 and December 2011 will be invited to participate in the study during the visit at 5 years previewed by standard practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient who has received a total hip arthroplasty between January 2010 and December 2011\n2. Patient who has received an AMIStem H femoral component\n3. Patient who have signed the information letter in order to give agreement for the clinical data treatment\n\nExclusion Criteria:\n\n1. Minor patient\n2. Pregnant or breast feeding woman\n3. Any patient who cannot or will not provide informed consent for participation in the study'}, 'identificationModule': {'nctId': 'NCT02829866', 'briefTitle': 'AMIStem-H Radiographic Analysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'THP AMIStem-H: Open, Retrospective and Prospective, Monocentric, Non Randomised Observational Study', 'orgStudyIdInfo': {'id': 'P01.001.11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AMIStem-H', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8400', 'city': 'Winterthur', 'country': 'Switzerland', 'facility': 'Kantonspital Winthertur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}