Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT02828293
Status:
UNKNOWN
Last Update Posted:
2019-03-06
First Post:
2016-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2016-07-01', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2D/3D videofluoroscopy', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Arthroplasty', 'Replacement, Knee']}, 'descriptionModule': {'briefSummary': 'The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA and the GMK UC Fixed Bearing TKA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '8-10 subjects with Medacta GMK Sphere TKA, 8-10 subjects with GMK PS Fixed Bearing TKA and 8-10 subjects with a GMK UC Fixed Bearing TKA will be involved in this project.\n\nThe subject recruitment will be based on the clinical reports of the follow-up examination including the standard clinical assessed parameters alignment, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the visual analog scale (VAS)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects bearing a TKA with one of the studied prosthesis\n* male and female older than 18 years old\n* patients who are willing and able to sign an informed consent form\n\nExclusion Criteria:\n\n* any case not described in the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT02828293', 'briefTitle': 'Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medacta International SA'}, 'officialTitle': 'Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy', 'orgStudyIdInfo': {'id': 'P02.014.11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GMK Sphere', 'description': 'Patients who underwent total knee replacement using GMK Sphere implants. Patients underwent surgery before the inclusion in the study.', 'interventionNames': ['Other: Dynamic videofluoroscopic analysis']}, {'label': 'GMK PS Fixed Bearing', 'description': 'Patients who underwent total knee replacement using GMK PS Fixed Bearing implants. Patients underwent surgery before the inclusion in the study.', 'interventionNames': ['Other: Dynamic videofluoroscopic analysis']}, {'label': 'GMK UC Fixed Bearing', 'description': 'Patients who underwent total knee replacement using GMK UC Fixed Bearing implants. Patients underwent surgery before the inclusion in the study.', 'interventionNames': ['Other: Dynamic videofluoroscopic analysis']}], 'interventions': [{'name': 'Dynamic videofluoroscopic analysis', 'type': 'OTHER', 'description': 'Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.', 'armGroupLabels': ['GMK PS Fixed Bearing', 'GMK Sphere', 'GMK UC Fixed Bearing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-8092', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Renate List', 'role': 'CONTACT', 'email': 'rlist@ethz.ch'}], 'facility': 'Institute for Biomechanics ETH Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'CH-8092', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'William Taylor', 'role': 'CONTACT', 'phone': '+41 44 632 2354'}], 'facility': 'Institute for Biomechanics ETH Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medacta International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}