[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474595":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":72,"collaborators":7,"id":74,"slug":7,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":7,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":7,"studyType":86,"phases":7,"briefSummary":87,"conditions":88,"keywords":7,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Medacta International SA","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","GMK SpheriKA","The first objective is to study the FJS of patients who were implanted a \"GMK® SpheriKA\" knee prosthesis using the kinematic alignment technique",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Arianna Girardi","CONTACT","+41 91 696 60 60","girardi@medacta.ch",[20,34,48,60],{"facility":21,"status":22,"city":23,"state":7,"zip":7,"country":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":31},"Centre de l'Arthrose","RECRUITING","Mérignac","France",{"type":26,"coordinates":27},"Point",[28,29],-0.64512,44.84247,{"lat":29,"lon":28},[32],{"name":33,"role":16,"phone":7,"phoneExt":7,"email":7},"Charles RIVIERE",{"facility":35,"status":22,"city":36,"state":7,"zip":37,"country":24,"cosmosGeoPoint":38,"geoPoint":42,"contacts":43},"Clinique de l'Union","Saint-Jean","31240",{"type":26,"coordinates":39},[40,41],1.50459,43.66519,{"lat":41,"lon":40},[44],{"name":45,"role":16,"phone":46,"phoneExt":7,"email":47},"David BENZAQUEN, Dr.","+33 05 61 37 87 79","davidbenzaquen@icloud.com",{"facility":49,"status":22,"city":50,"state":7,"zip":7,"country":51,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Humanitas Castelli","Bergamo","Italy",{"type":26,"coordinates":53},[54,55],9.66721,45.69601,{"lat":55,"lon":54},[58],{"name":59,"role":16,"phone":7,"phoneExt":7,"email":7},"Vincenzo Madonna",{"facility":61,"status":22,"city":62,"state":7,"zip":7,"country":63,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Gelenkzentrum Winterthur","Winterthur","Switzerland",{"type":26,"coordinates":65},[66,67],8.72413,47.50564,{"lat":67,"lon":66},[70],{"name":71,"role":16,"phone":7,"phoneExt":7,"email":7},"Peter Koch",{"type":73,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100474595",false,"NCT05459948","The Medacta GMK SpheriKA Post-Marketing Surveillance Study","Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study","Inclusion Criteria:\n\n* Patients willing to sign the informed consent.\n* Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.\n* Patients 18 - 80 years of age at the time of surgery.\n* Patients requiring a primary total knee replacement (on label use).\n* Patients with intact collateral ligaments.\n\nExclusion Criteria:\n\n* Patients with inflammatory arthritis.\n* Morbidly obese patients, with a body mass index (BMI) \\> 40.\n* Patients with a history of total or unicompartmental reconstruction of the affected joint.\n* Patients that have had a high tibial osteotomy or femoral osteotomy.\n* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.\n* Patients with a systemic or metabolic disorder leading to progressive bone deterioration.\n* Patients that are immunologically compromised or receiving chronic steroids (\\> 30 days).\n* Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and\u002For fixation to the prosthesis.\n* Patients with an active or suspected latent infection in or surrounding the knee joint.\n* Pregnant or breastfeeding women.","ALL","18 Years","80 Years",{"count":84,"type":85},281,"ESTIMATED","OBSERVATIONAL","This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.",[89,90],"Arthropathy","Knee Replacement","2025-09-23",{"date":93,"type":94},"2025-09-29","ACTUAL",{"date":96,"type":94},"2022-07-30",{"date":98,"type":85},"2035-05",{"name":5,"class":6},4]