[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474595":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":75,"collaborators":7,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":7,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":7,"studyType":90,"phases":7,"briefSummary":91,"conditions":92,"keywords":7,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"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",[20,35,49,62],{"facility":21,"status":22,"city":23,"state":7,"zip":7,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Centre de l'Arthrose","RECRUITING","Mérignac","France","FR",{"type":27,"coordinates":28},"Point",[29,30],-0.64512,44.84247,{"lat":30,"lon":29},[33],{"name":34,"role":16,"phone":7,"phoneExt":7,"email":7},"Charles RIVIERE",{"facility":36,"status":22,"city":37,"state":7,"zip":38,"country":24,"countryCode":25,"cosmosGeoPoint":39,"geoPoint":43,"contacts":44},"Clinique de l'Union","Saint-Jean","31240",{"type":27,"coordinates":40},[41,42],1.50459,43.66519,{"lat":42,"lon":41},[45],{"name":46,"role":16,"phone":47,"phoneExt":7,"email":48},"David BENZAQUEN, Dr.","+33 05 61 37 87 79","davidbenzaquen@icloud.com",{"facility":50,"status":22,"city":51,"state":7,"zip":7,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Humanitas Castelli","Bergamo","Italy","IT",{"type":27,"coordinates":55},[56,57],9.66721,45.69601,{"lat":57,"lon":56},[60],{"name":61,"role":16,"phone":7,"phoneExt":7,"email":7},"Vincenzo Madonna",{"facility":63,"status":22,"city":64,"state":7,"zip":7,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Gelenkzentrum Winterthur","Winterthur","Switzerland","CH",{"type":27,"coordinates":68},[69,70],8.72413,47.50564,{"lat":70,"lon":69},[73],{"name":74,"role":16,"phone":7,"phoneExt":7,"email":7},"Peter Koch",{"type":76,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100474595","the-medacta-gmk-spherika-post-marketing-surveillance-study-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":88,"type":89},281,"ESTIMATED","OBSERVATIONAL","This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.",[93,94],"Arthropathy","Knee Replacement","2025-09-23",{"date":97,"type":98},"2025-09-29","ACTUAL",{"date":100,"type":98},"2022-07-30",{"date":102,"type":89},"2035-05",{"name":5,"class":6},4]