[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100428385":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":27,"responsibleParty":48,"collaborators":7,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":7,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":7,"studyType":63,"phases":7,"briefSummary":64,"conditions":65,"keywords":7,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Waldemar Link GmbH & Co. KG","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Total knee replacement","Implantation of the GEMINI SL Fixed Bearing PS knee prosthesis. The operation technique of the GEMINI SL Fixed Bearing PS knee prosthesis will be followed.",[14],{"name":15,"affiliation":16,"role":17},"Julio Cesar Palacio Villegas, Dr.","Centro Medico Imbanaco Sede Principal","PRINCIPAL_INVESTIGATOR",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Kim Jacobs","CONTACT","+49 (0)40 53995866","k.jacobs@link-ortho.com",{"name":25,"role":21,"phone":7,"phoneExt":7,"email":26},"Romy Spitzmüller","r.spitzmueller@link-ortho.com",[28],{"facility":16,"status":29,"city":30,"state":31,"zip":7,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Cali","Valle del Cauca Department","Colombia","CO",{"type":35,"coordinates":36},"Point",[37,38],-76.5199,3.43054,{"lat":38,"lon":37},[41,44,45],{"name":15,"role":21,"phone":42,"phoneExt":7,"email":43},"+57 (310) 820 42 29","gruporeemplazosarticulares@gmail.com",{"name":15,"role":17,"phone":7,"phoneExt":7,"email":7},{"name":46,"role":47,"phone":7,"phoneExt":7,"email":7},"Daniel Carvajal, Dr.","SUB_INVESTIGATOR",{"type":49,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100428385","clinical-and-functional-outcome-of-the-gemini-sl-fixed-bearing-ps-knee-prosthesis-100428385",false,"NCT04858347","Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis","Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis in Short-, Mid-, and Longterm Follow-up","Inclusion Criteria:\n\n* Signed patient informed consent\n* Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis\n* Age between 18 and 80 years\n\nExclusion Criteria:\n\n* Body Mass Index (BMI) \\> 40 kg\u002Fm²\n* Foreseeable life expectancy under 5 years\n* Comorbidities and known medical circumstances which would affect the clinical or functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation\n* Patient who is mentally not able to understand the study and the study conduct\n* Patients who will be foreseeable non-compliant to the planned routine interventions and study related follow-ups\n* Prisoner\n* Pregnant women","ALL","18 Years","80 Years",{"count":61,"type":62},350,"ESTIMATED","OBSERVATIONAL","This is a prospective, multicenter, observational study with a planned follow-up period of 10 years to confirm the safety and performance of the GEMINI SL Fixed Bearing PS knee prosthesis in longterm follow-up under routine conditions. Primary outcome of the study is the 10-year survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis with revision for any reason as the endpoint.",[66],"Osteoarthrosis of Knee","2023-01-11",{"date":69,"type":70},"2023-01-12","ACTUAL",{"date":72,"type":70},"2019-07-04",{"date":74,"type":62},"2035-10",{"name":5,"class":6},1]