[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646876":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":7,"responsibleParty":27,"collaborators":7,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":35,"eligibilityCriteria":36,"healthyVolunteers":31,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":7,"studyType":43,"phases":7,"briefSummary":44,"conditions":45,"keywords":50,"overallStatus":55,"whyStopped":7,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":7},{"fullName":5,"class":6},"Aesculap AG","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","oneKNEE®","Total knee prostheses",[14],{"name":15,"affiliation":16,"role":17},"Anne Postler, PD Dr. med","Städt. Klinikum Dresden","PRINCIPAL_INVESTIGATOR",[19,25],{"name":20,"role":21,"phone":22,"phoneExt":23,"email":24},"Heike Oberascher","CONTACT","+49 7461 95","0","studies@aesculap.de",{"name":26,"role":21,"phone":22,"phoneExt":23,"email":24},"Stefan Maenz, Dr.",{"type":28,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100646876","prospective-non-interventional-multicenter-post-market-clinical-follow-up-study-100646876",false,"NCT07682909","oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study","oneKNEE - Prospective, Non-interventional, Multicenter Post-Market Clinical Follow-Up Study","oneKNEE","Inclusion Criteria:\n\n* Patient age ≤ 80 years\n* Indication for a total knee replacement with one of the variants\n* Written informed consent\n* Willingness and mental ability to participate at the long-term follow-up examinations\n\nExclusion Criteria:\n\n* Contraindications acc. to the Instructions for Use (IFU)\n* Patient age \\\u003C 18 years\n* Known pregnancy\n* BMI \\> 40\n* Secondary gonarthrosis (e.g. rheumatoid arthritis, post-traumatic)\n* Patients classified as high risk (ASA class \\>3)\n* Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy\n* Preoperative: aHKA \\> 190° or aHKA \\\u003C 170°\n* Preoperative: aHKA \\> 190° or aHKA \\\u003C 170°\\[KB1.1\\]\\[HO1.2\\]\\[KB1.3\\]\\[HO1.4\\]\n* Patients held in a custodial setting und - Patients in a relationship of dependence on the sponsor, the clinic or the investigator","ALL","18 Years","79 Years",{"count":41,"type":42},1020,"ESTIMATED","OBSERVATIONAL","Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.",[46,47,48,49],"Arthroplasty","Arthroplasty Replacement, Knee","Prosthetic Joint Infections of Knee","TKA Outcomes",[51,52,53,54],"Total Knee Arthroplasty","Safety and Clinical Performance","oneKnee","Integrated platform of knee implants and instruments","NOT_YET_RECRUITING","2026-08-12",{"date":58,"type":59},"2026-08-14","ACTUAL",{"date":61,"type":42},"2027-04",{"date":63,"type":42},"2031-12",{"name":5,"class":6}]