[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589520":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":99,"collaborators":101,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":10,"studyType":118,"phases":10,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Aesculap AG","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"pheno4u TKA Level 1",null,"Navigation of TKA (Total Knee Arthroplasty) using the new pheno4uTKA Level 1 software for OrthoPilot Elite®.",[13],"Procedure: Navigated Total Knee Arthroplasty",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Navigated Total Knee Arthroplasty","The OrthoPilot® Software Pheno4u TKA Level 1 is an application software for computer aided navigation of surgical instruments and serves (in combination with compatible hardware and compatible navigated instruments) as an optional aid for the surgeon during the preparation of the implant site for a compatible knee endoprosthesis.",[9],[21],{"name":22,"affiliation":23,"role":24},"Jörg Lützner, Prof. Dr.","Universitätsklinikum Carl Gustav Carus","PRINCIPAL_INVESTIGATOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Heike Oberascher","CONTACT","+49 7461 95","0","studies@aesculap.de",{"name":33,"role":28,"phone":29,"phoneExt":30,"email":31},"Stefan Maenz, Dr.",[35,54,72,87],{"facility":36,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":10,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Šumperk Hospital Inc.","NOT_YET_RECRUITING","Šumperk","78701","Czechia",{"type":42,"coordinates":43},"Point",[44,45],16.97061,49.96528,{"lat":45,"lon":44},[48,50,52],{"name":49,"role":28,"phone":10,"phoneExt":10,"email":10},"Ján Debre, Dr.med",{"name":10,"role":28,"phone":51,"phoneExt":30,"email":10},"+420 583 333",{"name":53,"role":24,"phone":10,"phoneExt":10,"email":10},"Ján Debre, Dr. med",{"facility":55,"status":37,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Klinikum Konstanz GmbH","Konstanz","Baden-Wurttemberg","78464","Germany","DE",{"type":42,"coordinates":62},[63,64],9.17582,47.66033,{"lat":64,"lon":63},[67,70],{"name":68,"role":28,"phone":69,"phoneExt":30,"email":10},"Gunnar Ochs, Prof.Dr.med","+49 7531 801",{"name":71,"role":24,"phone":10,"phoneExt":10,"email":10},"Gunnar Ochs, Prof. Dr.",{"facility":73,"status":74,"city":75,"state":10,"zip":76,"country":59,"countryCode":60,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Park-Klinik Weißensee","RECRUITING","Berlin","13086",{"type":42,"coordinates":78},[79,80],13.41053,52.52437,{"lat":80,"lon":79},[83,85],{"name":84,"role":28,"phone":69,"phoneExt":30,"email":10},"Oliver Hauschild, Prof.Dr.med",{"name":86,"role":24,"phone":10,"phoneExt":10,"email":10},"Oliver Hauschild, Prof. Dr.",{"facility":23,"status":37,"city":88,"state":10,"zip":89,"country":59,"countryCode":60,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Dresden","01307",{"type":42,"coordinates":91},[92,93],13.73832,51.05089,{"lat":93,"lon":92},[96,98],{"name":22,"role":28,"phone":97,"phoneExt":30,"email":10},"+49 351 458 150",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"type":100,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[102],{"name":103,"class":6},"Raylytic GmbH","100589520","study-to-evaluate-the-performance-of-navigated-tka-with-orthopilot-pheno4u-tka-level-1-100589520",false,"NCT06955481","Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1","Prospective, Single-arm, Multicenter Study to Evaluate the Performance of Navigated Total Knee Arthroplasty Using the OrthoPilot and the Software pheno4u TKA Level 1","TKA4U","Inclusion Criteria:\n\n* Indication for a TKA with the OrthoPilot® Navigation System with a Aesculap total knee endo-prosthesis\n* Written signed informed consent of patient\n* Willingness and mental ability to participate at the long-term follow-up examinations\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients \\\u003C 18 years or \\> 80 years\n* Patients unable to participate at the follow-up examination (physically, mentally)\n* Previous joint replacement at the index knee\n* ASA classification \\> 3 ( ASA I: A healthy patient without systemic diseases. ASA II: A patient with a mild systemic disease that is well controlled (e.g., well-controlled diabetes or hypertension). ASA III: A patient with a severe systemic disease that causes functional limitations (e.g., poorly controlled diabetes, COPD). ASA IV: A patient with a life-threatening systemic disease (e.g., severe heart failure, sepsis). ASA V: A dying patient who is not expected to survive without the operation. ASA VI: A deceased patient whose organs are being removed for donation.)","ALL","18 Years","80 Years",{"count":116,"type":117},120,"ESTIMATED","OBSERVATIONAL","The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance.\n\nPatient-related outcome measures (PROM) will be acquired to investigate functional outcome and patient satisfaction.",[121,122,123,124],"Osteoarthritis, Knee","Joint Diseases","Rheumatoid Arthritis of Knee","Posttraumatic Arthropathy",[126,127,128],"Navigation","Total Knee Arthroplasty","OrthoPilot","2025-11-14",{"date":131,"type":132},"2025-11-17","ACTUAL",{"date":134,"type":132},"2025-10-07",{"date":136,"type":117},"2028-06",{"name":5,"class":6},4]