[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463422":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":26,"locations":32,"responsibleParty":83,"collaborators":10,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":10,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":10,"enrollmentInfo":94,"targetDuration":10,"studyType":97,"phases":10,"briefSummary":98,"conditions":99,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Limacorporate S.p.a","INDUSTRY",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Multigen Plus CCK",null,[12],"Device: Multigen Plus CCK",{"label":14,"type":10,"description":10,"interventionNames":15},"Multigen Plus CCK in combination with AMF TT cones",[12,16],"Device: AMF TT cones",[18,22],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":10},"DEVICE","Total Knee Arthroplasty",[9,14],{"type":19,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"AMF TT cones","To fill a proximal tibia or distal femur defect",[14],[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Francesca Citossi, CIS Manager Europe & APAC","CONTACT","+39 335 1640260","francesca.citossi@limacorporate.com",[33,52,67],{"facility":34,"status":35,"city":36,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hospital Senhora da Oliveira in Guimarães","RECRUITING","Guimarães","Portugal","PT",{"type":40,"coordinates":41},"Point",[42,43],-8.29619,41.44443,{"lat":43,"lon":42},[46,49],{"name":47,"role":29,"phone":10,"phoneExt":10,"email":48},"Ms Daniela Batista","Daniela Batista \u003Cdaniela.batista@blueclinical.pt>",{"name":50,"role":51,"phone":10,"phoneExt":10,"email":10},"Carlos Vilela","PRINCIPAL_INVESTIGATOR",{"facility":53,"status":35,"city":54,"state":10,"zip":10,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Saints Cyril and Methodius Hospital","Bratislava","Slovakia","SK",{"type":40,"coordinates":58},[59,60],17.10674,48.14816,{"lat":60,"lon":59},[63,66],{"name":64,"role":29,"phone":10,"phoneExt":10,"email":65},"Boris Šteňo","steno@pe.unb.sk",{"name":64,"role":51,"phone":10,"phoneExt":10,"email":10},{"facility":68,"status":35,"city":69,"state":10,"zip":10,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Royal Devon and Exeter Hospital","Exeter","United Kingdom","UK",{"type":40,"coordinates":73},[74,75],-3.52751,50.7236,{"lat":75,"lon":74},[78,81],{"name":79,"role":29,"phone":10,"phoneExt":10,"email":80},"Sadie Heddon","sadie.heddon@nhs.net",{"name":82,"role":51,"phone":10,"phoneExt":10,"email":10},"Jonathan Phillips",{"type":84,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100463422","multigen-plus-cck-and-amf-tt-cones-follow-up-study-100463422",false,"NCT05314491","Multigen Plus CCK and AMF TT Cones Follow Up Study","A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Total Knee Arthroplasty With Multigen Plus CCK Alone or Involving the AMF TT Cones.","Inclusion Criteria:\n\n* Male or female.\n* Age ≥ 18 years old.\n* Given written informed consent approved by the reference Ethics Committee (EC).\n* Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with Multigen Plus system as per Indication For Use. The decision to implant a Multigen Plus CCK system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.\n* Subjects able to comply with the Study Protocol.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old.\n* Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus CCK, as reported in the current Instruction For Use.\n* Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.\n* Female subjects who are pregnant, nursing, or planning a pregnancy.\n* Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS \\\u003C 70 points.","ALL","18 Years",{"count":95,"type":96},68,"ESTIMATED","OBSERVATIONAL","This study is aimed to provide a clinical and radiographic evaluation of 68 condylar-constrained Total Knee Arthroplasty (TKA) using a single type of prosthesis (Multigen Plus CCK configuration), alone or involving the AMF TT cones, in patients with joint instability or inadequate ligament function, both in complex primary and revision procedures.",[20,100],"Revision Total Knee Arthroplasty","2025-03-05",{"date":103,"type":104},"2025-03-10","ACTUAL",{"date":106,"type":104},"2022-06-21",{"date":108,"type":96},"2026-07",{"name":5,"class":6},3]