[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492417":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":16,"locations":25,"responsibleParty":56,"collaborators":7,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":7,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":7,"enrollmentInfo":67,"targetDuration":7,"studyType":70,"phases":7,"briefSummary":71,"conditions":72,"keywords":7,"overallStatus":27,"whyStopped":7,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Exactech","INDUSTRY",null,[9,13],{"name":10,"affiliation":11,"role":12},"Victor Valderrabano, MD, PhD","SWISS ORTHO CENTER Pain Clinic Basel","PRINCIPAL_INVESTIGATOR",{"name":14,"affiliation":15,"role":12},"Mario Herrera- Perez, MD, PhD","Hospital Universitario de Canarias",[17,22],{"name":18,"role":19,"phone":20,"phoneExt":7,"email":21},"Rachael Craig","CONTACT","352-377-1140","rachael.craig@exac.com",{"name":23,"role":19,"phone":20,"phoneExt":7,"email":24},"Sandrine Angibaud","sandrine.angibaud@exac.com",[26,42],{"facility":15,"status":27,"city":28,"state":7,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"RECRUITING","Santa Cruz de Tenerife","38320","Spain","ES",{"type":33,"coordinates":34},"Point",[35,36],-16.25462,28.46824,{"lat":36,"lon":35},[39],{"name":40,"role":19,"phone":41,"phoneExt":7,"email":7},"Alejandro Herrera","+ 0034 922678500",{"facility":11,"status":27,"city":43,"state":7,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Basel","CH-4010","Switzerland","CH",{"type":33,"coordinates":48},[49,50],7.57327,47.55839,{"lat":50,"lon":49},[53],{"name":54,"role":19,"phone":55,"phoneExt":7,"email":7},"Victor Valderrabano","+41 61 295 88 80",{"type":57,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100492417","vantage-mobile-bearing-total-ankle-system-post-market-clinical-follow-up-outside-us-100492417",false,"NCT05691868","Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)","An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)","Inclusion Criteria:\n\n* Patient is indicated for total ankle arthroplasty\n* Patient is at least 21 years of age\n* Patient is likely to be available for follow-up out to 10 years\n* Patient is willing to participate by complying with pre- and postoperative visit requirements\n* Patient is willing and able to read and sign a study informed consent form\n\nExclusion Criteria:\n\n* Patient with excessive bone loss at the ankle joint site\n* Patient with severe osteoporosis\n* Patient with complete talar avascular necrosis\n* Patient with active osteomyelitis\n* Patient with infection at the ankle site or infection at distant sites that could migrate to the ankle\n* Patient with sepsis\n* Patient with vascular deficiency in the involved limb\n* Pateint with neuropathic joints\n* Patient with neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing\n* Patient with poor soft tissue coverage around the ankle\n* Patient with Charcot arthropathy\n* Previsous ankle arthrodesis with excision of the malleoli\n* Excessive loads as cuased by activity or patient weight - per investigator discretion\n* Skeletally immature patients (patient is less than 21 years if age at time of surgery)\n* Patient with dementia\n* Patient with known metal allergies\n* Patients who are unwilling to provide informed consent\n* Patients who are unlikely to be available for follow-up out to 10 years\n* Patients who are not deemed suitable candidates for the subject device\n* Patient is pregnant","ALL","21 Years",{"count":68,"type":69},400,"ESTIMATED","OBSERVATIONAL","The objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.",[73,74,75],"Rheumatoid Arthritis","Arthritis of Ankle","Failure, Prosthesis","2025-02-26",{"date":78,"type":79},"2025-02-27","ACTUAL",{"date":81,"type":79},"2019-04-08",{"date":83,"type":69},"2031-09-30",{"name":5,"class":6},2]