[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486862":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":16,"locations":25,"responsibleParty":48,"collaborators":7,"id":50,"slug":7,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":7,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":7,"enrollmentInfo":58,"targetDuration":7,"studyType":61,"phases":7,"briefSummary":62,"conditions":63,"keywords":7,"overallStatus":27,"whyStopped":7,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Exactech","INDUSTRY",null,[9,13],{"name":10,"affiliation":11,"role":12},"Samuel Adams, MD","Duke Department of Orthopaedic Surgery","PRINCIPAL_INVESTIGATOR",{"name":14,"affiliation":15,"role":12},"Edward Haupt, MD","Mayo Clinic",[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",[26,39],{"facility":15,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":7},"RECRUITING","Jacksonville","Florida","32224","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-81.65565,30.33218,{"lat":37,"lon":36},{"facility":11,"status":27,"city":40,"state":41,"zip":42,"country":31,"countryCode":32,"cosmosGeoPoint":43,"geoPoint":47,"contacts":7},"Durham","North Carolina","27703",{"type":34,"coordinates":44},[45,46],-78.89862,35.99403,{"lat":46,"lon":45},{"type":49,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100486862",false,"NCT05619588","Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only","An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System","Inclusion Criteria:\n\n* Patient is indicated for total ankle arthroplasty\n* Patient is skeletally mature\n* Patient is mentally capable of completing follow-up forms\n* Patient will be available for follow-up out to 10 years\n* Patient has been deemed a candidate for Ankle replacement by diagnosis of the investigator\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* Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength)\n* Patient 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* Previous ankle arthrodesis with excision of the malleoli\n* Excessive loads as caused 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* Patient who is pregnant","ALL","21 Years",{"count":59,"type":60},370,"ESTIMATED","OBSERVATIONAL","The objectives of this study are to evaluate the performance and safety of the Vantage Total Ankle System. This study will follow subjects for a period of up to 10 years post-surgery.",[64,65,66],"Ankle Rheumatoid Arthritis","Arthritis of Ankle","Failure, Prosthesis","2025-02-26",{"date":69,"type":70},"2025-02-27","ACTUAL",{"date":72,"type":70},"2017-04-04",{"date":74,"type":60},"2031-09-30",{"name":5,"class":6},2]