[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arthritis-of-ankle\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arthritis-of-ankle":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"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":19,"type":20},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.",[24,25,26],"Rheumatoid Arthritis","Arthritis of Ankle","Failure, Prosthesis","RECRUITING","2025-02-26",{"date":30,"type":31},"2025-02-27","ACTUAL",{"date":33,"type":31},"2019-04-08",{"date":35,"type":20},"2031-09-30",{"name":37,"class":38},"Exactech","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":51,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":55,"locationsCount":5},"100486862","exactech-vantage-total-ankle-system-post-market-clinical-follow-up---us-only-100486862","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",{"count":47,"type":20},370,"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.",[50,25,26],"Ankle Rheumatoid Arthritis",{"date":30,"type":31},{"date":53,"type":31},"2017-04-04",{"date":35,"type":20},{"name":37,"class":38}]