[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492417":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":29,"armGroups":25,"interventions":25,"overallOfficials":30,"centralContacts":38,"locations":47,"responsibleParty":78,"collaborators":25,"id":80,"slug":25,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":25,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":25,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":25,"briefSummary":92,"conditions":93,"keywords":25,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Exactech","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":25},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"AOFAS","American Orthopedic Foot and Ankle Society Score (AOFAS) - Questionaire on pain (40 points), function (45 points) , and alignment (15 points) - 100 points score where 100 indicates a healthy midfoot","Through study completion, an average of 1 per year",{"measure":14,"description":15,"timeFrame":12},"SMFA","Short Musculoskeletal Function Assessment (SMFA) Score - 46 items Patient questionnaire divided into two sections: 34 questions on patients function assessment and 12 questions covering how bothered patients are by their symptoms where 1 indicates no problems\u002Fno difficulty\u002F not bothered and 5 indicates unable to do\u002Fsymptoms all the time\u002Fbeing greatly bothered",{"measure":17,"description":18,"timeFrame":12},"SF-36","Short Form Health Survey (SF-36) Score - 36-item patient-reproted survey of patient health - It consists on 8 scales: Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each scale is transformed into a 0-100 scale where the lower score indicates the more disability and the higher score the lest disability",{"measure":20,"description":21,"timeFrame":12},"Sports Frequency Score","Sports Frequency Score - Level of sport activity in leisure time where 0 indicates \"no sports activity\" and 4 indicates \"professional level of sports activity, elite athlete",{"measure":23,"description":24,"timeFrame":12},"VAS Pain score and Patient Satisfaction","Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity",null,{"allocation":25,"interventionModel":25,"interventionModelDescription":25,"primaryPurpose":25,"observationalModel":27,"timePerspective":28,"maskingInfo":25},"COHORT","OTHER","Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer",[31,35],{"name":32,"affiliation":33,"role":34},"Victor Valderrabano, MD, PhD","SWISS ORTHO CENTER Pain Clinic Basel","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Mario Herrera- Perez, MD, PhD","Hospital Universitario de Canarias",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},"Rachael Craig","CONTACT","352-377-1140","rachael.craig@exac.com",{"name":45,"role":41,"phone":42,"phoneExt":25,"email":46},"Sandrine Angibaud","sandrine.angibaud@exac.com",[48,64],{"facility":37,"status":49,"city":50,"state":25,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Santa Cruz de Tenerife","38320","Spain","ES",{"type":55,"coordinates":56},"Point",[57,58],-16.25462,28.46824,{"lat":58,"lon":57},[61],{"name":62,"role":41,"phone":63,"phoneExt":25,"email":25},"Alejandro Herrera","+ 0034 922678500",{"facility":33,"status":49,"city":65,"state":25,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Basel","CH-4010","Switzerland","CH",{"type":55,"coordinates":70},[71,72],7.57327,47.55839,{"lat":72,"lon":71},[75],{"name":76,"role":41,"phone":77,"phoneExt":25,"email":25},"Victor Valderrabano","+41 61 295 88 80",{"type":79,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":89,"type":90},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.",[94,95,96],"Rheumatoid Arthritis","Arthritis of Ankle","Failure, Prosthesis","2025-02-26",{"date":99,"type":100},"2025-02-27","ACTUAL",{"date":102,"type":100},"2019-04-08",{"date":104,"type":90},"2031-09-30",{"name":5,"class":6},2]