[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486862":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":29,"armGroups":25,"interventions":25,"overallOfficials":30,"centralContacts":38,"locations":47,"responsibleParty":70,"collaborators":25,"id":72,"slug":25,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":25,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":25,"briefSummary":84,"conditions":85,"keywords":25,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"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 and Patient Satisfaction Score","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},"Samuel Adams, MD","Duke Department of Orthopaedic Surgery","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Edward Haupt, MD","Mayo Clinic",[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",[48,61],{"facility":37,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":25},"RECRUITING","Jacksonville","Florida","32224","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-81.65565,30.33218,{"lat":59,"lon":58},{"facility":33,"status":49,"city":62,"state":63,"zip":64,"country":53,"countryCode":54,"cosmosGeoPoint":65,"geoPoint":69,"contacts":25},"Durham","North Carolina","27703",{"type":56,"coordinates":66},[67,68],-78.89862,35.99403,{"lat":68,"lon":67},{"type":71,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"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":81,"type":82},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.",[86,87,88],"Ankle Rheumatoid Arthritis","Arthritis of Ankle","Failure, Prosthesis","2025-02-26",{"date":91,"type":92},"2025-02-27","ACTUAL",{"date":94,"type":92},"2017-04-04",{"date":96,"type":82},"2031-09-30",{"name":5,"class":6},2]