[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100395447":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":62,"collaborators":25,"id":64,"slug":25,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Ente Ospedaliero Cantonale, Bellinzona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm-A","EXPERIMENTAL","experimental post-operative rehabilitation intervention consisting in immediate weight-bearing",[13],"Other: immediate post-operative complete weight-bearing after surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm-B","ACTIVE_COMPARATOR","control post-operative rehabilitation intervention consisting in delayed weight-bearing",[19],"Other: delayed weight-bearing for 6 weeks after surgery",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"immediate post-operative complete weight-bearing after surgery","Patients randomized to the experimental post-operative rehabilitation intervention will undergo to immediate complete weight-bearing starting immediately after surgery. Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids.\n\nDuring the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED); this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"delayed weight-bearing for 6 weeks after surgery","Patients randomized to the control post-operative rehabilitation intervention will undergo to delayed weight-bearing starting at 6-weeks post-operatively. Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery.\n\nDuring the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED).",[15],[31],{"name":32,"affiliation":33,"role":34},"Enrique Adrian Testa, MD","EOC","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+41 (0)91 811 69 31","enriqueadrian.testa@eoc.ch",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Christian Candrian, MD, Prof","+41 091 811 61 23","Christian.candrian@eoc.ch",[45],{"facility":46,"status":47,"city":48,"state":25,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Ente Ospedaliero Cantonale","RECRUITING","Lugano","6900","Switzerland",{"type":52,"coordinates":53},"Point",[54,55],8.96004,46.01008,{"lat":55,"lon":54},[58,59],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":41,"role":37,"phone":60,"phoneExt":25,"email":61},"+41 (0) 91 811 61 23","christian.candrian@eoc.ch",{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100395447",false,"NCT04429217","A Study to Compare Two Different Managements After Ankle Surgery: Immediate and Delayed Weight-bearing.","Immediate vs Delayed Weight-bearing After Surgical Treatment of Malleolar Fractures: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Male and female adults\n* Age ranging from 18 to 70 years, included\n* Signed Informed Consent\n* Ankle fracture requiring surgical management classified as:1- Weber A fracture pattern (AO 44.A1, 44.A2, 44.A3) with or without association with a medial or posterior lesion\u002Ffracture or 2- Weber B fracture pattern (AO 44.B1, 44.B2, 44.B3) with or without association with a medial or posterior lesion\u002Ffracture\n* Willingness and ability to participate in the trial\n\nExclusion Criteria:\n\n* Weber C fracture pattern\n* Bilateral fractures or fractures in other locations\n* Maissoneauve associated lesion\n* Body Mass Index \\\u003C 18.5 and ≥ 30\n* Metabolic diseases influencing fracture healing processes\n* Medical comorbidities precluding operative intervention\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.\n* Inability or contraindications to undergo the investigated intervention\n* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)\n* Pregnant women","ALL","18 Years","70 Years",{"count":74,"type":75},100,"ESTIMATED","INTERVENTIONAL",[78],"NA","The investigators will compare two types of rehabilitation in patients who undergo a surgery for treatment of malleolar fractures: immediate complete weight-bearing and delayed weight-bearing.\n\nThe investigators want to evaluate if the immediate complete weight-bearing can improve and hasten the functional outcome of the ankle without increasing the risk of complications.",[81],"Lateral Malleolus Fracture",[83,84,85],"Ankle","surgical treatment","malleolar fractures","2025-08-06",{"date":88,"type":89},"2025-08-07","ACTUAL",{"date":91,"type":89},"2020-04-28",{"date":93,"type":75},"2028-02-02",{"name":5,"class":6},1]