[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605482":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":263,"collaborators":265,"id":294,"slug":295,"hasResults":296,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":296,"sex":302,"minAge":303,"maxAge":25,"enrollmentInfo":304,"targetDuration":25,"studyType":307,"phases":308,"briefSummary":310,"conditions":311,"keywords":315,"overallStatus":77,"whyStopped":25,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"foot ankel brace (walker)","ACTIVE_COMPARATOR","Walker: immobilisation during use",[13],"Other: Foot-ankel brace (walker)",{"label":15,"type":16,"description":17,"interventionNames":18},"Ankel stirrup","EXPERIMENTAL","Ankel stirrup: active ankel dorsal and plantar flextion during use",[19],"Other: ankel stirrup",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"ankel stirrup","Ankel stirrups are a patient preferred ankel brace that allow active ankle dorsal and plantar flexion during weightbearing while maintaining lateral stability.",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Foot-ankel brace (walker)","Walkers immobilise and stabilise the ankle during weightbearing.",[9],[31],{"name":32,"affiliation":33,"role":34},"Bjarke Viberg, Phd","Odense Universitetshospital Ortopaedkirurgisk Afdeling","STUDY_CHAIR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Jonas A Ipsen, phd","CONTACT","+4523925264","Jonas.Ammundsen.Ipsen@rsyd.dk",{"name":32,"role":38,"phone":25,"phoneExt":25,"email":42},"bjarke.viberg@rsyd.dk",[44,62,75,89,102,115,128,141,154,170,183,197,210,223,236,249],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Orthopedic Department, Hospital of Southern Jutland","NOT_YET_RECRUITING","Aabenraa","6200","Denmark","DK",{"type":52,"coordinates":53},"Point",[54,55],9.41741,55.04434,{"lat":55,"lon":54},[58,59],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},"Nikolaj H Schmidt, MD phd","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":46,"city":64,"state":25,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Orthopedic Department, Aalborg Universitets Hospital","Aalborg","9000",{"type":52,"coordinates":67},[68,69],9.9187,57.048,{"lat":69,"lon":68},[72,73],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":74,"role":61,"phone":25,"phoneExt":25,"email":25},"Rasmus A Elsøe, MD phd",{"facility":76,"status":77,"city":78,"state":25,"zip":79,"country":49,"countryCode":50,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Orthopedic Department, Aarhus University Hospital","RECRUITING","Aarhus","8200",{"type":52,"coordinates":81},[82,83],10.21076,56.15674,{"lat":83,"lon":82},[86,87],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":88,"role":61,"phone":25,"phoneExt":25,"email":25},"Jeppe Lange, MD phd",{"facility":90,"status":46,"city":91,"state":25,"zip":92,"country":49,"countryCode":50,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Orthopedic Department, Bispebjerg Hospital","Copenhagen","2200",{"type":52,"coordinates":94},[95,96],12.56553,55.67594,{"lat":96,"lon":95},[99,100],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":101,"role":61,"phone":25,"phoneExt":25,"email":25},"Arving G Von Keudell, MD phd",{"facility":103,"status":46,"city":104,"state":25,"zip":105,"country":49,"countryCode":50,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Orthopedic Department, Hospital of South West Jutland","Esbjerg","6700",{"type":52,"coordinates":107},[108,109],8.45187,55.47028,{"lat":109,"lon":108},[112,113],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":114,"role":61,"phone":25,"phoneExt":25,"email":25},"Lars L Hermansen, MD phd",{"facility":116,"status":46,"city":117,"state":25,"zip":118,"country":49,"countryCode":50,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Orthopedic Department, Herlev Hospital","Herlev","2730",{"type":52,"coordinates":120},[121,122],12.43998,55.72366,{"lat":122,"lon":121},[125,126],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":127,"role":61,"phone":25,"phoneExt":25,"email":25},"Peter Max Halschou-Jensen, MD phd",{"facility":129,"status":46,"city":130,"state":25,"zip":131,"country":49,"countryCode":50,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Orthopedic Department, North Zealand Hospital","Hillerød","3400",{"type":52,"coordinates":133},[134,135],12.30081,55.92791,{"lat":135,"lon":134},[138,139],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":140,"role":61,"phone":25,"phoneExt":25,"email":25},"Jonas A Andersen, MD phd",{"facility":142,"status":46,"city":143,"state":25,"zip":144,"country":49,"countryCode":50,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Orthopedic Department, Hvidovre Hospital","Hvidovre","2650",{"type":52,"coordinates":146},[147,148],12.47708,55.64297,{"lat":148,"lon":147},[151,152],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":153,"role":61,"phone":25,"phoneExt":25,"email":25},"Tazio Maleitzke, MD phd",{"facility":155,"status":77,"city":156,"state":25,"zip":157,"country":49,"countryCode":50,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Orthopedic Department, Hospital Lillebaelt - Kolding","Kolding","6000",{"type":52,"coordinates":159},[160,161],9.47216,55.4904,{"lat":161,"lon":160},[164,165,167],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":166,"role":61,"phone":25,"phoneExt":25,"email":25},"Lars Rottwitt, MD phd",{"name":168,"role":169,"phone":25,"phoneExt":25,"email":25},"Ane Simony, MD phd","SUB_INVESTIGATOR",{"facility":171,"status":77,"city":172,"state":25,"zip":173,"country":49,"countryCode":50,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Orthopedic Department, Zealand University Hospital - Køge","Køge","4600",{"type":52,"coordinates":175},[176,177],12.18214,55.45802,{"lat":177,"lon":176},[180,181],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":182,"role":61,"phone":25,"phoneExt":25,"email":25},"Rasmus H Juul, MD phd",{"facility":184,"status":77,"city":185,"state":25,"zip":186,"country":49,"countryCode":50,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Orthopedic Department, Odense University Hospital","Odense","5000",{"type":52,"coordinates":188},[189,190],10.38831,55.39594,{"lat":190,"lon":189},[193,195],{"name":194,"role":38,"phone":39,"phoneExt":25,"email":40},"Jonas A Ipsen, Phd",{"name":196,"role":61,"phone":25,"phoneExt":25,"email":25},"Jonas A Ipsen A, phd",{"facility":198,"status":46,"city":199,"state":25,"zip":200,"country":49,"countryCode":50,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Orthopedic Department, Randers Hospital","Randers","5930",{"type":52,"coordinates":202},[203,204],10.03639,56.4607,{"lat":204,"lon":203},[207,208],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":209,"role":61,"phone":25,"phoneExt":25,"email":25},"Daniel Wæver, MD phd",{"facility":211,"status":46,"city":212,"state":25,"zip":213,"country":49,"countryCode":50,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Orthopedic Department, Slagelse Hospital","Slagelse","4200",{"type":52,"coordinates":215},[216,217],11.35459,55.40276,{"lat":217,"lon":216},[220,221],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":222,"role":61,"phone":25,"phoneExt":25,"email":25},"Chris H Dreyer, MD phd",{"facility":224,"status":46,"city":225,"state":25,"zip":226,"country":49,"countryCode":50,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Orthopedic Department, Hospital Lillebaelt - Vejle","Vejle","7100",{"type":52,"coordinates":228},[229,230],9.5357,55.70927,{"lat":230,"lon":229},[233,234],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":235,"role":61,"phone":25,"phoneExt":25,"email":25},"Claus T Varnum, MD phd",{"facility":237,"status":46,"city":238,"state":25,"zip":239,"country":49,"countryCode":50,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Orthopedic Department, Viborg Hospital","Viborg","8800",{"type":52,"coordinates":241},[242,243],9.40201,56.45319,{"lat":243,"lon":242},[246,247],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":248,"role":61,"phone":25,"phoneExt":25,"email":25},"Marianne T Vestermark, MD phd",{"facility":250,"status":46,"city":251,"state":25,"zip":25,"country":252,"countryCode":253,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Surgical Centre, National Hospital of the Faroe Islands","Tórshavn","Faroe Islands","FO",{"type":52,"coordinates":255},[256,257],-6.77164,62.00973,{"lat":257,"lon":256},[260,261],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":262,"role":61,"phone":25,"phoneExt":25,"email":25},"Pætur m Holm, phd",{"type":264,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[266,268,270,272,274,277,279,281,283,285,288,290,292],{"name":267,"class":6},"Aalborg University Hospital",{"name":269,"class":6},"Randers Regional Hospital",{"name":271,"class":6},"Aarhus University Hospital",{"name":273,"class":6},"Viborg Regional Hospital",{"name":275,"class":276},"Hospital of Southern Jutland, Aabenraa, Denmark","UNKNOWN",{"name":278,"class":6},"Slagelse Hospital",{"name":280,"class":6},"Bispebjerg Hospital",{"name":282,"class":6},"Hvidovre University Hospital",{"name":284,"class":6},"Herlev Hospital",{"name":286,"class":287},"National Hospital of the Faroe Islands","OTHER_GOV",{"name":289,"class":276},"Hospital of South West Jutland, Esbjerg, Denmark",{"name":291,"class":276},"Køge Hospital, Denmark",{"name":293,"class":6},"Sygehus Lillebaelt","100605482","bracing-after-ankle-fracture-100605482",false,"NCT07163091","Bracing After Ankle Fracture","Bracing After Ankle Fracture (BAF): a Randomised Multicenter Non-inferiority Trial Comparing Ankle Stirrups to Walkers on Pain, Function and Social Interaction for Adults After Ankle Fracture - Study Protocol","BAF","Inclusion Criteria:\n\n* 18 years or older\n* Surgically or non-surgically treated ankle fracture\n\nExclusion Criteria:\n\n* Pathological fractures\n* Inadequacy to read or speak danish\n* Open fractures\n* Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)\n* Inability to adhere to trial procedures (e.g. neuropathy or severe psychiatric disorder)\n* Restricted weightbearing\n* Uninterest in participating","ALL","18 Years",{"count":305,"type":306},1400,"ESTIMATED","INTERVENTIONAL",[309],"NA","Ankle fractures are common, debilitating and usually treated with immobilisation using a foot-ankle brace (walker). Emerging evidence suggests that a less restrictive brace may reduce recovery time without increasing the risk of complications, and patients tend to prefer ankle stirrups. However, evidence supporting their non-inferiority remains limited and inconclusive. Thus, the aim is assess if an ankle stirrup is non-inferior to a standard walker in reducing pain and function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The hypothesis is that ankel stirrups align better with patients preferenes for less immobilising braces and offer sufficient stability while the fracture heals. Secondarily it may lead to faster recovery of function, return to work and reduced cost. The sample size of a maximum of 1400 patients allow us to assess non-inferiority in age and sex specific subgroups and treatment (surgical or non-sugical). Non-inferiority will be assessed in a pragmatic, multicenter, randomised controlled trial involving Scandinavian orthopedic departments.",[312,313,314],"Ankle Fracture","Rehabilitation","Recovery",[316,317,318,319,320,321],"ankle fracture","Brace","walker","ankle stirrup","intervention","RCT","2026-04-28",{"date":324,"type":325},"2026-04-29","ACTUAL",{"date":327,"type":325},"2026-04-23",{"date":329,"type":306},"2029-09-30",{"name":5,"class":6},16]