[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517933":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":30,"studyPopulation":16,"armGroups":31,"interventions":44,"overallOfficials":16,"centralContacts":51,"locations":57,"responsibleParty":75,"collaborators":16,"id":79,"slug":16,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":16,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":16,"enrollmentInfo":88,"targetDuration":16,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":103,"whyStopped":16,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Cantonal Hospital of St. Gallen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Manchester Oxford Foot and Ankle Questionnaire","Patient reported Outcome measure","1 year",[14,17,19],{"measure":15,"description":16,"timeFrame":12},"other PROMs (patient reported outcome measures)",null,{"measure":18,"description":16,"timeFrame":12},"Range of Motion",{"measure":20,"description":16,"timeFrame":21},"Secondary dislocation of fracture","6 weeks",{"allocation":23,"interventionModel":24,"interventionModelDescription":16,"primaryPurpose":25,"observationalModel":16,"timePerspective":16,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":16,"whoMasked":28},"SINGLE",[29],"INVESTIGATOR","This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Full weight bearing","EXPERIMENTAL","After 2 weeks after surgery the arm will begin full weight bearing",[37],"Other: Full weight bearing",{"label":39,"type":40,"description":41,"interventionNames":42},"Partial weight bearing","ACTIVE_COMPARATOR","The arm will perform partial weight bearing for 6 weeks after surgery",[43],"Other: Partial weight bearing",[45,48],{"type":6,"name":33,"description":46,"armGroupLabels":47,"otherNames":16},"Full weight bearing monitored with a bio-feedback insole",[33],{"type":6,"name":39,"description":49,"armGroupLabels":50,"otherNames":16},"Partial weight bearing monitored with a bio-feedback insole",[39],[52],{"name":53,"role":54,"phone":55,"phoneExt":16,"email":56},"Primoz Potocnik, MD","CONTACT","0041714941111","primoz.potocnik@kssg.ch",[58],{"facility":59,"status":16,"city":60,"state":16,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Canton Hospital St. Gallen","Sankt Gallen","9007","Switzerland","CH",{"type":65,"coordinates":66},"Point",[67,68],9.37477,47.42391,{"lat":68,"lon":67},[71,72],{"name":53,"role":54,"phone":16,"phoneExt":16,"email":56},{"name":73,"role":54,"phone":16,"phoneExt":16,"email":74},"Andreas Toepfer, MD","andreas.toepfer@kssg.ch",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Primoz Potocnik","Dr. med. Primoz Potocnik","100517933",false,"NCT06023979","Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.","Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles. A Single Blinded Randomized Controlled Study","Inclusion Criteria:\n\n* patients with surgically stabilized unstable ankle fractures\n* signed informed consent\n* closed tibial and fibular epiphysis\n* age 18 or older\n\nExclusion Criteria:\n\n* dementia and other known cognitive impairment or incapacity of judgement\n* polytrauma\n* bilateral injury of the lower extremities\n* additional injury of the ipsilateral lower extremity which prevents full weight bearing\n* associated injury of one or both upper extremities\n* open fractures grade II° and III°\n* chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy\n* open epiphysis\n* pregnancy",true,"ALL","18 Years",{"count":89,"type":90},110,"ESTIMATED","INTERVENTIONAL",[93],"NA","The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.",[96],"Post Operative Treatment After Unstable Malleolar Fractures",[98,99,100,101,102],"malleolar fractures","postoperative treatment protocol","full weight bearing","partial weight bearing","bio-feedback insoles","NOT_YET_RECRUITING","2023-08-29",{"date":106,"type":107},"2023-09-05","ACTUAL",{"date":109,"type":90},"2023-09-01",{"date":111,"type":90},"2026-10-31",{"name":5,"class":6},1]