[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ankle-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ankle-fracture":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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":20,"type":21},1400,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Ankle Fracture","Rehabilitation","Recovery",[31,32,33,34,35,36],"ankle fracture","Brace","walker","ankle stirrup","intervention","RCT","RECRUITING","2026-04-28",{"date":40,"type":41},"2026-04-29","ACTUAL",{"date":43,"type":41},"2026-04-23",{"date":45,"type":21},"2029-09-30",{"name":47,"class":48},"Odense University Hospital","OTHER",16,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":76,"locationsCount":77},"100633054","physical-recovery-during-bracing-after-ankle-fracture-re-baf-100633054","NCT07521696","Physical Recovery During Bracing After Ankle Fracture (Re-BAF)","Physical Recovery During Bracing After Ankle Fracture (Re-BAF): A Multi-Center Superiority Analysis Nested Within a Non-inferiority Randomised Controlled Trial (BAF; NCT07163091)","Re-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* Open fractures (skin perforation)\n* Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)\n* Non-weight bearing treatment\n* Inability to adhere to trial procedures (e.g. neuropathy or severe psychiatric disorder)\n* Allergy to SENS Motion adhesive patches\n* Inability to read or speak Danish\n* Uninterest in participating",{"count":59,"type":21},280,[24],"Ankle fractures are among the most common fractures and represent the second most frequent fracture type requiring surgery. Many patients experience long-term pain, stiffness, and reduced ankle function, which substantially limits their physical activity. Even five years after injury, more than a third of patients have not regained their pre-injury activity levels.\n\nStandard treatment typically involves immobilisation using a rigid foot-ankle brace (walker). Although effective in protecting fracture healing, these braces may be overly restrictive, contributing to ankle stiffness, swelling, delayed physical recovery and return to daily activities, and reduced quality of life. Patients increasingly express a preference for lighter, movement-permitting ankle supports, such as minimal ankle stirrups. Recent evidence suggests that braces and elastic bands that allow more ankle movement than walkers may enhance faster recovery without increasing complications.\n\nHowever, high quality evidence is necessary for more robust conclusions. The Scandinavian Bracing after Ankle Fracture (BAF) multicentre randomised controlled trial (NCT07163091) therefore investigates whether an ankle stirrup is non-inferior to a standard walker with respect to patient-reported ankle pain and function, measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The primary hypothesis is that ankle stirrups better align with patients' preferences for less restrictive bracing while providing sufficient stability during fracture healing. Secondarily, ankle stirrups may promote faster recovery and physical activity.\n\nThe Re-BAF trial is nested within a larger multicentre non-inferiority trial (Bracing after Ankle Fracture \\[BAF\\], ClinicalTrials.gov ID: NCT07163091), aiming to investigate whether an ankle stirrup is non-inferior to a standard foot-ankle brace in improving patient-reported foot and ankle function, as measured by the Manchester-Oxford Foot Questionnaire (\\[MOXFQ\\], primary BAF outcome) after ankle fracture.\n\nThe aim of the Re-BAF trial is to investigate whether ankle stirrups are superior to standard foot-ankle braces in improving physical activity, assessed using objectively measured thigh-worn accelerometry from baseline (i.e. randomisation) to 12-week follow-up. We hypothesize that early and continuous movement during rehabilitation, enabled by an ankle stirrup, is superior in improving physical activity compared with a foot-ankle brace, without compromising fracture healing.",[27,29,63,28],"Physical Activity",[65,29,28,66,67,68],"Ankle Fractures","Braces","Physical activity","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-04-07",{"date":72,"type":41},"2026-04-13",{"date":74,"type":21},"2026-04-01",{"date":45,"type":21},{"name":47,"class":48},1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":77},"100575466","phase-4-compression-therapy-for-swelling-management-following-ankle-injury-100575466","NCT06772649","Compression Therapy for Swelling Management Following Ankle Injury","Investigating the Safety and Efficacy of Compression Therapy for Controlling Swelling in Post-Injury Ankle Management","Inclusion Criteria:\n\n* Patients undergoing outpatient ankle, mid-foot or hindfoot arthrodesis, fracture surgery, or non-operative ankle fracture management at the Queen Elizabeth II Health Sciences Center.\n* Aged 18 or over\n\nExclusion Criteria:\n\n* Patients undergoing other ankle procedures\n* Patients who have any signs of wound healing complications post-surgery\n* Patients who are unable to progress to walking boot and weight-bearing management at 6 weeks post operation\u002Finjury.\n* Patients with other co-morbidities that may create bias within the results (lymphedema, heart conditions etc.)\n* Patients who are unable to speak and read English, and\u002For in the opinion of the Principal Investigator are unable to provide fully informed consent.",{"count":86,"type":21},50,[88],"PHASE4","After an injury or undergoing foot\u002Fankle surgery, patients often experience swelling in the injured area. Under current standard of care, plaster casts are removed at six weeks and patients are put in a walking boot. At this point in time of their recovery, patients are permitted to weight bear and move in their walking boot without other help, like crutches. This has shown to cause a significant amount of swelling in the ankle and foot between week six and twenty-six post-injury\u002Fsurgery.\n\nThere is not much research that has looked at the effects of compression on reducing swelling in post-operative and non-operative ankle fracture, mid-foot, hindfoot, or ankle arthrodesis. This research is important because post-injury swelling can lead to wound complications and limit functionality. Therefore, finding new ways to reduce swelling could help prevent future complications.\n\nThe purpose of this study is to see if the Bauerfeind ankle compression sleeve is a safe post-operative\u002Finjury foot and ankle swelling management tool. Use of a compression sleeve will be compared to just using a walking boot, which is current standard of care, to determine if the compression sleeve reduces post-operative\u002Finjury foot and ankle swelling.\n\nThe study will follow patients improvement in swelling and pain. The compression sleeve will also be assessed for product safety. Safety is determined by watching the frequency, severity and seriousness of any side effects or complications, known as adverse events, that may be experienced while in the study.\n\nThe Bauerfeind ankle compression sleeve has been and is currently used in humans as a swelling reducing devise in the foot and ankle but has not been studied in a randomized control trial.",[27,91],"Ankle Arthrodesis",[93,94,95,96,97],"non-operative ankle fracture management","operative ankle fracture management","ankle arthrodesis","mid-foot arthrodesis","hind-foot arthrodesis","2025-01-22",{"date":100,"type":41},"2025-01-24",{"date":102,"type":21},"2025-04-01",{"date":104,"type":21},"2026-05-30",{"name":106,"class":48},"Nova Scotia Health Authority"]