[{"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,4,0,[8,48,80,106],{"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":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100650778","early-virtual-ankle-rehabilitation-evar-acceptability-100650778",false,"NCT07751107","Early Virtual Ankle Rehabilitation (EVAR): Acceptability","Early Virtual Ankle Rehabilitation (EVAR): A Proof-of-concept Feasibility Study Exploring Patient Acceptability Using Qualitative Interviews With Nested Quantitative Analysis.","EVAR-Accept","Eligibility Criteria:\n\nAdults who have undergone ankle fracture surgery\n\nInclusion Criteria:\n\n* Adults of either sex, aged 18 years and older, with no upper limit.\n* Within the last 21 days, they underwent open reduction and internal fixation (ORIF) for an ankle fracture; AO44, AO43B and AO43C classifications and subclassifications.\n* Any orthopaedic weightbearing instructions, ranging from non-weightbearing to unrestricted weightbearing.\n\nExclusion Criteria:\n\n* Unable or unwilling to give informed written consent for any reason.\n* Unable or unwilling to engage with the early ankle rehabilitation programme.\n* Severe open fractures (Gustilo Anderson G3)\n* A clinical decision was made that the ankle should remain cast immobilised until the subsequent orthopaedic review, which is beyond 21 days post-surgery.\n* If, in the opinion of the clinical and research staff, it is in the patient's best interest to be excluded due to presentations such as, but not limited to:\n\n  * Soft tissue concerns where early movement may risk tissue breakdown.\n  * Comorbidities associated with slowed tissue healing, such as non-healing leg\u002Ffoot ulcers, medicating diabetics and a lack of protective distal sensation (e.g. peripheral neuropathy).\n  * There is a plausible concern that the individual has been or will be non-compliant with the most recent treatment advice, for example, weightbearing contrary to orthopaedic advice.\n* Inability to adhere to study procedures, including, but not limited to, the following:\n\n  * Lacking the capacity to adhere to the study intervention (minor assistance from family and friends is permissible).\n  * Unable to converse fluently in English for the interviews or lack the capacity or ability to complete the study questionnaire in English.\n  * Does not have access to and\u002For rudimentary capacity to use virtual clinic technology (assistance from family and friends is permissible).\n* Currently taking part or having taken part in a research study in the last 3 months that involves\u002Finvolved invasive procedures. Where the circumstances of a potential participant are ambiguous, clarification with the CI or PI should be sought.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this study is to learn about people's experiences of how physiotherapy is received having recently had surgery for a broken ankle. The ways to receive the rehabilitation will be via video, call Early Virtual Ankle Rehabilitation (EVAR), and face-to-face at the hospital. The content of the rehabilitation programme will be the same for both groups.\n\nThe main questions that the study aims to answer are:\n\n* During the early weeks of recovery after ankle surgery, how happy are people to have physiotherapy support by video call (EVAR) compared with face-to-face appointments at the hospital?\n* Is it practical to run a larger study on how well EVAR helps recovery from ankle fracture surgery?\n\nParticipants will be put into one of two groups by chance:\n\n* A group that has EVAR, with physiotherapy appointments by video call to their home.\n* A group that has face-to-face physiotherapy appointments at the hospital.\n\nAll participants will receive the same early physiotherapy programme. The only difference between the groups is how physiotherapy support is received.\n\nParticipants in both groups will:\n\n* Start the physiotherapy programme at about 2-weeks after surgery.\n* Receive advice and information about recovery.\n* Carry out ankle exercises at home, while sitting or lying.\n* Have at least two physiotherapy appointments between 2 and 6 weeks after surgery.\n* At week-6, take part in an interview to explore the experiences of the physiotherapy programme and method of interacting with the physiotherapist.\n* Complete questionnaires about their recovery and their experiences, with a final set at about 12 weeks after surgery.\n\nBetween 21 to 30 adults who have had surgery for a broken ankle will take part in this study. About twice as many participants will have physiotherapy appointments by video call as those who have appointments at the hospital.\n\nThe information from this study will help researchers understand whether physiotherapy support by video call are a good fit for people recovering from ankle surgery. It will also help decide whether a larger study should be carried out in the future.",[27],"Ankle Fracture",[29,30,31,32,33,34],"Physical therapy","Physiotherapy","Exercise","Rehabilitation","Virtual","Remote","NOT_YET_RECRUITING","2026-08-03",{"date":38,"type":39},"2026-08-07","ACTUAL",{"date":41,"type":21},"2026-07-22",{"date":43,"type":21},"2027-09-30",{"name":45,"class":46},"University of Nottingham","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100605482","bracing-after-ankle-fracture-100605482","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",{"count":57,"type":21},1400,[24],"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.",[27,32,61],"Recovery",[63,64,65,66,67,68],"ankle fracture","Brace","walker","ankle stirrup","intervention","RCT","RECRUITING","2026-04-28",{"date":72,"type":39},"2026-04-29",{"date":74,"type":39},"2026-04-23",{"date":76,"type":21},"2029-09-30",{"name":78,"class":46},"Odense University Hospital",16,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":105,"locationsCount":47},"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":89,"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.",[27,61,93,32],"Physical Activity",[95,61,32,96,97,98],"Ankle Fractures","Braces","Physical activity","Randomized Controlled Trial","2026-04-07",{"date":101,"type":39},"2026-04-13",{"date":103,"type":21},"2026-04-01",{"date":76,"type":21},{"name":78,"class":46},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":47},"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":114,"type":21},50,[116],"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.",[27,119],"Ankle Arthrodesis",[121,122,123,124,125],"non-operative ankle fracture management","operative ankle fracture management","ankle arthrodesis","mid-foot arthrodesis","hind-foot arthrodesis","2025-01-22",{"date":128,"type":39},"2025-01-24",{"date":130,"type":21},"2025-04-01",{"date":132,"type":21},"2026-05-30",{"name":134,"class":46},"Nova Scotia Health Authority"]