[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533032":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":24,"responsibleParty":54,"collaborators":58,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":18,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":18,"overallStatus":89,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Casting and Supervised Rehabilitation","EXPERIMENTAL","Patients in the intervention group will undergo non-weightbearing immobilization for 8 weeks in phase one: 4 in a circular cast with non-weightbearing followed by 4 weeks toe-tip weightbearing (10-20% of body weight) in a walking boot during daytime and a removable cast at night. In phase 2, a supervised rehabilitation will be performed till week 16 after which phase 3 will start at week 16-18",[13],"Other: Casting and supervised rehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","NO_INTERVENTION","Patients in the control group will undergo the standard care. Standard care (''skill-full'' neglect) is described as adjustment of activities within the boundaries of pain. They can perform all activities wanted, except for painful activities. Patients and caretakers will be advised on the amount of activities by specialized orthopedic surgeons and periodical evaluation, and adjustment, will take place at the regular follow-up moments which is the same as in the intervention group. In this group, no supervised training or rehabilitation will be performed.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Casting and supervised rehabilitation","casting (8 weeks) followed by supervised rehabilitation",[9],[25,43],{"facility":26,"status":18,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Amphia Hospital Breda","Breda","Molengracht 21","4818CK","Netherlands","NL",{"type":33,"coordinates":34},"Point",[35,36],4.77596,51.58656,{"lat":36,"lon":35},[39],{"name":40,"role":41,"phone":18,"phoneExt":18,"email":42},"Tristan Buck, MSc","CONTACT","t.m.buck@amsterdamumc.nl",{"facility":44,"status":18,"city":45,"state":18,"zip":46,"country":30,"countryCode":31,"cosmosGeoPoint":47,"geoPoint":51,"contacts":52},"Amsterdam UMC","Amsterdam","1071 TS",{"type":33,"coordinates":48},[49,50],4.88969,52.37403,{"lat":50,"lon":49},[53],{"name":40,"role":41,"phone":18,"phoneExt":18,"email":42},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Tristan Buck","PhD candidate, MD, MSc",[59,62],{"name":60,"class":61},"Emma Childrens Hospital Foundation","UNKNOWN",{"name":63,"class":61},"European Paediatric Orthopaedic Society (EPOS)","100533032","casting-and-rehabilitation-versus-supervised-neglect-for-osteochondral-lesions-of-the-talus-in-the-pediatric-population-100533032",false,"NCT06220539","CAsting and REhabilitation Versus Supervised Neglect for Osteochondral Lesions of the Talus in the Pediatric Population","CAsting and REhabilitation Versus Supervised Neglect for Osteochondral Lesions of the Talus in the Pediatric Population: The CARE Study, A Multicenter, Stratified, Block-Randomized Controlled Trial","CARE","Inclusion Criteria:\n\n* Symptomatic, osteochondral lesion of the talus\n* Diagnosed on Computed Tomography (CT)\n* Open physes of the distal tibia confirmed by a specialized musculoskeletal or pediatric radiologist\n* Age ≥4 and ≤18\n\nExclusion Criteria:\n\n* acute traumatic lesions\n* surgically treated OLTs\n* systemic diseases that can influence cartilage conditions (such as hemophilia)",true,"ALL","4 Years","18 Years",{"count":77,"type":78},76,"ESTIMATED","INTERVENTIONAL",[81],"NA","Rationale: OCLs (osteochondral lesions) of the talus can be congenital or can occur after trauma or in patients with juvenile idiopathic arthritis (JIA). The main complaint of an OCL is pain during weightbearing activities. Therefore, these lesions have significant impact on the health status of patients.\n\nObjective: The aim of this study is to optimize the treatment for skeletally immature patients with an osteochondral lesion. The hypothesis is that a period of immobilization and supervised rehabilitation will lead to better clinical and radiological outcomes compared with standard care which is a ''skill-full'' neglect.\n\nStudy design: Observational comparative study\n\nStudy population: Skeletally immature children with an osteochondral lesion of the talus diagnosed on CT.\n\nIntervention: Patients in the intervention group will undergo an 8-week period of casting and walking on crutches. Afterwards, they will receive a protocolled period of rehabilitation under supervision of a physical therapist. The control group will have the standard care as treatment.\n\nMain study parameters\u002Fendpoints: the main study outcome is the difference between the two groups on the OxAFQ-C. Secondary study outcomes are radiologic changes in terms of morphology and lesion size, NRS during weight bearing and quality of life measured with a Peds-QL, EQ-5D-y and AAS.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden that patients will have is mainly the time that they have to spent on fulfilling the questionnaires.",[84,85,86,87,88],"Cartilage Injury","Orthopedic Disorder","Skeletal Injury","Rehabilitation","Physiotherapy","NOT_YET_RECRUITING","2024-01-13",{"date":92,"type":93},"2024-01-24","ACTUAL",{"date":95,"type":78},"2024-02-01",{"date":97,"type":78},"2027-07-01",{"name":56,"class":6},2]