[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skeletal-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skeletal-injury":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":22,"type":23},76,"ESTIMATED","INTERVENTIONAL",[26],"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.",[29,30,31,32,33],"Cartilage Injury","Orthopedic Disorder","Skeletal Injury","Rehabilitation","Physiotherapy","NOT_YET_RECRUITING","2024-01-13",{"date":37,"type":38},"2024-01-24","ACTUAL",{"date":40,"type":23},"2024-02-01",{"date":42,"type":23},"2027-07-01",{"name":44,"class":45},"Tristan Buck","OTHER",2]