Abstract
BACKGROUND: Skeletally immature osteochondral lesions of the talus (OLTs) have a significant impact on the health status and quality of life of pediatric patients and the involved family. the current literature showed success in 4 out of 10 patients but it is currently unknown which type of non-operative management showed better clinical- and radiological outcomes. The aim of this study is to compare immobilization and supervised rehabilitation with a 'skillful'' neglect in the treatment for skeletally immature patients with an OLT. The hypothesis is that a period of immobilization and supervised rehabilitation will lead to better clinical and radiological outcomes compared to ''skillful'' neglect. METHODS: Multicenter, prospective, comparative study. Skeletally immature children with an OLT will be assigned to the intervention or control group after a shared decision-making process. Patients in the intervention group will undergo a 4-week period of immobilization with normal casting and non-weightbearing, which is followed by 4 weeks of immobilization with a removable cast and weight bearing boot. Afterwards, they will receive a protocolled period of rehabilitation under supervision of a physical therapist. The control group will have a 'skillful'' neglect treatment. The main study outcome is the difference between the two groups on the Oxford Ankle and Foot Questionnaire for Children (OxAFQ-C). Secondary study outcomes are radiologic changes in terms of morphology and lesion size. Numeric Rating Scale (NRS) during weight bearing and quality of life measured with a Pediatrics Quality of Life (Peds-QL) and EuroQol-5 Dimension youth (EQ-5D-y). DISCUSSION: This protocol reports on the study design of the CARE Study and it aims to setup a study for evaluating different types of non-operative management in pediatric patients suffering an OLT. This study will compare clinical and radiological outcomes between two different non-operative strategies for treating OLTs in the skeletally immature population. Based on the results of this study, an evidence-based treatment protocol for non-operative management for pediatric OLTs can be provided. TRIAL REGISTRATION: This study is registered in the International Clinical Trial Registry Platform (ICTRP) with trial number NLOMON54282, date of registration 05192023.