About this trial

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.

Objective: 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.

Study design: Observational comparative study

Study population: Skeletally immature children with an osteochondral lesion of the talus diagnosed on CT.

Intervention: 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.

Main study parameters/endpoints: 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.

Nature 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.

Eligibility criteria

Qualifiers

Symptomatic, osteochondral lesion of the talus

Diagnosed on Computed Tomography (CT)

Open physes of the distal tibia confirmed by a specialized musculoskeletal or pediatric radiologist

Age ≥4 and ≤18

Disqualifiers

acute traumatic lesions

surgically treated OLTs

systemic diseases that can influence cartilage conditions (such as hemophilia)

Trial design

Treatments tested in this trial

  • Casting and supervised rehabilitation

Treatment groups

76 Participants
are divided into 2 treatment groups

Locations

2
Amphia Hospital Breda4818CK, BredaMolengracht 21, Netherlands
Amsterdam UMC1071 TS, Amsterdam Netherlands

Sponsors and collaborators

Tristan Buck

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor institution

Emma Childrens Hospital Foundation

Collaborator

European Paediatric Orthopaedic Society (EPOS)

Collaborator