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CAsting and REhabilitation Versus Supervised Neglect for Osteochondral Lesions of the Talus in the Pediatric Population

ConditionsCartilage InjuryOrthopedic DisorderSkeletal InjuryRehabilitationPhysiotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorTristan Buck

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Casting and supervised rehabilitation

    Other intervention

    casting (8 weeks) followed by supervised rehabilitation

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Casting and Supervised RehabilitationExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Oxford Ankle Foot Questionnaire for Children (OxAFQ-C), physical domain

The response options to each item are on a 5-point scale rated from never (4), rarely (3), sometimes (2), very often (1) to always (0), where the number in brackets represents the value that should be applied by the scorer to each response. Domain scores are calculated as the total of the scale item scores divided by the maximum for each domain. Scores are ranged between 0-100. Higher scores represents better functioning.

Time frame
1 year

Secondary outcomes

1

Numeric Rating Scale (NRS) during weightbearing

pain severity during weightbearing using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.

Time frame
1 year
2

Pediatric Quality of Life Inventory

It is composed of 23 items that gauge function in the following four areas: physical (eight items), emotional (five items), social (five items), and school (five items). Patients report their function using a 5-point Likert scale ranging from 0 to 4. These responses are reverse scored and linearly transformed to a 0 to 100 scale, with a higher score indicating a higher QOL.

Time frame
1 year
3

EuroQol Five Dimensions Health Questionnaire Youth (EQ5D-Y)

The EQ-5D-Y descriptive system comprises the following five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the younger patient's health state. This questionnaire reports the overall health of an individual on a 0% to 100% scale.

Time frame
1 year
4

Return to Sport (level)

Lower-, same-, higher level than pre-injury

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: