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

NCT06220539 | Not Yet Recruiting DMC

• 1 other identifier: NL78874.018.22
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cartilage Injury; Orthopedic Disorder; Skeletal Injury; Rehabilitation; Physiotherapy

Outcome Measures

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.

  1 year

Secondary Outcomes (8)

• Numeric Rating Scale (NRS) during weightbearing

  1 year

• Pediatric Quality of Life Inventory

  1 year

• EuroQol Five Dimensions Health Questionnaire Youth (EQ5D-Y)

  1 year

• Return to Sport (level)

  1 year

• Return to Sport (time)

  1 year

Study Arms (2)

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

Other: Casting and supervised rehabilitation

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.

Interventions

Casting and supervised rehabilitation OTHER

casting (8 weeks) followed by supervised rehabilitation

Casting and Supervised Rehabilitation

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• acute traumatic lesions
• surgically treated OLTs
• systemic diseases that can influence cartilage conditions (such as hemophilia)

Sponsors & Collaborators

• Tristan Buck: lead
• Emma Childrens Hospital Foundation: collaborator
• European Paediatric Orthopaedic Society (EPOS): collaborator

Study Sites (2)

Amphia Hospital Breda

Breda, Molengracht 21, 4818CK, Netherlands

Location

Amsterdam UMC

Amsterdam, 1071 TS, Netherlands

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD candidate, MD, MSc

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: January 24, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

NL (2)