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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Oxford Ankle Foot Questionnaire for Children (OxAFQ-C), physical domain
研究概览
简要总结
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.
详细描述
STUDY DESIGN After the diagnostic process in the outpatient clinics, patients will be counseled for both options, ''skill-full'' neglect or casting and supervised rehabilitation in a shared decision makig process. This process includes the choice talk, option talk, and decision talk. After the decision, patients will be placed in group one or two based on their preference.
Treatment groups Group 1: 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.
Group 2: 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.
STUDY POPULATION Population (base) All patients, up from June 2023, visiting the outpatient clinic of the orthopedic department in one of the participating hospitals will be screened for eligibility to participate in this study. Patients ≥4 years are considered as eligible as it is observed that OLTs can occur in this young population as well. In order to make the results of this study generalizable to this population and to optimize their treatment, it is decided to include this young patient group. If patients are eligible, they, and their caretakers will be informed about this study. After confirmation, patients will be allocated to one of the two groups. There are no restrictions on the number of inclusions per center.
Sample size calculation The sample size is calculated based on a minimally important difference of 17% in the OxAFQ-C physical domain. For this sample size calculation, a SD of 25 is used. A calculated sample size of 35 patients in each group is needed for an 80% study power. To compensate for potential loss to follow up of 7.5%, 38 patients will be included in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •acute traumatic lesions
- •surgically treated OLTs
- •systemic diseases that can influence cartilage conditions (such as hemophilia)
结局指标
主要结局
Oxford Ankle Foot Questionnaire for Children (OxAFQ-C), physical domain
时间窗: 1 year
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.
次要结局
- Radiological outcome (bone marrow edema)(1 year)
- Numeric Rating Scale (NRS) during weightbearing(1 year)
- Radiological outcome (lesion morphology)(1 year)
- Radiological outcome (lesion size)(1 year)
- Return to Sport (time)(1 year)
- EuroQol Five Dimensions Health Questionnaire Youth (EQ5D-Y)(1 year)
- Pediatric Quality of Life Inventory(1 year)
- Return to Sport (level)(1 year)
研究者
Tristan Buck
PhD candidate, MD, MSc
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)