Evaluation of Functional Outcomes at 2 Months According to Therapeutic Management, in Trauma With Low-grade Osteo-ligamentous Ankle Injury in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Activities Scale for Kids (ASKp)
研究概览
简要总结
Lack of current consensus on the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children. Several types of immobilization are evaluated in the literature, with different conclusions. Some teams recommend a functional treatment similar to the adult (with or without strict immobilization), others remain on standard rigid immobilizations.
The goal of the study is to simplify and homogenize the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children.
详细描述
Lack of current consensus on the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children. Several types of immobilization are evaluated in the literature, with different conclusions. Some teams recommend a functional treatment similar to the adult (with or without strict immobilization), others remain on standard rigid immobilizations.
The goal of the study is to simplify and homogenize the therapeutic management of low-grade osteo-ligament injuries in ankle trauma in children.
CHEVIPED is a controlled, randomized, comparative monocentric trial.
Randomization into 2 groups and stratified on presence to fracture Salter 1 and age
Experimental group : Patients with below-knee soft resin cast Control group : Patients with below-knee rigid resin cast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Walking child from 5 to 15 years old.
- •From hour 0 to hour 48 of ankle trauma with torsion mechanism (inversion, eversion or rotation).
- •Patient presenting for the first time to the emergency room for this traumatic episode.
- •Possibility of carrying out an ultrasound during the passage to the emergency room.
- •Child and parents' consent in the study participation
排除标准
- •Pubescent patients requiring anticoagulation (menarche in girls and genital pilosity in boys).
- •Direct shock on the foot without sprain mechanism.
- •Fracture with deformation or open fracture.
- •History of ankle trauma in the last 3 months.
- •Neurological or neuromuscular pathology.
- •Child with a delay in acquisitions and / or psychomotor development (difficulties in understanding and interacting to locate pain).
- •Absence of a representative of parental authority.
- •Constitutional bone disease or connective tissue.
- •Acquired or congenital coagulopathy.
- •Patient presenting beyond 48h of trauma.
- •Polytraumatized.
- •Dermabrasion, wound or sign of skin suffering next to the ankle requiring specific monitoring.
- •Child or parents refusal in study participation
研究组 & 干预措施
Below-knee soft resin cast
Below-knee soft resin cast is administered to participants in emergency department. Investigator puts three layers of jersey supplemented by strips of soft resins to be unrolled along the leg after immersion in warm water
Duration to ankle immobilization with soft resin boot : 21 days.
干预措施: below-knee soft resin cast (Device)
Below-knee rigid resin cast
Below-knee soft resin cast is administered to participants in emergency department. Investigator puts one layer of jersey and then one layer of foam composed by strips of cotton wool to be unrolled supplemented by strips of rigid resins to be unrolled along the leg after immersion in warm water.
Duration to ankle immobilization with soft resin boot : 21 days.
干预措施: Below-knee rigid resin cast (Device)
结局指标
主要结局
Activities Scale for Kids (ASKp)
时间窗: At 2 months
Activities Scale for Kids (ASKp) is a questionnaire about activities from the previous week. It has 30 item with 5 answers : all of the time (the better) / most of the time / sometimes / once in a while / none of the time (the worse).
次要结局
- Comparison between clinical exams and the radiography results.(day 0)
- Comparison between the clinical exams and the ultrasound results.(day 0)
- Parents questionnaire(day 21)
- Numeric Scale (NS)(day 21)
- Clinical exams(day 21)
- Comparison between the radiography results and the ultrasound results.(day 0)
- Intercurrent consultation(between day 0 and day 42)
- Negative predictive value (VPN) of "combined clinical criteria"(day 0)
- Sensitivity and specificity of local skin signs(day 0)
- Visual Analogue Scale (VAS)(day 21)
- injury during removal of the device(between day 0 and day 42)