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.
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. The primary objective is to demonstrate at 2 months that with post traumatic low- grade osteo-ligamentous ankle injury the recovery of physical function are at least as effective with a below-knee soft resin cast compared to a below-knee rigid resin cast. The secondary objectives are : 1. Clinical evaluation of treatment at 3 weeks in immediate post-immobilization. 2. Evaluation of the management satisfaction (effectiveness and understanding) and the treatment tolerance . 3. Evaluation of the time taken to resume painless support after immobilization. 4. Point of interest evaluation 5. Determine the diagnostic performance of the "combined clinical criteria" in comparison with the ultrasound/radiography couple. 6. Evaluation of the diagnostic performance of clinical inspection criteria (edema, bruise) in high-grade ligament damage. 7. Evaluation of the link between the "combined clinical criteria" and the results of the radiography. 8. Evaluation of the relationship between "combined clinical criteria" and ultrasound results. 9. Evaluation of the link between the results of radiography and ultrasound. 200 patients are expected to be included. Inclusion period : 12 months. Duration of patient's participation: 2 months Total study duration: 14 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Patients have soft resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)
Patients have rigid resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)
CHU de Brest
Brest, France
Activities Scale for Kids (ASKp)
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).
Time frame: At 2 months
Visual Analogue Scale (VAS)
It is a scale that measures pain intensity with small ruler, between 0 (no pain) to 10 (severe pain). It can be administered for children 4 to 6 years old.
Time frame: day 0
Visual Analogue Scale (VAS)
It is a scale that measures pain intensity with small ruler, between 0 (no pain) to 10 (severe pain). It can be administered for children 4 to 6 years old.
Time frame: day 21
Numeric Scale (NS)
It is a scale that mesures pain intensity. Children aged to 4 to 6 years gives a grade between 0 (no pain) to 10 (severe pain)
Time frame: day 0
Numeric Scale (NS)
It is a scale that measures pain intensity. Children aged to 4 to 6 years gives a grade between 0 (no pain) to 10 (severe pain)
Time frame: day 21
Clinical exams
Clinical exams are exams administered by investigator during a consultation. There are four exams : 1. inspection : presence or not of a hematoma and oedema 2. palpation : pain or not with palpation 3. mobilization : 3 items with 2 answers (Yes/No) 4. support capacity : 2 items with 2 answers (Yes/No)
Time frame: day 0
Clinical exams
Clinical exams are exams administered by investigator during a consultation. There are four exams : 1. inspection : presence or not of a hematoma and oedema 2. palpation : pain or not with palpation 3. mobilization : 3 items with 2 answers (Yes/No) 4. support capacity : 2 items with 2 answers (Yes/No)
Time frame: day 21
Parents questionnaire
It is a questionnaire for parents that assesses the feeling about the children care, with 3 questions.
Time frame: day 21
Intercurrent consultation
Adjudicated intercurrent consultation (Other medical consultation than those planned) during the study treatment period
Time frame: between day 0 and day 42
injury during removal of the device
Adjudicated injury during removal of the device during the study treatment period
Time frame: between day 0 and day 42
Negative predictive value (VPN) of "combined clinical criteria"
Negative predictive value (VPN) of "combined clinical criteria" in the detection of low-grade bone or ligament damage to the ankle in children compared to ultrasound/radiography.
Time frame: day 0
Sensitivity and specificity of local skin signs
Sensitivity and specificity of local skin signs (INSPECTION line of the clinical examination questionnaire) to detect high-grade ligament damage on ultrasound.
Time frame: day 0
Comparison between clinical exams and the radiography results.
Clinical exams are exams administred by investigator during a consultation (inspection, palpation, mobilization, support capacity).The results of this exams are compared to radiography results at the inclusion (origin and localization of injury)
Time frame: day 0
Comparison between the clinical exams and the ultrasound results.
Clinical exams are exams administred by investigator during a consultation (inspection, palpation, mobilization, support capacity).The results of this exams are compared to ultrasound results at the inclusion (origin and localization of injury) .
Time frame: day 0
Comparison between the radiography results and the ultrasound results.
Ultrasound results are compared to radiography results at the inclusion (origin and localization of injury) .
Time frame: day 0
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