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Inclusion of patients very limited due to lack of time and human resources dedicated to research.
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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 :
200 patients are expected to be included.
Inclusion period : 12 months. Duration of patient's participation: 2 months Total study duration: 14 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Below-knee soft resin cast | Experimental | 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. |
|
| Below-knee rigid resin cast | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| below-knee soft resin cast | Device | Patients have soft resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 0 |
| Visual Analogue Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Brest | Brest | 29609 | France |
All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.
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Monocentric, randomized, non-inferiority, without blinding, controlled trial with 2 parallel groups
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| Below-knee rigid resin cast | Device | Patients have rigid resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1) |
|
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.
| 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) | 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) | day 21 |
| Clinical exams | Clinical exams are exams administered by investigator during a consultation. There are four exams :
| day 0 |
| Clinical exams | Clinical exams are exams administered by investigator during a consultation. There are four exams :
| day 21 |
| Parents questionnaire | It is a questionnaire for parents that assesses the feeling about the children care, with 3 questions. | day 21 |
| Intercurrent consultation | Adjudicated intercurrent consultation (Other medical consultation than those planned) during the study treatment period | between day 0 and day 42 |
| injury during removal of the device | Adjudicated injury during removal of the device during the study treatment period | 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. | 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. | 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) | 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) . | 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) . | day 0 |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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