Clinical trial NCT05009342: Evaluation of Functional Outcomes at 2 Months According to Therapeutic Management, in Trauma With Low-grade Osteo-ligamentous Ankle Injury in Children
Official title: Evaluation of Functional Outcomes at 2 Months According to Therapeutic Management, in Trauma With Low-grade Osteo-ligamentous Ankle Injury in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ankle Injuries
Ligament Injury
Keywords: low-grade
osteo-ligament injuries
children
soft resin ankle brace
Below-knee rigid resin cast
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, randomized, non-inferiority, without blinding, controlled trial with 2 parallel groups
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Activities Scale for Kids (ASKp)
timeFrame: At 2 months
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: day 0
measure: Visual Analogue Scale (VAS)
timeFrame: day 21
measure: Numeric Scale (NS)
timeFrame: day 0
measure: Numeric Scale (NS)
timeFrame: day 21
measure: Clinical exams
timeFrame: day 0
measure: Clinical exams
timeFrame: day 21
measure: Parents questionnaire
timeFrame: day 21
measure: Intercurrent consultation
timeFrame: between day 0 and day 42
measure: injury during removal of the device
timeFrame: between day 0 and day 42
measure: Negative predictive value (VPN) of "combined clinical criteria"
timeFrame: day 0
measure: Sensitivity and specificity of local skin signs
timeFrame: day 0
measure: Comparison between clinical exams and the radiography results.
timeFrame: day 0
measure: Comparison between the clinical exams and the ultrasound results.
timeFrame: day 0
measure: Comparison between the radiography results and the ultrasound results.
timeFrame: day 0
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References: