Evaluation of Functional Outcomes at 2 Months According to Therapeutic Management, in Trauma With Low-grade Osteo-ligamentous Ankle Injury in Children (CHEVIPED)

Regional University Hospital Center (CHRU)

Status: Terminated

Conditions: Ligament Injury; Ankle Injuries

Treatments: Device: Below-knee rigid resin cast; Device: below-knee soft resin cast

Study type: Interventional

Funder types: Other

Identifiers

NCT05009342

29BRC21.0016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Below-knee soft resin cast

Experimental group

Description:

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.

Treatment:

Device: below-knee soft resin cast

Below-knee rigid resin cast

Other group

Description:

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.

Treatment:

Device: Below-knee rigid resin cast