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

NCT ID: NCT05009342

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2023-06-09

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.

Conditions

Ankle Injuries; Ligament Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

below-knee soft resin cast

Intervention Type: DEVICE

Patients have soft resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)

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.

Group Type: OTHER

Below-knee rigid resin cast

Intervention Type: DEVICE

Patients have rigid resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)

Interventions

below-knee soft resin cast

Patients have soft resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)

Intervention Type: DEVICE

Below-knee rigid resin cast

Patients have rigid resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Brest

Brest, , France

Countries

France

Other Identifiers

29BRC21.0016

Identifier Type: -

Identifier Source: org_study_id