Evaluation of Functional Outcomes at 2 Months According to Therapeutic

Status Terminated

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

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Clinical Trial Details

NCT number	NCT05009342
Study type	Interventional
Source	University Hospital, Brest
Contact
Status	Terminated
Phase	N/A
Start date	September 9, 2021
Completion date	June 9, 2023

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms