Interest of Ultrasound in the Diagnosis of Severity of Lateral Ankle Sprain

Recruiting

• Conditions: Ankle Sprains
• Interventions: Other: Collect data of medical record

• Registration Number: NCT04846712
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Ankle sprain is a frequent and widely trivialized trauma. Misdiagnosed or poorly treated, it can recur and thus develop into chronic ankle instability. It can be associated with complications which, if not detected early, can lead to long-term sequelae.

Detailed Description

The hypothesis of this study is that ultrasound can better characterize the severity stages of the sprain and can diagnose complications that may have gone unnoticed on physical examination.

Patients were assessed clinically: demographics, history, clinical examination, functional scores. An ultrasound and an MRI were done during the first month to check for complications. The main objective is to assess the value of ultrasound in the diagnosis of the severity of the lateral ankle sprain. The secondary objective is to compare an ultrasound assessment of severity with a clinical assessment and Magnetic Resonance Imaging (MRI).

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-15
• Study Start: 2021-12-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• First ankle sprain with sport or work disability

Exclusion Criteria

• Patient with fractures, dislocation or hyperlaxity
• Previous ankle sprain

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with a first ankle sprain	Collect data of medical record	50 patients with a first ankle sprain will be included. Data will be collected of medical record.

Primary Outcome Measures

Name	Time	Method
Severity score by ultrasound (US) assesment	Day: 14 after Ankle Sprain.	Collected in medical record.; This system utilises a classification that is based on injury severity related to the amount of tissue damage and associated functional loss. It categorises muscle injuries into three grades, ranging from grade 1 with no appreciable tissue tear, grade 2 with tissue damage and reduced strength of the musculotendinous unit and grade 3 with complete tear of musculotendinous unit and complete loss of function

Secondary Outcome Measures

Name	Time	Method
Severity score by radiologist assesment	Day: 30, 90, 180, 365 after Ankle Sprain.	Collected in medical record.; Empirical score : low, mild, severe
Severity score by Magnetic Resonance Imaging (MRI) assesment	Day: 14 after Ankle Sprain.	Collected in medical record.; This system utilises a classification that is based on injury severity related to the amount of tissue damage and associated functional loss. It categorises muscle injuries into three grades, ranging from grade 1 with no appreciable tissue tear, grade 2 with tissue damage and reduced strength of the musculotendinous unit and grade 3 with complete tear of musculotendinous unit and complete loss of function

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France