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

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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Sprains
• Intervention / Treatment: Other: Collect data of medical record

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Thomas NERI, MD; Phone Number: +33 (0)477127849; Email: thomas.neri@chu-st-etienne.fr
• Study Contact Backup: Name: Davy VEYRE, resident; Phone Number: +33 (0)477127849; Email: davy.veyre89@gmail.com

Study Locations

• France
  • Saint-Étienne, France
    • Recruiting
    • CHU Saint-Etienne
    • Principal Investigator: Thomas NERI, MD
    • Sub-Investigator: Davy VEYRE, resident
    • Sub-Investigator: Sylvain Grange, MD
    • Sub-Investigator: Benoît BOUTHIN, MD
    • Sub-Investigator: Clément FOSCHIA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a first ankle sprain will be included.

Description

Inclusion Criteria:

• First ankle sprain with sport or work disability

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with a first ankle sprain; 50 patients with a first ankle sprain will be included. Data will be collected of medical record.	Other: Collect data of medical record; Collect data of medical record: initial physical examination, ultrasound (US), Magnetic Resonance Imaging (MRI), physical examination at 30 days, physical examination at 3 months, physical examination at 6 months and final examination at 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity score by ultrasound (US) assesment	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	Day: 14 after Ankle Sprain.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity score by Magnetic Resonance Imaging (MRI) assesment	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	Day: 14 after Ankle Sprain.
Severity score by radiologist assesment	Collected in medical record. Empirical score : low, mild, severe	Day: 30, 90, 180, 365 after Ankle Sprain.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Thomas NERI, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: MRI; ultrasound; diagnosis; sprain; Ankle
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: IRBN1382021/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No