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

Ankle Sprains Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04846712
• Other study ID #: IRBN1382021/CHUSTE
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: September 2027

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Thomas NERI, MD
• Phone: (0)477127849
• Email: thomas.neri[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2027
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• First ankle sprain with sport or work disability

Exclusion Criteria:

• Patient with fractures, dislocation or hyperlaxity

• Previous ankle sprain

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Sprains and Strains

Intervention

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.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Severity score by radiologist assesment	Collected in medical record.; Empirical score : low, mild, severe	Day: 30, 90, 180, 365 after Ankle Sprain.