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

NCT04846712 | Recruiting

• 1 other identifier: IRBN1382021/CHUSTE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprains

Keywords

Ankle; sprain; diagnosis; ultrasound; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Severity score by Magnetic Resonance Imaging (MRI) assesment

  Day: 14 after Ankle Sprain.

• Severity score by radiologist assesment

  Day: 30, 90, 180, 365 after Ankle Sprain.

Study Arms (1)

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

Interventions

Collect data of medical record OTHER

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.

patients with a first ankle sprain

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a first ankle sprain will be included.

You may qualify if:

• First ankle sprain with sport or work disability

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Ankle Injuries; Sprains and Strains; Disease

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas NERI, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas NERI, MD

CONTACT

(0)477127849; thomas.neri@chu-st-etienne.fr

Davy VEYRE, resident

CONTACT

(0)477127849; davy.veyre89@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: December 1, 2021
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)