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NCT Number: NCT04846712

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.

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Key information

Conditions

Ankle Sprains Ankle Injuries Disease Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First ankle sprain with sport or work disability

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Severity score by ultrasound (US) assesment

    Time frame: 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 outcomes

  1. Severity score by Magnetic Resonance Imaging (MRI) assesment

    Time frame: 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

  2. Severity score by radiologist assesment

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

    Collected in medical record.

    Empirical score : low, mild, severe

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Apr 15, 2021
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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