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Recruiting NCT04846712

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

Observational Ankle Sprains

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Collect data of medical record.
Who it may be relevant to
Registry conditions: Ankle Sprains. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Severity score by ultrasound (US) assesment [Time frame: Day: 14 after Ankle Sprain.]
Secondary outcome measures (2)
  • Severity score by Magnetic Resonance Imaging (MRI) assesment [Time frame: Day: 14 after Ankle Sprain.]
  • Severity score by radiologist assesment [Time frame: Day: 30, 90, 180, 365 after Ankle Sprain.]

Eligibility criteria

Inclusion criteria

  • First ankle sprain with sport or work disability

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT04846712 · IRBN1382021/CHUSTE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗