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OpenTrials
Completed

NCT Number: NCT06856889

Systematic Ultrasound in the Initial Assessment of Ankle Sprain

Ankle sprains are the most frequently encountered trauma in emergency and general medicine. Lateral ankle sprain injuries have the highest relapse rate of all musculoskeletal injuries of the lower limbs. Optimal initial management is essential for a successful return to previous condition, with the aim of preventing chronic ankle instability, chronic pain, stiffness or recurrence. One of the 13 physicians at our facility routinely performs an ultrasound routinely scan during the second consultation to assess the severity of the sprain. We would therefore like to evaluate whether the performance of this examination at the time of clinical reassessment is associated with a better prognosis at 3 months post-trauma.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maison Médicale des Bords de Seille

Bletterans, 39140, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of ankle sprain made during a preliminary prior consultation
  • Patients undergoing re-evaluation of sprain severity, between D3 and D6 of trauma

Exclusion criteria

  • Medial sprain
  • Sprain recurrence <6 months
  • Age < 15 years
  • Radiographic fracture confirmed on an X-ray performed between initial diagnosis and re-evaluation visit
  • History of hyperlaxity syndrome

Treatment and study plan

Primary outcomes

  1. Value of systematic ultrasound in the initial assessment of ankle sprains on patients' quality of life and sporting activities at 3 months post-injury trauma.

    Time frame: 3 months

    Comparison of ankle-specific quality of life in terms of activities of daily living and sporting activities. This criterion will be measured using the FAAM (Foot and Ankle Ability Measure), a specific questionnaire functional evaluation of the ankle in these activities.

Sponsors and collaborators

Lead sponsor

Hopital Nord Franche-Comte

Other

Registry information

Official study title

Evaluation of the Value of Systematic Ultrasound in the Initial Assessment of Ankle Sprain on Functional Prognosis at 3 Months in the General Population: Pilot Observational Study (PFEEC)

Acronym: PFEEC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Feb 25, 2026

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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