Systematic Ultrasound in the Initial Assessment of Ankle Sprain (PFEEC)

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)

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.

Study Overview

• Status: Completed
• Conditions: Ankle Sprain

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• France
  • Bletterans, France, 39140
    • Maison Médicale des Bords de Seille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with ankle sprain

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control group; no ultrasound scan
Experimental groupe; ultrasound scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 months

Collaborators and Investigators

• Sponsor: Hopital Nord Franche-Comte

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Actual): December 2, 2025
• Study Completion (Actual): December 2, 2025

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ultrasound scan
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: 2024-12-PFEEC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No