Systematic Ultrasound in the Initial Assessment of Ankle Sprain

NCT06856889 | Completed

• 1 other identifier: 2024-12-PFEEC
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Sprain

Keywords

ultrasound scan

Outcome Measures

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.

  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

Study Arms (2)

Control group

no ultrasound scan

Experimental groupe

ultrasound scan

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with ankle sprain

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Nord Franche-Comte: lead

Study Sites (1)

Maison Médicale des Bords de Seille

Bletterans, 39140, France

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 7, 2025
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)