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CompletedNCT06856889PFEECUpdated Feb 25, 2026

Systematic Ultrasound in the Initial Assessment of Ankle Sprain

An observational study in Ankle Sprain, sponsored by Hopital Nord Franche-Comte. Completed at 1 site in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Hopital Nord Franche-Comte · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
13
Ages
15 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ankle Sprain

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Keywords

  • ultrasound scan
03

In context

Ankle Injuries

350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.

This study's enrollment of 13 is below the median of 84 across 73 observational studies indexed under Ankle Injuries.

Browse Ankle Injuries studies →

Lead sponsor

Hopital Nord Franche-Comte is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with ankle sprain

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
13 participants (actual)
Patient registry
No

Groups and cohorts

  • Control group

    no ultrasound scan

  • Experimental groupe

    ultrasound scan

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

1 site
  • Maison Médicale des Bords de Seille
    Bletterans, 39140, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2025 to primary completion in Dec 2025, 8 months.

Of 34 non-industry observational studies under Ankle Injuries, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 45. This study's 8 months is below that.

Counting every sponsor, half of 38 studies reached it within 11 months; a quarter within 5 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2025
First posted
Mar 4, 2025
StartActual
Mar 7, 2025
Primary completionActual
Dec 2, 2025
CompletionActual
Dec 2, 2025
Last update
Feb 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06856889
Lead sponsor
Hopital Nord Franche-Comte
Responsible party
Sponsor
First posted
Mar 4, 2025
Start date
Mar 7, 2025
Primary completion
Dec 2, 2025
Completion
Dec 2, 2025
Last update
Feb 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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