Evaluating ankle sprains using advanced CT imaging techniques
Official title: Comparative Computed Tomography With Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability in Adults After Acute Ankle Sprain: a Test Accuracy Study
Run by Hospital Israelita Albert Einstein · NCT04095598 · Data updated 2026-11-12
This study is testing new CT imaging techniques to see if they can better diagnose high ankle sprains and help improve treatment for patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 133 (estimated) |
| Sponsor | Hospital Israelita Albert Einstein Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | September 1, 2018 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT04095598 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 who have experienced a single episode of ankle sprain within the last three weeks and have a positive orthopedic evaluation for suspected syndesmotic injury.
✕Probably not a fit
Patients with bilateral ankle sprains, previous ankle surgeries, or other specific ankle conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of different computed tomography (CT) imaging strategies for diagnosing syndesmotic instability in patients with high ankle sprains. It compares the standard CT in a neutral position with two new techniques that involve stress maneuvers to determine which method provides a more accurate diagnosis. Additionally, the study aims to assess the disability outcomes of participants using the Foot and Ankle Ability Measure questionnaire. By improving diagnostic accuracy, the study seeks to enhance treatment decisions for patients with ankle sprains.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of syndesmotic injuries, resulting in better treatment outcomes for patients.
How similar studies have gone: While there is limited evidence on the effectiveness of stress maneuvers in CT imaging for this specific condition, the study aims to explore a novel approach that has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Adults older than 18 years; * One episode of an ankle sprain; * Sprain episode occurred up to 3 weeks prior; * Positive orthopedic evaluation for suspected syndesmotic injury. Exclusion criteria * Bilateral ankle sprain; * Previous ankle surgery; * Ankle fractures and dislocations (except avulsion fractures in ligamentous insertions or fracture of the posterior malleolus related to syndesmotic injury); * Congenital or acquired ankle deformities; * Infection, inflammatory, or neuropathic ankle arthropathies.
Where it's running
-
Hospital Israelista Albert Einstein
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Principal investigator: João Carlos Rodrigues, MD — Hospital Israelita Albert Einstein
- Study coordinator: João Carlos Rodrigues, MD
- Email: joao.rodrigues@einstein.br
- Phone: 51121512452
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.