Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment133 (estimated)
SponsorHospital Israelita Albert Einstein
Academic / other
Locations1 site (São Paulo, São Paulo)
StatusRecruiting
StartedSeptember 1, 2018
Main results expectedDecember 2028
Study endsDecember 2029
Registry record updatedOctober 7, 2026
Trial IDNCT04095598 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.