Evaluating ankle sprains using advanced CT imaging techniques
Comparative Computed Tomography with Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability in Adults After Acute Ankle Sprain: a Test Accuracy Study
Hospital Israelita Albert Einstein · NCT04095598
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 |
|---|---|
| Enrollment | 133 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Israelita Albert Einstein (other) |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT04095598 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with bilateral ankle sprains, previous ankle surgeries, or other specific ankle conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
São Paulo, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ankle Sprain, High ankle sprain, Syndesmotic instability, Computed Tomography, Stress maneuver