Actively Recruiting

Age: 18Years +
All Genders
ID04095598

Comparative Computed Tomography with Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability in Adults After Acute Ankle Sprain: a Test Accuracy Study

Led by Hospital Israelita Albert Einstein · Updated on 2024-10-17

133

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to find the best way to diagnose syndesmotic instability, a serious type of high ankle sprain involving ligament damage to the distal tibiofibular syndesmosis. The study compares the accuracy of the current standard ankle CT scan in a neutral position with two new CT scans performed under stress conditions with either extended or flexed knees. The goal is to see if these new stress CT methods can detect instability more accurately and to assess participants' disability outcomes using the Foot and Ankle Ability Measure questionnaire. Participants undergo three diagnostic imaging tests: the existing ankle CT scan in a neutral position and two new CT scans with stress maneuvers (one with knees extended and one with knees flexed). In addition, they receive an MRI scan as a reference test. The Foot and Ankle Ability Measure questionnaire is completed at 6 and 12 months after the CT scans to evaluate disability related to foot and ankle function. The imaging exams use specific technical settings to produce detailed images while minimizing radiation exposure. During the study, participants provide demographic data, complete questionnaires, and undergo the imaging tests in a controlled and standardized manner. The study carefully monitors how well the stress maneuvers can be performed, noting any pain, motion artifacts, or need to repeat images. Researchers measure distances between bones in the ankle to identify instability and compare these across the different CT methods. The main outcome measured is the tibiofibular distance over about three years, while secondary outcomes include changes in disability scores and reliability of image readings. Participants remain blinded to group assignments to avoid bias.

CONDITIONS

Brief Title

Computed Tomography with Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - Up to 3 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo comparative ankle imaging exams including CT scans in neutral and stress positions with extended and flexed knees, as well as an MRI to evaluate syndesmotic injury.

1 visit (in-person) for imaging exams

Long-term Monitoring

Duration - 12 months

Participants complete the Foot and Ankle Ability Measure (FAAM) questionnaire to assess foot and ankle function and disability at 6 and 12 months after imaging exams.

2 questionnaire assessments (at 6 and 12 months)

Trial Site Locations

Total: 1 location

1

Hospital Israelista Albert Einstein

São Paulo, São Paulo, Brazil, 05652-900

Actively Recruiting

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Research Team

J

João Carlos Rodrigues, MD

A

Alexandre Leme Godoy Santos, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Conservative and surgical management of acute isolated syndesmotic injuries: ESSKA-AFAS consensus and guidelines.

C Niek van Dijk, Umile Giuseppe Longo, Mattia Loppini...

https://pubmed.ncbi.nlm.nih.gov/26846658

Classification and diagnosis of acute isolated syndesmotic injuries: ESSKA-AFAS consensus and guidelines.

C Niek van Dijk, Umile Giuseppe Longo, Mattia Loppini...

https://pubmed.ncbi.nlm.nih.gov/26704800

External rotation stress imaging in syndesmotic injuries of the ankle: comparison of lateral radiography and radiostereometry in a cadaveric model.

Annechien Beumer, Edward R Valstar, Eric H Garling...

https://pubmed.ncbi.nlm.nih.gov/12807330