Actively Recruiting

Age: 18Years +
All Genders
NCT04095598

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

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

133

Participants Needed

1

Research Sites

482 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The main aim of this study was to investigate which strategy can diagnose more accurately syndesmotic instability among an existing index test (ankle CT in neutral position) and two new add-on index tests (ankle CT in a stress position with extended-knees and ankle CT in a stress position with flexed-knees). This study hypothesized that the two add-on ankle CT with stress maneuvers (CTSM) have a more accurate capability of diagnosing syndesmotic instability than ankle CT in a neutral position (CTNP) alone. The secondary objective is to investigate the participants' disability outcomes by applying the Foot and Ankle Ability Measure questionnaire.

CONDITIONS

Official 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

AI-Powered Screening

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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

CONTACT

A

Alexandre Leme Godoy Santos, PhD

CONTACT

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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