RecruitingNCT04095598

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

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


Sponsor

Hospital Israelita Albert Einstein

Enrollment

133 participants

Start Date

Sep 1, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

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Interventions

DIAGNOSTIC_TESTComparative Ankle Tomography with Stress Maneuvers

All diagnostic imaging exams and FAAM questionnaire will be applied in a standard way in both groups.


Locations(1)

Hospital Israelista Albert Einstein

São Paulo, São Paulo, Brazil

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