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

Recruiting now

Conditions studied: Ankle Sprain

In brief

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.

Key facts

Study ID

NCT04095598

Run by

Hospital Israelita Albert Einstein

People needed

133

Starts

2018-09-01

Expected to finish

2027-12-01

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Hospital Israelista Albert Einstein — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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