Clinical Trial

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

Study acronym: CTMETS
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-09-18; most recent amendment 2024-10-15.
Trial Details
NCT Number NCT04095598
Lead Sponsor Hospital Israelita Albert Einstein
Conditions Ankle Sprain
Enrollment 133 participants
Start Date 2018-09-01
Primary Completion 2026-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2024-10-17