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

Study acronym: CTMETS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2026 → Dec 2028
See other at-risk trials from Hospital Israelita Albert Einstein

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Dec 2028 Show 5 more changesShow less
    • Study completion pushed from Dec 2027 to Dec 2029
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description revised
    • Publications: details revised at 16 of 17 entries
  2. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Dec 2026 to Dec 2027
    • Site details revised
    v6
  3. Primary completion date: Dec 2023 to Dec 2025
    • Study completion date: Dec 2024 to Dec 2026
    v5
  4. Primary completion date: Dec 2022 to Dec 2023
    • Study completion date: Dec 2023 to Dec 2024
    • Study description shortened, about 14 words
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Eligibility criteria expanded, about 12 words
    • Study description shortened, about 8 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04095598
Lead Sponsor Hospital Israelita Albert Einstein
Conditions
(from sponsor)		 Ankle Sprain
Related terms Ankle Injuries
Enrollment 133 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov