NCT04095598 Computed Tomography With Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)
| NCT ID | NCT04095598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Israelita Albert Einstein |
| Condition | Ankle Sprain |
| Study Type | OBSERVATIONAL |
| Enrollment | 133 participants |
| Start Date | 2018-09-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 133 participants in total. It began in 2018-09-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion criteria: * 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 criteria * 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.
Contact & Investigator
João Carlos Rodrigues, MD
PRINCIPAL INVESTIGATOR
Hospital Israelita Albert Einstein
Frequently Asked Questions
Who can join the NCT04095598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ankle Sprain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04095598 currently recruiting?
Yes, NCT04095598 is actively recruiting participants. Contact the research team at joao.rodrigues@einstein.br for enrollment information.
Where is the NCT04095598 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT04095598 clinical trial?
NCT04095598 is sponsored by Hospital Israelita Albert Einstein. The principal investigator is João Carlos Rodrigues, MD at Hospital Israelita Albert Einstein. The trial plans to enroll 133 participants.