Isolated Syndesmosis Diastasis: Computed Tomography Scan Assessment With Arthroscopic Correlation.
Tae-Keun Ahn, Seung-Myung Choi, Jae-Young Kim...
https://pubmed.ncbi.nlm.nih.gov/28237080/Actively Recruiting
Led by Hospital Israelita Albert Einstein · Updated on 2024-10-17
133
Participants Needed
1
Research Sites
52 weeks
Total Duration
This research aims to find the best way to diagnose syndesmotic instability, a serious type of high ankle sprain involving ligament damage to the distal tibiofibular syndesmosis. The study compares the accuracy of the current standard ankle CT scan in a neutral position with two new CT scans performed under stress conditions with either extended or flexed knees. The goal is to see if these new stress CT methods can detect instability more accurately and to assess participants disability outcomes using the Foot and Ankle Ability Measure questionnaire. Participants undergo three diagnostic imaging tests the existing ankle CT scan in a neutral position and two new CT scans with stress maneuvers one with knees extended and one with knees flexed. In addition, they receive an MRI scan as a reference test. The Foot and Ankle Ability Measure questionnaire is completed at 6 and 12 months after the CT scans to evaluate disability related to foot and ankle function. The imaging exams use specific technical settings to produce detailed images while minimizing radiation exposure. During the study, participants provide demographic data, complete questionnaires, and undergo the imaging tests in a controlled and standardized manner. The study carefully monitors how well the stress maneuvers can be performed, noting any pain, motion artifacts, or need to repeat images. Researchers measure distances between bones in the ankle to identify instability and compare these across the different CT methods. The main outcome measured is the tibiofibular distance over about three years, while secondary outcomes include changes in disability scores and reliability of image readings. Participants remain blinded to group assignments to avoid bias.
CONDITIONS
Computed Tomography with Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)
J
João Carlos Rodrigues, MD
A
Alexandre Leme Godoy Santos, PhD
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Hospital Israelita Albert Einstein
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo comparative ankle imaging exams including CT scans in neutral and stress positions with extended and flexed knees, as well as an MRI to evaluate syndesmotic injury.
1 visit (in-person) for imaging exams
Duration - 12 months
Participants complete the Foot and Ankle Ability Measure (FAAM) questionnaire to assess foot and ankle function and disability at 6 and 12 months after imaging exams.
2 questionnaire assessments (at 6 and 12 months)
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/1907807/Hospital Israelita Albert Einstein
Lead Sponsor