Health TrialsbyHealthPanel

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

ConditionAnkle Sprain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Israelita Albert Einstein

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

All consecutive patients seen at the foot and ankle outpatient clinic of a tertiary hospital with an orthopedic clinical diagnosis of syndesmotic lesion will be eligible to participate in the study.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Comparative Ankle Tomography with Stress Maneuvers

    Diagnostic test

    All diagnostic imaging exams and FAAM questionnaire will be applied in a standard way in both groups.

Treatment groups

133 Participants
are divided into 2 treatment groups
Group A: Syndesmotic injured group1 intervention
Group B: Syndesmotic uninjured group1 intervention

Trial outcomes

Primary outcomes

1

Tibiofibular distance

Measurements of the tibiofibular distance

Time frame
Through the study completion, a average of three years

Secondary outcomes

1

Foot and Ankle Ability Measurement

Functional scale with two subscales (daily life activity and sport) reported separately. The scale range for each subscale varies from the lowest score value (zero) to the highest value (100) in percentage. Higher scores represent a better outcome for both subscales.

Time frame
Change from 6 months to 12 months
2

Interobserver CT agreement reliability

Intraclass correlation coefficient for CT continuous data

Time frame
Through the study completion, a average of three years
3

Interobserver MRI agreement reliability

Kappa coefficient for MRI categorical data

Time frame
Through the study completion, a average of three years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Israelita Albert Einstein

Lead sponsor

Source ClinicalTrials.gov
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