Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-08-04
2023-12-04
Brief Summary
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Detailed Description
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"Deltoid Gap Sign" which is the main subject of this study, will be performed in patients firstly at patients' ward i) without pre-operative anesthesia, secondly at operating theatre ii) under anesthesia before the operation. The examination will be carried out by two different physicians and the opinion of both physicians will be noted. Physicians will be blinded and will not know others' decisions.
External rotation stress test (ERST) in dorsiflexion, which is another examination method accepted in the literature in the evaluation of the deltoid ligament, will also be performed by two physicians and the opinions of the physicians will be noted. ERST will be analyzed under fluoroscopy control.
After the examination, open surgery will be performed around the medial malleolus. It will be noted whether the deltoid ligament was injured (ruptured/ not ruptured), which fibers of the deltoid ligament (superficial/deep/superficial + deep fibers) were ruptured.
Statistical ratios such as positive predictive value, negative predictive value, sensitivity, specificity, and likelihood ratio will be calculated based on the results obtained.
Deltoid gap sign will be checked whether it is correlated with ERST and the results will be compared with the ERST.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Positive Group (Rupture and Gap Sign are both positive)
Rupture and Gap Sign are both positive
Deltoid Gap Sign
At first deltoid sign test will be performed and the result of the test will be noted for the patients who are already scheduled open medial ankle surgery due to diagnosed as ankle fracture. During the open surgery, the test results will be evaluated.
Rupture Positive Group (Rupture positive but Gap Sign is negative)
Rupture positive but Gap Sign is negative
Deltoid Gap Sign
At first deltoid sign test will be performed and the result of the test will be noted for the patients who are already scheduled open medial ankle surgery due to diagnosed as ankle fracture. During the open surgery, the test results will be evaluated.
Gap Sign Positive Group (No rupture exists but Gap Sign is positive)
No rupture exists but Gap Sign is positive
Deltoid Gap Sign
At first deltoid sign test will be performed and the result of the test will be noted for the patients who are already scheduled open medial ankle surgery due to diagnosed as ankle fracture. During the open surgery, the test results will be evaluated.
Negative Group (Rupture and Gap sign are both negative)
Rupture and Gap sign are both negative
Deltoid Gap Sign
At first deltoid sign test will be performed and the result of the test will be noted for the patients who are already scheduled open medial ankle surgery due to diagnosed as ankle fracture. During the open surgery, the test results will be evaluated.
Interventions
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Deltoid Gap Sign
At first deltoid sign test will be performed and the result of the test will be noted for the patients who are already scheduled open medial ankle surgery due to diagnosed as ankle fracture. During the open surgery, the test results will be evaluated.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who had been performed an open surgery at the medial malleolus region
* Patients with Maisonneuve fractures
Exclusion Criteria
* Talus fractures
* Patients in pediatric age
18 Years
80 Years
ALL
No
Sponsors
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Goztepe Training and Research Hospital
OTHER
Responsible Party
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Esat UYGUR
Assoc.Prof.M.D.
Locations
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İstanbul Medeniyet University.Göztepe State Hospital
Istanbul, Kadıkoy, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-04
Identifier Type: -
Identifier Source: org_study_id
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