Ankle Fractures, Ligament Injury, Ligament Rupture
Conditions
Brief summary
Deltoid Gap Sign which would be a new method of examination for deltoid ligament injuries will be investigated. It will be analyzed if it is correlated with the external rotation stress test. The study is designed as a blinded, comparative and prospective trial.
Detailed description
Ankle fracture patients who applied to our clinic agreed to be included in the study and underwent surgical intervention will participate in the study. The pediatric age group will not be included in the study, since deltoid ligament tears are not common in ankle fractures in pediatric age. However, since this fracture can also be seen in pregnant women, if there is a pregnant patient who will require surgical treatment, they can be included in the study. 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.
Interventions
DIAGNOSTIC_TESTDeltoid 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.
Sponsors
Goztepe Training and Research Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Physicians who will perform the examination will not know other physicians' decisions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who had operated on because of ankle trauma * Patients who had been performed an open surgery at the medial malleolus region * Patients with Maisonneuve fractures
Exclusion criteria
* Medial malleolus fractures * Talus fractures * Patients in pediatric age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the Gap Sign | 24 hours | Gap Sign will be recorded either positive or negative after performing Deltoid Gap Sign. During the open surgery, the rupture of the ligament will be evaluated again. Then sensitivity of Gap Sign will be calculated using Chi Square test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of the Gap Sign | 24 hours | Gap Sign will be recorded either positive or negative after performing Deltoid Gap Sign. During the open surgery, the rupture of the ligament will be evaluated again. Then specificity of Gap Sign will be calculated using Chi Square test. |
| Likelihood ratios of the Gap Sign | 24 hours | Gap Sign will be recorded either positive or negative after performing Deltoid Gap Sign. During the open surgery, the rupture of the ligament will be evaluated again. Then likelihod ratios of Gap Sign will be calculated using Chi Square test. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactEsat UYGUR
Outcome results
None listed