Clinical trial NCT05188391: A New Method for Deltoid Ruptures: Gap Sign
Official title: A Novel Examination Method for Deltoid Injuries: Deltoid Gap Sign
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Fractures
Ligament Rupture
Ligament Injury
Lead sponsor: Goztepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of the Gap Sign
timeFrame: 24 hours
Secondary outcomes:
measure: Specificity of the Gap Sign
timeFrame: 24 hours
measure: Likelihood ratios of the Gap Sign
timeFrame: 24 hours
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Medeniyet University.Göztepe State Hospital
state: Kadıkoy
Study officials:
References: