A New Method for Deltoid Ruptures: Gap Sign

Goztepe Training and Research Hospital

Status: Enrolling

Conditions: Ligament Rupture; Ligament Injury; Ankle Fractures

Treatments: Diagnostic Test: Deltoid Gap Sign

Study type: Interventional

Funder types: Other

Identifiers

NCT05188391

2021-04

Details and patient eligibility

About

"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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 4 patient groups

Positive Group (Rupture and Gap Sign are both positive)

Other group

Description:

Rupture and Gap Sign are both positive

Treatment:

Diagnostic Test: Deltoid Gap Sign

Rupture Positive Group (Rupture positive but Gap Sign is negative)

Other group

Description:

Rupture positive but Gap Sign is negative

Treatment:

Diagnostic Test: Deltoid Gap Sign

Gap Sign Positive Group (No rupture exists but Gap Sign is positive)

Other group

Description:

No rupture exists but Gap Sign is positive

Treatment:

Diagnostic Test: Deltoid Gap Sign

Negative Group (Rupture and Gap sign are both negative)

Other group

Description:

Rupture and Gap sign are both negative

Treatment:

Diagnostic Test: Deltoid Gap Sign