A New Method for Deltoid Ruptures: Gap Sign

Not Applicable

Recruiting

• Conditions: Ankle Fractures; Ligament Injury; Ligament Rupture

• Registration Number: NCT05188391
• Lead Sponsor: Goztepe Training and Research Hospital

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.

Study Timeline

• Study Start: 2021-08-04
• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2021-12-27
• Study First Posted: 2022-01-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07
• Primary Completion: 2023-08-04
• Study Completion: 2023-12-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

İstanbul Medeniyet University.Göztepe State Hospital; 🇹🇷 İstanbul, Kadıkoy, Turkey