A New Method for Deltoid Ruptures: Gap Sign

Ankle Fractures Clinical Trial

Official title:

A Novel Examination Method for Deltoid Injuries: Deltoid Gap Sign

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188391
• Other study ID #: 2021-04
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: December 4, 2023

Study information

• Verified date: March 2023
• Source: Goztepe Training and Research Hospital
• Contact: Esat UYGUR
• Phone: +905556916122
• Email: esatuygur[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 4, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Ligament Injury
• Ligament Rupture
• Rupture

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University.Göztepe State Hospital	Istanbul	Kadikoy

Sponsors (1)

Lead Sponsor	Collaborator
Goztepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the Gap Sign	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.	24 hours
Secondary	Specificity of the Gap Sign	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.	24 hours
Secondary	Likelihood ratios of the Gap Sign	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.	24 hours