A New Method for Deltoid Ruptures: Gap Sign

A Novel Examination Method for Deltoid Injuries: Deltoid Gap Sign

"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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Fractures; Ligament Rupture; Ligament Injury
• Intervention / Treatment: Diagnostic test: Deltoid Gap Sign

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esat UYGUR; Phone Number: +905556916122; Email: esatuygur@gmail.com

Study Locations

• Turkey
  • Kadıkoy
    • İstanbul, Kadıkoy, Turkey, 34732
      • Recruiting
      • İstanbul Medeniyet University.Göztepe State Hospital
      • Contact: Esat UYGUR; Phone Number: +905556916122; Email: esatuygur@gmail.com
      • Contact: Esat UYGUR; Phone Number: 05556916122; Email: esatuygur@gmail.com
      • Sub-Investigator: Oğuzhan Özyaman, Resident

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Positive Group (Rupture and Gap Sign are both positive); Rupture and Gap Sign are both positive	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.; Other Names: Open (visual) Examination of the ligament
Other: Rupture Positive Group (Rupture positive but Gap Sign is negative); Rupture positive but Gap Sign is negative	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.; Other Names: Open (visual) Examination of the ligament
Other: Gap Sign Positive Group (No rupture exists but Gap Sign is positive); No rupture exists but Gap Sign is positive	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.; Other Names: Open (visual) Examination of the ligament
Other: Negative Group (Rupture and Gap sign are both negative); Rupture and Gap sign are both negative	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.; Other Names: Open (visual) Examination of the ligament

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Goztepe Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Anticipated): August 4, 2023
• Study Completion (Anticipated): December 4, 2023

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Rupture; Ankle Fractures
• Other Study ID Numbers: 2021-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No