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A New Method for Deltoid Ruptures: Gap Sign

Primary Purpose

Ankle Fractures, Ligament Rupture, Ligament Injury

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Deltoid Gap Sign
Sponsored by
Goztepe Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ankle Fractures

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • İstanbul Medeniyet University.Göztepe State HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Positive Group (Rupture and Gap Sign are both positive)

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

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

Negative Group (Rupture and Gap sign are both negative)

Arm Description

Rupture and Gap Sign are both positive

Rupture positive but Gap Sign is negative

No rupture exists but Gap Sign is positive

Rupture and Gap sign are both negative

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 30, 2021
Last Updated
March 6, 2023
Sponsor
Goztepe Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05188391
Brief Title
A New Method for Deltoid Ruptures: Gap Sign
Official Title
A Novel Examination Method for Deltoid Injuries: Deltoid Gap Sign
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
August 4, 2023 (Anticipated)
Study Completion Date
December 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goztepe Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures, Ligament Rupture, Ligament Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Physicians who will perform the examination will not know other physicians' decisions.
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Positive Group (Rupture and Gap Sign are both positive)
Arm Type
Other
Arm Description
Rupture and Gap Sign are both positive
Arm Title
Rupture Positive Group (Rupture positive but Gap Sign is negative)
Arm Type
Other
Arm Description
Rupture positive but Gap Sign is negative
Arm Title
Gap Sign Positive Group (No rupture exists but Gap Sign is positive)
Arm Type
Other
Arm Description
No rupture exists but Gap Sign is positive
Arm Title
Negative Group (Rupture and Gap sign are both negative)
Arm Type
Other
Arm Description
Rupture and Gap sign are both negative
Intervention Type
Diagnostic Test
Intervention Name(s)
Deltoid Gap Sign
Other Intervention Name(s)
Open (visual) Examination of the ligament
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity of the Gap Sign
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Specificity of the Gap Sign
Description
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.
Time Frame
24 hours
Title
Likelihood ratios of the Gap Sign
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esat UYGUR
Phone
+905556916122
Email
esatuygur@gmail.com
Facility Information:
Facility Name
İstanbul Medeniyet University.Göztepe State Hospital
City
İstanbul
State/Province
Kadıkoy
ZIP/Postal Code
34732
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esat UYGUR
Phone
05556916122
Email
esatuygur@gmail.com
First Name & Middle Initial & Last Name & Degree
Esat UYGUR
Phone
+905556916122
Email
esatuygur@gmail.com
First Name & Middle Initial & Last Name & Degree
Oğuzhan Özyaman, Resident

12. IPD Sharing Statement

Plan to Share IPD
No

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A New Method for Deltoid Ruptures: Gap Sign

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