A New Method for Deltoid Ruptures: Gap Sign

NCT05188391 | Unknown

• 1 other identifier: 2021-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures; Ligament Rupture; Ligament Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Specificity of the Gap Sign

  24 hours

• Likelihood ratios of the Gap Sign

  24 hours

Study Arms (4)

Positive Group (Rupture and Gap Sign are both positive)

OTHER

Rupture and Gap Sign are both positive

Diagnostic Test: Deltoid Gap Sign

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

OTHER

Rupture positive but Gap Sign is negative

Diagnostic Test: Deltoid Gap Sign

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

OTHER

No rupture exists but Gap Sign is positive

Diagnostic Test: Deltoid Gap Sign

Negative Group (Rupture and Gap sign are both negative)

OTHER

Rupture and Gap sign are both negative

Diagnostic Test: Deltoid Gap Sign

Interventions

Deltoid Gap Sign DIAGNOSTIC_TEST

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.

Also known as: Open (visual) Examination of the ligament

Gap Sign Positive Group (No rupture exists but Gap Sign is positive); Negative Group (Rupture and Gap sign are both negative); Positive Group (Rupture and Gap Sign are both positive); Rupture Positive Group (Rupture positive but Gap Sign is negative)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medial malleolus fractures
• Talus fractures
• Patients in pediatric age

Sponsors & Collaborators

• Goztepe Training and Research Hospital: lead

Study Sites (1)

İstanbul Medeniyet University.Göztepe State Hospital

Istanbul, Kadıkoy, 34732, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Central Study Contacts

Esat UYGUR

CONTACT

+905556916122; esatuygur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physicians who will perform the examination will not know other physicians' decisions.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.M.D.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 12, 2022
• Study Start: August 4, 2021
• Primary Completion: August 4, 2023
• Study Completion: December 4, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)