Ankle FracturesNCT05188391
A New Method for Deltoid Ruptures: Gap Sign
A study testing Deltoid Gap Sign in people with Ankle Fractures and Ligament Rupture, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankle Fractures, Ligament Rupture, Ligament Injury
- What is being tested?
- Deltoid Gap Sign
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2021to 4 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medial malleolus fractures
- Talus fractures
- Patients in pediatric age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Medeniyet University.Göztepe State Hospital
Istanbul, Kadıkoy, 34732
Esat UYGUR, 05556916122, esatuygur@gmail.com
Esat UYGUR, +905556916122, esatuygur@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Fractures, Ligament Rupture, Ligament Injury
- Being tested
- Deltoid Gap Sign
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deltoid Gap SignDiagnostic test
Also called Open (visual) Examination of the ligament
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Group (Rupture and Gap Sign are both positive) | Other | Rupture and Gap Sign are both positive Receives: Diagnostic Test: Deltoid Gap Sign |
| Rupture Positive Group (Rupture positive but Gap Sign is negative) | Other | Rupture positive but Gap Sign is negative Receives: 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 Receives: Diagnostic Test: Deltoid Gap Sign |
| Negative Group (Rupture and Gap sign are both negative) | Other | Rupture and Gap sign are both negative Receives: Diagnostic Test: Deltoid Gap Sign |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start4 Aug 2021
- Primary completion4 Aug 2023 (estimated)
- Study completion4 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goztepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esat UYGUR, Goztepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188391
- Sponsor's protocol ID
- 2021-04
- Status last verified
- Mar 2023
- First submitted
- 30 Nov 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Examination Method for Deltoid Injuries: Deltoid Gap Sign
- ClinicalTrials.gov ID
- NCT05188391
- Acronym / sponsor ID
- 2021-04
- Conditions
- Ankle Fractures, Ligament Rupture, Ligament Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Goztepe Training and Research HospitalUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 4 Aug 2023 (estimated)
- Study completion
- 4 Dec 2023 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive Group (Rupture and Gap Sign are both positive) | Other | Diagnostic Test: Deltoid Gap SignRupture and Gap Sign are both positive |
| Rupture Positive Group (Rupture positive but Gap Sign is negative) | Other | Diagnostic Test: Deltoid Gap SignRupture positive but Gap Sign is negative |
| Gap Sign Positive Group (No rupture exists but Gap Sign is positive) | Other | Diagnostic Test: Deltoid Gap SignNo rupture exists but Gap Sign is positive |
| Negative Group (Rupture and Gap sign are both negative) | Other | Diagnostic Test: Deltoid Gap SignRupture and Gap sign are both negative |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Medial malleolus fractures
- Talus fractures
- Patients in pediatric age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deltoid Gap SignAlso: Open (visual) Examination of the ligamentAt 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. | Diagnostic test | 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) |
Primary outcome
Sensitivity of the Gap Sign
Time frame: 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.
2 secondary outcomes
Specificity of the Gap Sign
Time frame: 24 hours
Likelihood ratios of the Gap Sign
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deltoid Gap Sign in people with Ankle Fractures and Ligament Rupture, run by Goztepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esat UYGUR (+905556916122, esatuygur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the Gap Sign (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.