Ankle InjuriesNCT05538845
Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries
An observational study of Ankle Injuries and Syndesmotic Injuries, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
In this study, syndesmosis injuries were detected in 143 of the patients who came to Atatürk University Faculty of Medicine, Orthopedics and Traumatology clinic from October 2017 to October 2021 with ankle fractures. 33 of these patients couldn't followed for various reasons. Read more about this study
- Who is it for?
- Ages 19 to 91 years
- Conditions the study is for
- Ankle Injuries, Syndesmotic Injuries, Tibiofibular; Dislocation Distal
- What is being tested?
- Screw fixation and Suture button
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 Jul 2022
- Phase
- Observational
- 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 19 to 91 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Comparison of 110 patients with screw or suture button method.
Who may be able to join
- Ankle fractures associated with syndesmotic injury
- Age group 19-91 years
- Dislocation or non-dislocation ankle fractures
- Fractures due to acute injury (less than 3 weeks)
- Patient compliance with follow-up
Who cannot join
- Patients younger than 18 years of age
- Conservative treatment
- Pathological and neglected fractures
- Patient's non-compliance with follow-up
Trial locations and contacts
1 site in 1 country.
About this study
In this study, syndesmosis injuries were detected in 143 of the patients who came to Atatürk University Faculty of Medicine, Orthopedics and Traumatology clinic from October 2017 to October 2021 with ankle fractures. 33 of these patients couldn't followed for various reasons. Screw or suture buttone method was applied on 110 patients. And patients were examined with lots of data to compare their results. A retrospective study was conducted.
- Being tested
- Screw fixation, Suture button
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screw fixationDevice
Screw fixation to patients
Suture buttonDevice
Suture button for patients
| Study group | Role | What they receive |
|---|---|---|
| Screw | Screw fixation Receives: Device: Screw fixation | |
| Suture button | Suture button Receives: Device: Suture button |
What is being measured
The primary outcome is the main question the study is designed to answer.
angles of the joint range of motion
Calculate joint range of motion by measuring the angles between the beginning position and the ending position of available motion with goniometer
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Nov 2017
- Primary completion1 Nov 2021
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Sait Durak, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538845
- Sponsor's protocol ID
- atauni orthopedia ankle
- Status last verified
- Sep 2022
- First submitted
- 25 Aug 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hennings R, Fuchs C, Spiegl UJ, Theopold J, Souleiman F, Kleber C, Ahrberg AB. "Flexible nature of fixation" in syndesmotic stabilization of the inferior tibiofibular joint affects the radiological reduction outcome. Int Orthop. 2022 Nov;46(11):2649-2657. doi: 10.1007/s00264-022-05550-7. Epub 2022 Aug 19.
PubMed 35982324Hakverdiyev Y, McFarland EG, Kaymakoglu M, Ozdemir E, Akpinar S, Huri P, Costouros JG, Huri G. Biomechanical Strength of Screw Versus Suture Button Fixation in the Latarjet Procedure: A Cadaver Study. Orthopedics. 2022 Nov-Dec;45(6):e321-e325. doi: 10.3928/01477447-20220805-01. Epub 2022 Aug 10.
PubMed 35947455
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries
- ClinicalTrials.gov ID
- NCT05538845
- Acronym / sponsor ID
- atauni orthopedia ankle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 14 Sep 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.
In this study, syndesmosis injuries were detected in 143 of the patients who came to Atatürk University Faculty of Medicine, Orthopedics and Traumatology clinic from October 2017 to October 2021 with ankle fractures. 33 of these patients couldn't followed for various reasons. Screw or suture buttone method was applied on 110 patients. And patients were examined with lots of data to compare their results. A retrospective study was conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screw | – | Device: Screw fixationScrew fixation |
| Suture button | – | Device: Suture buttonSuture button |
Who may qualify
- Ages
- 19 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Comparison of 110 patients with screw or suture button method.
Key inclusion criteria (5 listed)
- Ankle fractures associated with syndesmotic injury
- Age group 19-91 years
- Dislocation or non-dislocation ankle fractures
- Fractures due to acute injury (less than 3 weeks)
- Patient compliance with follow-up
Key exclusion criteria (4 listed)
- Patients younger than 18 years of age
- Conservative treatment
- Pathological and neglected fractures
- Patient's non-compliance with follow-up
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 |
|---|---|---|
| Screw fixationScrew fixation to patients | Device | Screw |
| Suture buttonSuture button for patients | Device | Suture button |
Primary outcome
angles of the joint range of motion
Time frame: 12 months after surgery
Calculate joint range of motion by measuring the angles between the beginning position and the ending position of available motion with goniometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Background: PubMed 35982324Hennings R, Fuchs C, Spiegl UJ, Theopold J, Souleiman F, Kleber C, Ahrberg AB. "Flexible nature of fixation" in syndesmotic stabilization of the inferior tibiofibular joint affects the radiological reduction outcome. Int Orthop. 2022 Nov;46(11):2649-2657. doi: 10.1007/s00264-022-05550-7. Epub 2022 Aug 19.
- Background: PubMed 35947455Hakverdiyev Y, McFarland EG, Kaymakoglu M, Ozdemir E, Akpinar S, Huri P, Costouros JG, Huri G. Biomechanical Strength of Screw Versus Suture Button Fixation in the Latarjet Procedure: A Cadaver Study. Orthopedics. 2022 Nov-Dec;45(6):e321-e325. doi: 10.3928/01477447-20220805-01. Epub 2022 Aug 10.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries and Syndesmotic Injuries, run by Ataturk University 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 14 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
angles of the joint range of motion (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05538845, which also lists 2 linked publications.
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 14 Sep 2022.