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NCT05538845 Clinical Trial

Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries

Ankle Injuries Clinical Trial

Official title:
Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05538845
Other study ID # atauni orthopedia ankle
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date July 1, 2022

Study information
Verified date September 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date July 1, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 91 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients younger than 18 years of age - Conservative treatment - Pathological and neglected fractures - Patient's non-compliance with follow-up

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Screw fixation
Screw fixation to patients
• Suture button
Suture button for patients

Locations
Country Name City State
Turkey Ataturk University School of Medicine Erzurum

Sponsors (1)
Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Hakverdiyev 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 Aug 10:1-5. doi: 10.3928/01477447-20220805-01. [Epub ahead of print] — View Citation

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 Aug 19. doi: 10.1007/s00264-022-05550-7. [Epub ahead of print] — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 12 months after surgery
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