NCT05538845

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

4 years

First QC Date

August 25, 2022

Last Update Submit

September 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Screw

Screw fixation

Device: Screw fixation

Suture button

Suture button

Device: Suture button

Interventions

Screw fixation to patients

Screw

Suture button for patients

Suture button

Eligibility Criteria

Age19 Years - 91 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Comparison of 110 patients with screw or suture button method.

You may qualify if:

  • 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

You may not qualify if:

  • Patients younger than 18 years of age
  • Conservative treatment
  • Pathological and neglected fractures
  • Patient's non-compliance with follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University School of Medicine

Erzurum, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 35982324BACKGROUND
  • 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 Nov-Dec;45(6):e321-e325. doi: 10.3928/01477447-20220805-01. Epub 2022 Aug 10.

    PMID: 35947455BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

August 25, 2022

First Posted

September 14, 2022

Study Start

November 1, 2017

Primary Completion

November 1, 2021

Study Completion

July 1, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations