Suspended

Gait in Syndesmosis Injuries with Screw vs Suture Button Fixation

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Study Aim

This study aims to evaluate how screw fixation compares to suture button fixation in improving walking patterns for individuals with syndesmosis injuries.

What is being tested

Suture Button vs Screw Fixation

Device
Who is being recruted

Over 19 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2021
See protocol details

Summary

Principal SponsorUniversity of Nebraska
Last updated: January 28, 2026
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Study start date: October 1, 2021

Actual date on which the first participant was enrolled.

This study focuses on patients with certain types of ankle injuries, specifically those where the joint becomes unstable. The aim is to compare two common surgical methods used to fix these injuries: screw fixation and suture button fixation. The study is important as it seeks to determine which method leads to better recovery and movement after surgery, potentially improving treatment for people with these injuries. By understanding the differences in recovery and walking patterns, doctors may be able to choose the best treatment method for future patients. Participants in the study will undergo one of the two surgical treatments for their ankle injury. After the surgery, their recovery will be closely monitored for a year. Researchers will measure how well participants are able to walk, using a special mat that tracks various aspects of their steps, like speed, step length, and time spent with both feet on the ground. This involves walking a set distance multiple times and averaging the results. These measurements will help determine which surgical method allows for better walking patterns and faster recovery.

Official TitleComparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button
NCT04972578
Principal SponsorUniversity of Nebraska
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * 19 years of age and older * Isolated rotational ankle injury * Syndesmotic instability (determined either pre- or intra-operatively) * Length-stable fibula fracture pattern Exclusion Criteria: * Open fracture * Length-unstable fracture pattern (including Maisonneuve fracture pattern) * Syndesmotic stability (determined either pre- or intra-operatively) * Lower extremity neuropathy * History of prior trauma or surgery to injured ankle * Non-ambulatory * Use of ambulatory assistive device prior to injury

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Traditional fixation method of placing one or two screws across the syndesmosis.

Group II

Active Comparator
Suture button implants which use a suture and anchor to repair the syndesmosis

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Nebraska Medicine, Bellevue Health Center

Bellevue, United StatesOpen Nebraska Medicine, Bellevue Health Center in Google Maps
Suspended

Lauritzen Outpatient Center

Omaha, United States
Suspended

Village Point Outpatient Center

Omaha, United States
Suspended3 Study Centers