Gait in Syndesmosis Injuries with Screw vs Suture Button Fixation
This study aims to evaluate how screw fixation compares to suture button fixation in improving walking patterns for individuals with syndesmosis injuries.
Suture Button vs Screw Fixation
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.21 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy 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
Nebraska Medicine, Bellevue Health Center
Bellevue, United StatesOpen Nebraska Medicine, Bellevue Health Center in Google MapsLauritzen Outpatient Center
Omaha, United StatesVillage Point Outpatient Center
Omaha, United States