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Search / Trial NCT04972578

Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button

Launched by UNIVERSITY OF NEBRASKA · Jul 12, 2021

Trial Information

Current as of July 12, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to treat a specific ankle injury called syndesmosis injury, which often happens during ankle fractures. The researchers want to compare the outcomes of two treatment methods: screw fixation and suture button fixation. Both methods are commonly used, but there's some debate about which one may be better for helping patients recover and walk normally after the injury. The trial aims to gather more evidence on how these treatments affect patients' ability to walk and their overall recovery.

To participate in the trial, you need to be an adult aged 19 or older with a certain type of ankle injury that involves syndesmotic instability, which means the joint is not stable. However, if you have had an open fracture, certain complex fracture patterns, or other specific conditions affecting your ankle, you would not be eligible. If you join the trial, you can expect to receive one of the two treatments and be monitored to see how well you recover and regain your walking ability. This research is important because it could help determine the best way to treat these injuries in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults 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 patient
  • Baseline use of ambulatory assistive device prior to injury

About University Of Nebraska

The University of Nebraska is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. With a strong commitment to improving patient outcomes and fostering scientific discovery, the university collaborates with various healthcare professionals and researchers to conduct rigorous clinical studies across diverse medical fields. The institution prioritizes ethical standards and patient safety while striving to translate research findings into practical solutions that enhance medical practices and contribute to the overall well-being of the community.

Locations

Bellevue, Nebraska, United States

Omaha, Nebraska, United States

Bellevue, Nebraska, United States

Omaha, Nebraska, United States

Patients applied

0 patients applied

Trial Officials

Sarah M Putnam, MD

Principal Investigator

University of Nebraska

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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