TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Injuries to the distal tibiofibular syndesmosis are common and occur in an estimated 25% of all rotational ankle fractures. Anatomic reduction of the syndesmosis has been associated with improved functional outcome as well as decreased rates of posttraumatic arthritis. Both screw fixation and suture fixation have become accepted standards of care for treatment of syndesmotic injuries. Recent literature would suggest trends favoring suture fixation over screw fixation with improved quality of syndesmotic reduction, postoperative range of motion, and improved maintenance of syndesmotic reduction. However, the evidence remains heterogeneous, and patient reported outcomes have failed to show a superiority of one method over the other. Additionally, there have been no studies that demonstrate objective gait outcomes comparing screw versus suture fixation for syndesmotic injuries.

Official Title

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

Quick Facts

Study Start:2021-10-01
Study Completion:2026-01-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04972578

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 19 years of age and older
  2. * Isolated rotational ankle injury
  3. * Syndesmotic instability (determined either pre- or intra-operatively)
  4. * Length-stable fibula fracture pattern
  1. * Open fracture
  2. * Length-unstable fracture pattern (including Maisonneuve fracture pattern)
  3. * Syndesmotic stability (determined either pre- or intra-operatively)
  4. * Lower extremity neuropathy
  5. * History of prior trauma or surgery to injured ankle
  6. * Non-ambulatory
  7. * Use of ambulatory assistive device prior to injury

Contacts and Locations

Principal Investigator

Sarah M Putnam, MD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

Nebraska Medicine, Bellevue Health Center
Bellevue, Nebraska, 68123
United States
Lauritzen Outpatient Center
Omaha, Nebraska, 68105
United States
Village Point Outpatient Center
Omaha, Nebraska, 68118
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Sarah M Putnam, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-01
Study Completion Date2026-01-09

Study Record Updates

Study Start Date2021-10-01
Study Completion Date2026-01-09

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Disruption of Ankle Syndesmosis