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

Stopped early · Not applicable

Conditions studied: Acute Disruption of Ankle Syndesmosis

In brief

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.

Key facts

Study ID

NCT04972578

Run by

University of Nebraska

People needed

21

Starts

2021-10-01

Expected to finish

2026-01-09

Last updated by the study team

2026-01-13

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 19 years of age and older
• Isolated rotational ankle injury
• Syndesmotic instability (determined either pre- or intra-operatively)
• Length-stable fibula fracture pattern

You may not qualify if…

• 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

Where it is running

• Nebraska Medicine, Bellevue Health Center — Bellevue, Nebraska, United States
• Lauritzen Outpatient Center — Omaha, Nebraska, United States
• Village Point Outpatient Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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