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Ankle injury study compares screws and suture buttons for better walking recovery

NCT ID NCT04972578

Knowledge-focused Sponsor: University of Nebraska Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared how well people walk after ankle syndesmosis repair using either screw fixation or a suture button device. Researchers measured step length, width, timing, and speed on a special mat. The trial was terminated early and enrolled only 21 adults with isolated rotational ankle injuries. Results may help guide surgical choices but are limited due to the small size and early stop.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Screw fixation or suture button device
What this could lead to
If successful, this study could help doctors choose the best surgical method for ankle syndesmosis injuries to improve walking recovery.
What could go wrong
The study was terminated early with only 21 participants, so results are limited and may not apply to all patients. No clear superiority was shown between the two methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

21 people

The number who actually took part.

Started

Oct 2021

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute disruption of ankle syndesmosis

Contacts and locations

Locations

  • Lauritzen Outpatient Center

    Omaha, Nebraska, 68105, United States

  • Nebraska Medicine, Bellevue Health Center

    Bellevue, Nebraska, 68123, United States

  • Village Point Outpatient Center

    Omaha, Nebraska, 68118, United States