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New surgical approach aims to improve ankle fracture recovery

NCT ID NCT07831265

NEW Symptom relief Sponsor: Fuzhou University Affiliated Provincial Hospital 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers compare two surgical methods for complex ankle fractures that also involve a tear of the ligament connecting the two lower leg bones. Adults aged 18 to 55 with these injuries receive either dynamic fixation or standard screw fixation. The trial tracks ankle function and healing over 12 months to see which method works better.

What this could mean

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

Active substance
dynamic internal fixation device for ankle fractures
What this could lead to
If dynamic fixation works better, it could become a preferred surgical option that helps people with complex ankle fractures regain mobility with fewer complications.
What could go wrong
This is a single-center study of 100 people, so results may not apply broadly. Surgery carries risks like infection, nerve injury, and hardware problems, and dynamic fixation may not outperform standard screws.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

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

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Age 18-55 years; 2. Radiologically confirmed complex ankle fracture combined with distal tibiofibular syndesmosis separation; 3. First-time surgical treatment of the ankle; 4. Time from injury to surgery ≤ 2 weeks; 5. Able to comply with follow-up and sign a written informed consent; 6. Ankle function was basically normal before injury. Exclusion Criteria: 1\. Age \<18 or \>55; 2. Pathological fracture; 3. Previous ankle surgery or serious primary ankle disease; 4. Time from injury to surgery \>2 weeks; 5. Active infection or serious medical condition; 6. Severe neurological or psychiatric disorder affecting follow-up compliance; 7. Postmenopausal women; 8. Other situations not suitable for enrollment

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Conditions

The condition(s) this trial relates to.

Ankle Fractures ankle injury

As listed by the trial registrant

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

Ankle fractures Syndesmotic injury of the ankle

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.