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New study seeks best surgical method for broken ankles

NCT ID NCT07481266

Symptom relief Sponsor: muhammed kılıç Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two surgical techniques for fixing certain types of ankle fractures. The goal is to see which method causes fewer wound problems and leads to better recovery. About 100 adults with specific ankle fractures will be followed for one year after surgery.

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.

Started

Feb 2024

Expected to finish

Mar 2027

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 65 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: * Patients aged between 18 and 65 years. * Diagnosis of an acute, closed, unstable rotational ankle fracture with concomitant involvement of the posterior malleolus and lateral malleolus (trimalleolar or bimalleolar equivalent fractures). * Fracture morphology explicitly indicating surgical reduction and internal fixation via a posterolateral approach (e.g., Bartonicek Type II, III, or IV). * Ability to provide informed consent and willingness to comply with the 12-month postoperative rehabilitation and follow-up protocol. Exclusion Criteria: * Open fractures, severe tibial pilon variants, or fractures with intra-articular comminution extending beyond the posterior malleolus. * Persistent Syndesmotic Instability: Patients demonstrating persistent distal tibiofibular syndesmotic instability (confirmed by intraoperative hook test) after the fixation of the posterior and lateral malleoli, which inherently requires additional trans-syndesmotic fixation (e.g., syndesmotic screws or suture-button devices). This exclusion is strictly applied to eliminate methodological bias, as the experimental single-window approach intentionally restricts direct lateral access for trans-syndesmotic interventions. * Delayed surgical intervention exceeding 7 days from the initial trauma, leading to organized hematoma or compromised soft-tissue envelopes. * Pre-existing conditions detrimental to soft-tissue healing and functional assessment, including severe peripheral arterial disease, uncontrolled diabetes mellitus with neuropathy, or severe ipsilateral ankle osteoarthritis. * Previous history of ipsilateral ankle fractures or surgeries.

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Conditions

The condition(s) this trial relates to.

Ankle Fractures

As listed by the trial registrant

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

Ankle fractures Lateral malleolus fracture Posterior malleolus fractures

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Ankara Bilkent City Hospital

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

More trials for these conditions

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