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Could a single bone screw save ankles from arthritis?

NCT ID NCT07755462

Disease control Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This trial compares two surgical approaches for a common type of ankle fracture. Half of the participants will have the posterior bone fragment fixed with a plate or screw, while the other half will not. The goal is to see if fixing this fragment makes the ankle joint stable enough to avoid extra hardware, which could lower the risk of future arthritis and reduce complications.

What this could mean

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

Active substance
Surgical fixation of the posterior bone fragment in ankle fractures
What this could lead to
If successful, this approach could reduce the need for extra screws or plates, potentially lowering complication rates and improving long-term ankle health.
What could go wrong
The trial is relatively small and early, and results may not apply to all fracture types. There is also a risk that fixing the fragment may not improve stability as hoped.

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 150 people

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

Started

Sep 2025

Expected to finish

Sep 2029

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 years and older

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: * Patient informed and written consent obtained * Male or female participants aged 18 years or older * Recent first-time ankle fracture (\< 3 weeks prior to inclusion) involving the posterior marginal fragment and syndesmosis (Bartoníček 2, 3, or 4) confirmed on preoperative CT scan * Fractured posterior marginal fragment with thickness \> 2 mm and height \> 6 mm in the sagittal plane on preoperative CT scan Exclusion Criteria: * Medical contraindication to surgery as assessed by the investigator based on risk-benefit evaluation * High Tscherne grade soft-tissue injury score * Recent lower-extremity surgery within the past 3 months * Recurrent ankle fracture on the same side * Patient deprived of liberty by judicial or administrative order * Patient not affiliated with or beneficiary of a national social security scheme * Patient unable to understand spoken or written French * Patient whose geographical residence is incompatible with close in-person study follow-up * Adult patient unable or unfit to give informed consent * Woman of childbearing potential not using effective contraception * Pregnant or breastfeeding woman

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Conditions

The condition(s) this trial relates to.

Ankle Fractures osteoarthritis

As listed by the trial registrant

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

Ankle fractures Osteoarthritis, ankle

Contacts and locations

Locations

  • Groupe hospitalier Diaconesses Croix Saint Simon

    Paris, Paris, 75020, France

More trials for these conditions

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