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Dissolving screws could spare ankle fracture patients a second surgery

NCT ID NCT07693933

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

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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.
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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 Results may not be published yet.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)
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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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 28, 2026 · Updated 5 times

Summary

This study tests a new type of screw made from a magnesium alloy that slowly dissolves in the body over two to three years. Unlike standard metal screws, these biodegradable screws may not need to be removed in a second surgery. The trial enrolls adults aged 18 to 80 with unstable ankle fractures and follows them for 12 months to measure ankle function, healing, and safety.

What this could mean

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

Active substance
RemeOs magnesium-based biodegradable screw
What this could lead to
If successful, these screws could eliminate the need for a second surgery to remove metal hardware, reducing complications and recovery time.
What could go wrong
This is a small, early study with only 28 participants. The screws may not hold the bone as well as metal, or could cause unexpected reactions as they dissolve.

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 28 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 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 to 80 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: * Age 18-80 years * Unstable closed ankle fracture requiring surgical fixation, including unimalleolar, bimalleolar, bimalleolar-equivalent, or trimalleolar fractures * Fractures may be with or without syndesmotic instability * Willingness to follow postoperative visits and rehabilitation protocols * Ability to complete patient-reported outcome measures (PROMs) Exclusion Criteria: * Body mass index (BMI) \> 40 * Open fractures * Pathologic fractures * Active infection at the surgical site * Known allergy or hypersensitivity to magnesium or implant components * Severe peripheral vascular disease * Uncontrolled diabetes mellitus * Prior ankle surgery on the affected limb * Concomitant osteochondral lesions requiring treatment * Neuromuscular disorders affecting the lower extremity * Worker's compensation cases * Pregnancy * Non-adherence concerns or inability to comply with follow-up requirements

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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

How to take part

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  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

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Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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