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New ankle implant aims to get patients walking weeks sooner

NCT ID NCT06085586

Disease control Sponsor: Maimonides Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new surgical implant called Fibulink for repairing ankle fractures with torn ligaments. The goal is to see if it allows patients to start walking fully at 4 weeks instead of the usual 6 weeks, without the implant failing. 56 adults with specific ankle injuries will be enrolled and followed for 6 months to check if the ankle stays properly aligned.

What this could mean

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

Active substance
Fibulink Syndesmosis Repair System (a surgical implant)
What this could lead to
If successful, this could allow patients to walk sooner after ankle surgery, potentially speeding up recovery and reducing long-term joint damage.
What could go wrong
This is a small, early-stage study with only 56 participants. The device may not maintain ankle alignment as hoped, and earlier weight bearing could increase the risk of implant failure or re-injury.

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 56 people

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

Started

Jul 2023

Expected to finish

Dec 2026

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

22 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: * ankle fracture with syndesmotic disruption as assessed with intra-operative cotton test. This includes the following injuries: * Syndesmotic sprain (without fractures) * Bimalleolar equivalent ankle fractures * Bimalleolar ankle fractures * Maisonneuve fractures * Trimalleolar ankle fractures without the need for posterior malleolus fixation * Ankle fracture dislocations Exclusion Criteria: * 1\) previous ankle surgery, 2) active local infection about the ankle, 3) chronic ankle deformity secondary to trauma or congenital, 4) ligamentous laxity, 5) pathologic fractures, 6) peripheral vascular disease, 7) peripheral neuropathy, 8) diabetes neuropathy and charcot, 9) open fractures, 10) poly trauma, 11) inability to provide informed consent, 12) symptomatic ankle osteoarthritis, 12) retained hardware, 13) pregnant, 14) metabolic bone disease, 15) history of chronic steroid use, 16) mal-reduced ankle fractures

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Conditions

The condition(s) this trial relates to.

Ankle Fractures ankle injury Fibula Fractures

As listed by the trial registrant

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

Ankle dislocation Ankle fractures Bimalleolar equivalent fracture Bimalleolar fractures Maisonneuve fracture Syndesmotic injuries Trimalleolar 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

  • Maimonides Medical Center

    RECRUITING

    Brooklyn, New York, 11219, United States

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