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Can a brace replace the cast for certain ankle fractures?

NCT ID NCT05412693

Disease control Sponsor: Ostfold Hospital Trust 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial compares a functional brace to a traditional cast for treating a specific type of partially unstable ankle fracture (Weber B/SER4a). Adults aged 18 to 80 with these fractures are randomly assigned to wear either a brace or a cast for six weeks. The goal is to see if the brace is just as effective as the cast at reducing pain and improving foot and ankle function over two years.

What this could mean

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

Active substance
a functional orthosis (brace) compared with a traditional cast
What this could lead to
If the brace works as well as a cast, people with this type of ankle fracture could have a more comfortable and convenient treatment option.
What could go wrong
This is a relatively small trial, and the brace might not provide enough support for proper healing, leading to worse outcomes than a cast.

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

115 people

The number who actually took part.

Started

May 2022

Finished

Mar 2026

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: * Patients: * With isolated Weber type B fractures that are deemed stable on weightbearing radiographs (MCS injured ankle - MCS uninjured ankle \< 1 mm). * With concomitant gravity stress test evaluated as unstable (MCS injured ankle - MCS uninjured ankle \< 1 mm) * Presenting to one of the participating hospitals, and that are available for stability evaluation within 14 days after injury. * 18-80 years of age * With pre-injury walking ability without aids. Exclusion Criteria: * Patients: * with fracture of the medial malleolus, pre-hospital closed fracture reduction, open fracture, fracture resulting from high-energy trauma or multi-trauma or pathologic fracture. * with fracture of the posterior malleolus involving 25% or more of the joint surface or with a step of the intraarticular surface. (non-displaced fractures smaller than 25% can be included) * with neuropathies and generalized joint disease such as Rheumatoid Arthritis. * that are assumed not compliant (drug use, cognitive- and/or psychiatric disorders). * with previous history of ipsilateral ankle fracture. * with previous history of ipsilateral major ankle-/foot surgery. * who live outside one of the participating hospitals catchment areas (not available for follow-up).

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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

Contacts and locations

Locations

  • Sykehuset Innlandet, Gjøvik

    Gjøvik, Norway

  • Ålesund Hospital

    Ålesund, Norway

  • Østfold Hospital Trust

    Sarpsborg, Østfold fylke, 1714, Norway

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