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Arm fracture Face-Off: plate vs. brace

NCT ID NCT01719887

Disease control Sponsor: Töölö Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 01, 2026 · Last updated Oct 02, 2026 · Updated 1 time

Summary

This trial compares two ways to treat a broken upper arm bone (humeral shaft fracture): surgery with a metal plate and screws, or a functional brace. Adults with a single fracture are randomly assigned to one treatment. Both groups receive physiotherapy. Researchers track arm function, pain, complications, and cost over 10 years to see which approach works better.

What this could mean

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

Active substance
surgical repair with a locking plate versus a functional brace
What this could lead to
If surgery works better, it could become the standard treatment for upper arm fractures, helping people regain arm function faster and with fewer complications.
What could go wrong
Surgery carries risks like infection, nerve damage, and the need for another operation. Bracing can also fail to heal the bone properly. This is a small trial, so results may not apply to everyone.

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

82 people

The number who actually took part.

Started

Nov 2012

Expected to finish

Jan 2028

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: * Over 18 years old patient who agrees to the consent to participation in this study * Unilateral dislocated humeral shaft fracture (dislocation over thickness of the bone cortex, fracture below the level of insertion of pectoralis major muscle and 5 cm above the olecranon fossa) * Randomization can be done within 10 days and operation within 14 days after the initial trauma * Patient is willing to participate all follow-up visits Exclusion Criteria: * Bilateral humeral shaft fracture * A significant concomitant trauma of the same upper extremity that warrants operative treatment (fracture, tendon injury, soft tissue trauma) * Other fracture or abdominal/thoracal trauma that warrants operative treatment * Open fracture * Pathological fracture * Multi-trauma patient * Vascular injury * Plexus injury * Previous trauma in the same upper extremity that causes functional deficit * Trauma or condition that warrants use of walking aid (crutches, wheelchair etc) * Disease that affects significantly general condition of the patient * Significantly impaired ability to co-operate for any reason (substance abuse, mental disorder, dementia) * Unwilling to accept both treatment methods

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Conditions

The condition(s) this trial relates to.

bone fracture humerus fracture

As listed by the trial registrant

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

Fracture

Contacts and locations

Locations

  • Tampere University Hospital

    Tampere, Finland

  • Töölö Hospital, Helsinki University Central Hospital

    Helsinki, Finland

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