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Shoulder fracture study: is surgery worth it for Middle-Aged adults?

NCT ID NCT06416618

Disease control Sponsor: Zealand University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether surgery helps adults aged 50 to 65 recover better from a displaced shoulder fracture compared to non-surgical treatment. Sixty participants will be randomly assigned to either have surgery (with a plate or nail) or receive non-surgical care. They will fill out questionnaires about shoulder function and quality of life at 6 months, 1 year, and 2 years to see which approach works best.

What this could mean

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

What this could lead to
If surgery proves better, it could become the standard treatment for this age group, improving shoulder function and quality of life after a fracture.
What could go wrong
This is a small, early-stage trial with only 60 participants, so results may not apply to everyone. Surgery also carries risks like infection or complications from anesthesia.

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 60 people

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

Started

May 2024

Expected to finish

Dec 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

50 to 65 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 aged between 50 and 65 years with a displaced PHF assessed to be constructible by the treating surgeon after a low-energy trauma will be considered for eligibility. * Patients should be cognitively capable of answering the follow-up questionnaires. Exclusion Criteria: * The patient does not understand written and spoken native language (Danish or Finnish/Swedish) * Inability to give informed consent * Fractures assessed to be unreconstructedly by the treating surgeon * Isolated tuberosity fracture, fracture dislocations, open fractures, and fractures with involvement of the articular surface * Less than 25% contact between head fragment and metaphysis/diaphysis measured at two perpendicular radiographs at two weeks. * Pathological fractures or previous fractures in the same proximal humerus * Concomitant fractures, which could influence the outcome * Paralysis in upper extremity

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Conditions

The condition(s) this trial relates to.

humerus fracture Shoulder Fractures

As listed by the trial registrant

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

Proximal humeral fracture Shoulder fractures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. 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

  • Centre for Evidence-Based Orthopaedics, Zealand University Hospital

    RECRUITING

    Køge, Region Sjælland, 4600, Denmark

  • Tampere University Hospital

    NOT_YET_RECRUITING

    Tampere, 33520, Finland

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