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Hand fracture study questions need for surgery: early motion may be just as good

NCT ID NCT07357493

Disease control Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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)

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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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether people with displaced hand fractures can avoid surgery and instead use early, unrestricted movement and rehabilitation. 552 adults with a single displaced spiral or oblique fracture of the index to pinky finger bones will be randomly assigned to either surgery or non-operative care. The main goal is to compare hand grip strength one year after injury.

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 this trial succeeds, it could show that many people with displaced hand fractures can skip surgery and recover just as well with early movement and rehabilitation.
What could go wrong
This is a non-inferiority trial, meaning it aims to prove non-surgery is not worse than surgery. The results may not apply to all fracture types, and there is always a risk of complications like poor healing or deformity in either group.

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 552 people

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

Started

Mar 2026

Expected to finish

Mar 2031

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: * Age ≥18 years. * Access to a valid e-mail. * Injury within 10 days prior to inclusion. * Normal bilateral hand function prior to injury. * Ability and willingness to provide written informed consent * Single, displaced spiral or oblique diaphyseal fracture of the second to fifth metacarpals with definition of diaphysis as described by AO 2018 (AO/OTA as 77.2-5.2A) (Meinberg et al., 2018). * Fracture line length at least twice the diameter of the bone at the level of the fracture. * Fractures with at least 2 mm of radiological displacement and/or malrotation of injured finger compared to uninjured side regardless of fracture displacement. Exclusion Criteria: * The patient IS NOT expected to have difficulty adhering to the study protocol (e.g., due to insufficient language proficiency, dementia, substance abuse, or other reasons). * The patient DOES NOT have an open fracture (Gustilo-Anderson grade \> I) or a pathological fracture. * The patient DOES NOT have an ipsilateral fracture of the upper extremity, polytrauma, or generalized joint dysfunction (e.g., rheumatoid arthritis).

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As listed by the trial registrant

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

Metacarpal shaft fractures

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Karolinska Institutet, Danderyd's hospital

    RECRUITING

    Stockholm, Stockholm County, 18288, Sweden

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