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New dissolving nails could spare kids a second surgery for broken arms

NCT ID NCT07536581

Symptom relief Sponsor: Children's Fractures Interest Group, Denmark 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether special dissolving nails can heal children's broken forearm bones as well as standard titanium nails. The dissolving nails go away on their own, so many kids might not need a second operation to remove them. About 60 children who need surgery for a displaced forearm fracture will be randomly assigned to get either dissolving or titanium nails. The main goal is to see if the bones heal at the same speed, while also checking for complications and recovery.

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.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

3 to 13 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: * Diagnosis of a traumatic diaphyseal forearm fracture of the radius, ulna, or both * Operative fixation required * Fractures must be complete (not unicortical or greenstick) AND displaced \>50% of bone width (after attempted closed reduction) AND/OR angulated \>10° in any plane (after attempted closed reduction) * Informed consent obtained Exclusion Criteria: * Conditions where internal fixation is contraindicated (e.g. active or potential infection) * Grossly open fractures (Gustilo Anderson grade \> 2) * Fracture occurred more than 2 weeks prior * Fractures that are well managed conservatively (undisplaced or minimally displaced) * Previous ipsilateral forearm fracture (risk of closed medullary canal) * Fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal) * Concurrent ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants) * Unable to participate in follow-up * Existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease) * Participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the PI the results of the present study Intraoperative exclusion criteria: * Fractures suitable for closed reduction and casting (see 6.3.9) * Indication for treatment 1 (BIN) only * Indication for treatment 2 (ESIN) only * Intraoperative decision to use implants other than the devices under investigation

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Conditions

The condition(s) this trial relates to.

bone fracture Forearm Injuries primary interstitial lung disease specific to childhood radius fracture ulna fracture

As listed by the trial registrant

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

Adolescent Child Forearm injuries Fracture fixation, intramedullary Fracture healing Fractures, bone Internal fixation Orthopedic operations Polymers Radiography Radius fractures Randomized controlled trial (RCT) Ulna 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

  • Copenhagen University Hospital - Herlev

    København NV, 2400, Denmark

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