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New nail tested for kids with brittle bones

NCT ID NCT05612139

Disease control Sponsor: Orthofix s.r.l. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a special telescopic nail (JuniOrtho) works and how safe it is in children with osteogenesis imperfecta (brittle bone disease). Fourteen children aged 18 months to 18 years who needed surgery for broken bones or bone straightening took part. The main goal was to see how many patients had side effects related to the nail.

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.

Participants

14 people

The number who actually took part.

Started

Aug 2024

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric patients older than 18 months suffering from osteogenesis imperfecta.

Ages

18 months to 18 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: * is in pediatric age (\> 18 month and \< 18 years) at the time of surgery; * is skeletally immature; * has a diagnosis for OI; * has a regular indication for surgical intervention with JTIN to treat femoral and/or tibial fractures, osteotomies, malunions and non-unions; * patient and/or legal representative is duly informed and doesn't oppose to participation. Exclusion Criteria: * has a medical condition that is a contraindication according to the manufacturer's instruction for use; * has any conditions that in the Investigator's opinion may interfere with the study execution or due to which the patient should not participate for safety reasons; * requires the application of, or has already in-situ the application of concomitant devices that cannot be safely removed (except for permitted concomitant devices paragraph); * is participating in other clinical trials or has taken part in any clinical study in the last 3 months with exception of analytical trials on genetics study related to OI (i.e. studies that do not include an investigational treatment for the patient such as new drugs or other medical devices); * is likely to be lost to follow up, according to investigator's opinion.

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Conditions

The condition(s) this trial relates to.

osteogenesis imperfecta Rare Diseases

As listed by the trial registrant

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

Osteogenesis imperfecta

Contacts and locations

Locations

  • Necker-Enfants Malades Hospital

    Paris, Île-de-France Region, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.