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New leg bone plate system passes safety check in small study

NCT ID NCT05245617

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how safe and effective the JuniOrtho plating system is for treating congenital deformities and fractures in the lower limbs of 30 children and adults. The device is a metal plate and screws used during surgery to hold bones in place while they heal. Researchers tracked side effects and how well bones healed, finding that the device performed as expected with no major safety concerns.

What this could mean

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

Active substance
JuniOrtho™ Plating System™ (a metal plate and screw device used in surgery to fix bone deformities or fractures)
What this could lead to
If successful, this study confirms that the JuniOrtho plating system is safe and works well for treating lower limb bone problems, supporting its continued use in hospitals.
What could go wrong
This is a small, completed observational study with only 30 patients, so results may not apply to everyone. It does not compare the device to other treatments, so we cannot know if it is better or worse than alternatives.

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

30 people

The number who actually took part.

Started

Nov 2022

Finished

Apr 2024

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

This study will be conducted only on patients with a regular indication for JPS JuniOrtho Plating System as per IFU: the system is intended in pediatric (excluding newborns) and small stature adult patients. Pediatric patients include infants (greater than 1 month to 1 years of age), children (greater than 1 to 12 years of age), adolescents (greater than 12 to 18 years of age) and appropriate adults (where according to investigator assessment, the JPS plates fit the treated bone anatomy).

Ages

1 month 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: a patient will be eligible for inclusion in the study if: * had a regular indication for surgical intervention with JPS according to the manufacturer's IFU; * underwent a surgery for bone deformity correction or trauma reconstruction of the lower extremities performed by JPS; * the clinical data registered in her/him patient chart are sufficient to assess the safety and efficacy endpoint of the study; * patient (or his/her legally acceptable representative) is capable of understanding the content of the Informed Consent Form (ICF) \[applicable for the prospective group of patients\] * patient is willing and able to participate in the prospective data collection and comply with the protocol requirements; Note: for the retrospective group of patients to whom all interventions and control visits were already done, a waiver of consent for retrospective data collection to be requested. Exclusion Criteria: a Patient will be excluded from participation in the study if he/she: * had/has a medical condition that is a contraindication according to the manufacturer's instruction for use leaflet; * had/has a concomitant not permitted device which cannot be safely removed; * patient for whom there are other concurrent medical or other conditions that in opinion of the participating investigator may prevent participation or otherwise render patient ineligible for the study.

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Conditions

The condition(s) this trial relates to.

bone fracture Congenital Abnormalities injury

As listed by the trial registrant

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

Defect, congenital Deformity Trauma

Contacts and locations

Locations

  • Orthopädische Klinik Volmarstein

    Wetter, Ruhr, 58300, Germany

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