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New data on XtraFix® frame for broken bones

NCT ID NCT05943574

Disease control Sponsor: Zimmer Biomet 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 91 people who had a metal frame (XtraFix®) placed outside their body to hold broken wrist or shoulder bones in place. The goal was to see if the frame helps bones heal safely and works as intended. Researchers checked X-rays and tracked any problems, like infections or device issues, for at least a year after surgery.

What this could mean

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

Active substance
XtraFix® Small External Fixation System (a metal frame placed outside the body to stabilize broken bones)
What this could lead to
If successful, this study confirms that the XtraFix® system is a safe and effective option for stabilizing certain wrist and shoulder fractures.
What could go wrong
This is a small, completed study without a comparison group, so results may not apply to all patients. Complications like infection or pin loosening are possible.

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

91 people

The number who actually took part.

Started

Jun 2024

Finished

Nov 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

Consecutive series of cases implanted with the XtraFix® Small External Fixation System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.

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: * 18-year-old or older patients having received the XtraFix® Small External Fixation System for the treatment of long bone fractures. * Specifically, the system is intended for temporary stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated. * Revision surgeries will also be included in the study. * In this study we will only collect data on wrist and proximal humerus fractures. Exclusion Criteria: * Off-label use * Active or suspected infection * Conditions that limit the patient's ability and/or willingness to follow instructions during the healing process * Inadequate skin, bone, or neurovascular status

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Conditions

The condition(s) this trial relates to.

humerus fracture radius fracture Wrist Fractures

As listed by the trial registrant

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

Proximal humerus fracture Wrist fracture

Contacts and locations

Locations

  • Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"

    Naples, Campania, 80131, Italy

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