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New clavicle plate system tested for safety and healing

NCT ID NCT05327959

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at a commercially available metal plate and screw system used to fix broken collarbones. About 98 adults who need surgery for a clavicle fracture will be followed for 12 months to see if the bone heals properly and to track any side effects. The goal is to confirm the system is safe and works well.

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

98 people

The number who actually took part.

Started

May 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patient must be 18 years of age or older. * Patient must have a clavicle fracture requiring surgical intervention and be eligible for fixation by locking plate and screws. * Unilateral or Bilateral fractures. * Patient must be capable of understanding the doctor's explanation, following doctor's instruction, is able to and willing to complete the protocol required follow-up. * Patient must have a signed IRB/EC approved informed consent. Exclusion Criteria: * Active infection. * Patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone. * Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent, following postoperative care instructions. * Foreign body sensitivity where material sensitivity is suspected, testing is to be completed prior to implantation of the device. * Patient is a current alcohol or drug abuser * Patient is a prisoner * Patient known to be pregnant or breast feeding * Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study) * Not expected to survive the duration of the follow-up program

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As listed by the trial registrant

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

Clavicle fracture Clavicle injury

Contacts and locations

Locations

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • General Foundation of the University of Valladolid

    Valladolid, 47002, Spain

  • Slocum Research & Education Foundation

    Eugene, Oregon, 97401, United States

  • University of Michigan - Michigan Medicine

    Ann Arbor, Michigan, 48137, United States

  • University of Texas San Antonio

    San Antonio, Texas, 78229, United States

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