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Facial fracture fixation system passes safety check in 150 patients

NCT ID NCT07245719

Knowledge-focused Sponsor: Stryker Craniomaxillofacial 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 back at the medical records of 150 adults who had surgery for facial fractures using the Stryker Universal CMF System. The goal was to confirm that the system safely and effectively holds broken facial bones in place. Researchers checked whether any patients needed a second unplanned surgery and recorded any complications during or after the procedure.

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

150 people

The number who actually took part.

Started

Mar 2025

Finished

Mar 2026

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

Eligible patients will be identified as having had a surgical procedure involving the Subject Device.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Skeletally mature patients at the time of surgery. 2. Patients who underwent a craniomaxillofacial procedure using implants of the Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System as per routine clinical practice. 3. Patients for whom data on the primary outcome variable is available. 4. Patients with data available from follow-up visits. Exclusion Criteria: 1. Patients with active infections at the time of surgery. 2. Patients with known metal allergies and/or foreign body sensitivity at the time of surgery. 3. Subjects with non-reducible and unstable fractures (except reconstruction plates) at the time of surgery that were treated with the subject devices. 4. Patients who underwent secondary reconstructions with non-secondary reconstruction plates 5. Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery.

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Conditions

The condition(s) this trial relates to.

jaw fracture Maxillary Fractures Orbital Fractures Zygomatic Fractures

As listed by the trial registrant

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

Facial fractures Maxilla fractures Orbital fractures Zygomatic fractures

Contacts and locations

Locations

  • Weill Cornell Medicine Oral and Maxillofacial Surgery 525 East 68th Street, F-2132

    New York, New York, 10065, United States

More trials for these conditions

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