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Facial implant device under Post-Market safety review

NCT ID NCT07245810

Disease control 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study reviews the safety and performance of Stryker's Facial iD Universal Plate Configurator, a device used to fix facial fractures or during reconstructive surgery. Researchers will look at medical records of 726 patients who received the implant to see if unplanned revision surgery was needed and to track complications like infections. The goal is to confirm the device works as intended in real-world use.

What this could mean

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

Active substance
Stryker Facial iD Universal Plate Configurator (a medical implant device for facial bone fixation)
What this could lead to
If successful, this study confirms that the plate configurator is safe and works well for fixing facial fractures and reconstructions, supporting its continued use in routine surgery.
What could go wrong
This is a retrospective study, meaning it looks back at past data, not a controlled trial. It cannot prove the device is better than other options, and results may be limited by incomplete records.

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

About 726 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

May 2026

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.

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. Patients who received a Stryker UPC plate for osteotomy, stabilization and rigid fixation of maxillofacial fractures or reconstruction as per routine clinical practice 2. Patients for whom data on the primary outcome variable is available. Exclusion Criteria: 1. Patients with non-reducible and unstable fractures at the time of surgery 2. Patients with fractures of a severely atrophic mandible at the time of surgery 3. Patients with active local infections at the time of surgery 4. Patients with metal allergies and/or foreign body sensitivity at the time of surgery 5. Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery 6. Potentially non-compliant patients who are unwilling or incapable of following postoperative care instructions

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Conditions

The condition(s) this trial relates to.

jaw fracture Mandibular Fractures Maxillary Fractures

As listed by the trial registrant

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

Facial fracture Mandibular fractures Maxilla fracture Orthognathic surgical procedures

Contacts and locations

Locations

  • New York Center for Orthognathic and Maxillofacial Surgery

    New York, New York, 10022, United States

  • New York Center for Orthognathic and Maxillofacial Surgery, Lake Success, New York

    New York, New York, 11042, United States

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