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New jaw fixation device tracked in global registry

NCT ID NCT03405389

Knowledge-focused Sponsor: AO Innovation Translation Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This registry study tracked 44 adults with broken jaw bones who were treated using the MatrixWAVE MMF system, a device that helps align the jaw during healing. Researchers recorded how long the device took to apply, any complications, and how patients felt about speaking, eating, and kissing afterward. The goal was to gather real-world data on the system's performance, not to test a new treatment.

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

44 people

The number who actually took part.

Started

Jun 2019

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients older than 18 years old suffering with a mandibilar fracture without involvement of the condyle(s) or maxilla.

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: * Age 18 years or older at the time of the surgery * Diagnosis of a mandibular fracture requiring ORIF and use of MMF during or subsequent to surgical intervention for a minimum of two weeks * Informed consent obtained, i.e.: * Ability to understand the content of the patient information/ICF * Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP) * Signed and dated EC/IRB approved written informed consent Exclusion Criteria: * Pre-traumatic non-occlusion due to hypodontia, edentulousness or severe malalignment of dental arches (e.g. complete crossbite) * Concomitant maxillary fracture (e.g. Le Fort) * Any not medically managed severe systemic disease * Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment * Pregnancy or women planning to conceive within the registry period * Prisoner * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry * Intra-operative decision of the surgeon to use other MMF systems than the MatrixWAVE MMF system

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Conditions

The condition(s) this trial relates to.

jaw fracture Malocclusion Mandibular Fractures

As listed by the trial registrant

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

Mandibular fractures

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029-6574, United States

  • Ludwig-Maximillians University

    München, Germany

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