An observational study in Mandibular Fractures, sponsored by AO Innovation Translation Center. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by AO Innovation Translation Center · Observational
Among 14 studies in Mandibular Fractures with a site in United States — 1 open to participants now, 3 under way, none of them phase 3. Mandibular Fractures · United States.
Among the 14 studies in Mandibular Fractures with a site in United States, this one is one of 2 that started in 2019, is one of 8 observational ones, and was the 5th registered.
91 studies on the registry are indexed under Mandibular Fractures; 24 are open to participants now.
This study's enrollment of 44 is below the median of 50 across 18 observational studies indexed under Mandibular Fractures.
Browse Mandibular Fractures studies →1 of the 14 studies in Mandibular Fractures with a site in United States is open now, in 1 country. Each count lists the studies.
Of the 11 Mandibular Fractures studies recruiting now, 2 (18%) set no upper age limit and 9 (82%) stop at 75 or younger; 1 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2019.
Median enrollment 48 across the 6 interventional studies, 47 across the 8 observational. Of the 11 that completed or were terminated, 3 (27%) have results posted.
4 of 14 have an industry lead sponsor. The 10 most frequent:
AO Innovation Translation Center is the lead sponsor of 32 studies on the registry; 11 are open to participants now.
AO Innovation Translation Center has 1 study filed under Mandibular Fractures — fewer than ten, so there is no comparison to draw.
1 of the studies in Mandibular Fractures with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05733221University of Cincinnati3D Printed Models for Mandibular Fracture Repair | 2026-12 |
Among the 14 studies in Mandibular Fractures with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
The goal of this registry is to evaluate the performance of the MatrixWAVE(TM) MMF system in patients suffering from non-condylar and/or condylar fractures. The evaluation will focus on the clinical performance in terms of :
Following standard of care (routine) procedures, a total number of 50 patients suffering from non-condylar and/or condylar fractures of the mandible requiring MMF for a minimum of two weeks during or subsequent to open reduction internal fixation (ORIF) will be prospectively enrolled in this registry.
Data on the classification of the injury (AO CMF fracture classification system) and the time needed for application of the MatrixWAVE(TM) MMF system will be collected.
Follow-up (FU) visits will be performed between 2 to 6 weeks and at 3 months according to standard of care to evaluate the mandible function impairment, pain and local complications (anticipated procedure-related adverse events) related to the MatrixWAVE(TM) MMF system.
Patients older than 18 years old suffering with a mandibilar fracture without involvement of the condyle(s) or maxilla.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
obtained, i.e.:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosis of a mandibular fracture requiring Open Reduction and Internal Fixation (ORIF) and use of Mandibulo-Maxillary fixation (MMF) during or subsequent to surgical intervention for a minimum of two weeks
Procedure: MatrixWAVE MMF System
Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion
Time of application
Time required by the surgeons to apply the MatrixWAVE MMF system
Time frame: Intraoperative
Patient-reported outcome (Likert scale)
Effect of MatrixWAVE MMF system on daily-life activities (speaking, eating and chewing, kissing)
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Apr 2025, 69 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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AO Innovation Translation Center