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CompletedNCT03405389MatrixWAVEUpdated Sep 16, 2025

Focused Registry to Collect Clinical Data on the MatrixWAVE System

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

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
44
Ages
18 Years and older
Sex
All
01

Study summary

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 :

  • surgical technique
  • application time
  • intra- and postoperative complications
  • short term patient-reported outcomes
Read the detailed description

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.

02

Conditions studied

  • Mandibular Fractures

Keywords

  • mandibulo-maxillary fixation
  • malocclusion
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
44 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Patients

    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

Interventions

  • ProcedureMatrixWAVE MMF System

    Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion

05

What researchers measure

Primary outcomes

  1. Time of application

    Time required by the surgeons to apply the MatrixWAVE MMF system

    Time frame: Intraoperative

Secondary outcomes

  1. Patient-reported outcome (Likert scale)

    Effect of MatrixWAVE MMF system on daily-life activities (speaking, eating and chewing, kissing)

    Time frame: 6 weeks

06

Study locations

2 sites
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029-6574, United States
  • Ludwig-Maximillians University
    München, Germany
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03405389
Lead sponsor
AO Innovation Translation Center
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Jun 20, 2019
Primary completion
Apr 1, 2025
Completion
Apr 1, 2025
Last update
Sep 16, 2025

Study contacts

Paris Liokatis, Dr. med.
principal investigator · Klinikum der Universität München

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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