Mandibular FracturesMatrixWAVENCT03405389
Focused Registry to Collect Clinical Data on the MatrixWAVE System
An observational study of Mandibular Fractures, run by AO Innovation Translation Center at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- MatrixWAVE MMF System
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Jun 2019to 1 Apr 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years old suffering with a mandibilar fracture without involvement of the condyle(s) or maxilla.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6574
About this study
Official title: An International, Multicenter, Focused Registry to Collect Clinical Data on the MatrixWAVE Mandibulo-Maxillary Fixation System
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.
- Conditions
- Mandibular Fractures
- Being tested
- MatrixWAVE MMF System
- Keywords
- mandibulo-maxillary fixation, malocclusion
- Medical subject headings
- Mandibular Fractures, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MatrixWAVE MMF SystemProcedure or surgery
Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: MatrixWAVE MMF System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of application
Time required by the surgeons to apply the MatrixWAVE MMF system
Measured: Intraoperative
Secondary outcomes (1)
Patient-reported outcome (Likert scale)
Effect of MatrixWAVE MMF system on daily-life activities (speaking, eating and chewing, kissing)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start20 Jun 2019
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paris Liokatis, Dr. med., Principal investigator, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405389
- Sponsor's protocol ID
- FR_MatrixWave
- Acronym
- MatrixWAVE
- Status last verified
- Sep 2025
- First submitted
- 11 Jan 2018
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicenter, Focused Registry to Collect Clinical Data on the MatrixWAVE Mandibulo-Maxillary Fixation System
- ClinicalTrials.gov ID
- NCT03405389
- Acronym / sponsor ID
- MatrixWAVE / FR_MatrixWave
- Conditions
- Mandibular Fractures
- Keywords
- mandibulo-maxillary fixation, malocclusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: MatrixWAVE MMF SystemPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years old suffering with a mandibilar fracture without involvement of the condyle(s) or maxilla.
Key inclusion criteria (6 listed)
- 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.:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MatrixWAVE MMF SystemStandard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion | Procedure or surgery | Patients |
Primary outcome
Time of application
Time frame: Intraoperative
Time required by the surgeons to apply the MatrixWAVE MMF system
1 secondary outcome
Patient-reported outcome (Likert scale)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paris Liokatis, Dr. med. principal investigator
LMU Klinikum
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Fractures, run by AO Innovation Translation Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of application (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.