Focused Registry to Collect Clinical Data on the MatrixWAVE System

Study Overview
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Brief Summary
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Following standard of care (routine) procedures, a total number of 50 patients suffering from a non-condylar and/or condylar fractures of the mandible requiring Mandibulo-maxillary fixation (MMF) for a minimum of two weeks during or subsequent to open reduction internal fixation (ORIF) will be prospectively enrolled in this focused registry. Classification of the injury and the time needed for application of the MatrixWAVE MMF system will be collected. Follow-up visits will be performed between 2 to 6 weeks and 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 MMF system.

Official Title
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An International, Multicenter, Focused Registry to Collect Clinical Data on the MatrixWAVE Mandibulo-Maxillary Fixation System

Conditions
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Mandibular Fractures

Intervention / Treatment
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* Procedure: MatrixWAVE MMF System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>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<br>* Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of application | Time required by the surgeons to apply the MatrixWAVE MMF system | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcome (Likert scale) | Effect of MatrixWAVE MMF system on daily-life activities (speaking, eating and chewing, kissing) | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mandibulo-maxillary fixation, malocclusion