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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MatrixWAVE MMF System | Procedure | Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time of application | Time required by the surgeons to apply the MatrixWAVE MMF system | Intraoperative |
| 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 |
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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.:
Exclusion Criteria:
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Patients older than 18 years old suffering with a mandibilar fracture without involvement of the condyle(s) or maxilla.
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| Name | Affiliation | Role |
|---|---|---|
| Paris Liokatis, Dr. med. | Klinikum der Universität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029-6574 | United States | ||
| Ludwig-Maximillians University |
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| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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| München |
| Germany |
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |