Focused Registry to Collect Clinical Data on the MatrixWAVE System (FR_MatrixWAVE)
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|ClinicalTrials.gov Identifier: NCT03405389|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : July 13, 2018
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.
|Condition or disease||Intervention/treatment|
|Mandibular Fractures||Procedure: MatrixWAVE MMF System|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||An International, Multicenter, Focused Registry to Collect Clinical Data on the MatrixWAVE Mandibulo-Maxillary Fixation System|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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 Frame: Intraoperative ]Time required by the surgeons to apply the MatrixWAVE MMF system
- Patient-reported outcome (Likert scale) [ Time Frame: 6 weeks ]Effect of MatrixWAVE MMF system on daily-life activities (speaking, eating and chewing, kissing)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405389