NCT03405389

Focused Registry to Collect Clinical Data on the MatrixWAVE System

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: AO Innovation Translation Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
PROCEDURE	MatrixWAVE MMF System	Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion

Timeline

• Start date: 2019-06-20
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2018-01-23
• Last updated: 2025-09-16

Locations

2 sites across 2 countries: United States, Germany