Focused Registry to Collect Clinical Data on the MatrixWAVE System

Completed

Conditions studied: Mandibular Fractures

In brief

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

Key facts

Study ID

NCT03405389

Run by

AO Innovation Translation Center

People needed

44

Starts

2019-06-20

Expected to finish

2025-04-01

Last updated by the study team

2025-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Ludwig-Maximillians University — München, Germany

Full record on ClinicalTrials.gov

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