Focused Registry to Collect Clinical Data on the MatrixWAVE System

Mandibular Fractures Clinical Trial

— FRMatrixWAVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03405389
• Other study ID #: FR_MatrixWave
• Status: Recruiting
• Start date: June 20, 2019
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: AO Innovation Translation Center
• Contact: Cynthia Sob
• Phone: +41798937428
• Email: cynthia.sob[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mandibular Fractures

Intervention

Procedure:
• MatrixWAVE MMF System
Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion

Locations

Country	Name	City	State
Germany	Ludwig-Maximillians University	München
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of application	Time required by the surgeons to apply the MatrixWAVE MMF system	Intraoperative
Secondary	Patient-reported outcome (Likert scale)	Effect of MatrixWAVE MMF system on daily-life activities (speaking, eating and chewing, kissing)	6 weeks