Focused Registry to Collect Clinical Data on the MatrixWAVE System (FRMatrixWAVE)

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

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

Study Overview

• Status: Recruiting
• Conditions: Mandibular Fractures
• Intervention / Treatment: Procedure: MatrixWAVE MMF System

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Viola Grünenfelder; Email: viola.gruenenfelder@aofoundation.org
• Study Contact Backup: Name: Cynthia Sob; Phone Number: +41798937428; Email: cynthia.sob@aofoundation.org

Study Locations

• Germany
  • München, Germany
    • Recruiting
    • Ludwig-Maximillians University
    • Contact: Paris Georgios Liokatis, Dr. med.; Phone Number: +4989440054475; Email: Paris.Liokatis@med.uni-muenchen.de
• United States
  • New York
    • New York, New York, United States, 10029-6574
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Michael Turner, MD; Email: Michael.Turner@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients older than 18 years old suffering with a mandibilar fracture without involvement of the condyle(s) or maxilla.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: MatrixWAVE MMF System; Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of application	Time required by the surgeons to apply the MatrixWAVE MMF system	Intraoperative

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Paris Liokatis, Dr. med., Klinikum der Universität München

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: malocclusion; mandibulo-maxillary fixation
• Additional Relevant MeSH Terms: Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Mandibular Fractures
• Other Study ID Numbers: FR_MatrixWave

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No