Focused Registry to Collect Clinical Data on the MatrixWAVE System

NCT03405389 | Completed

• 1 other identifier: FR_MatrixWave
• Study Type: observational
• Target: 44
• Locations: 2 countries
• Sites: 2

Brief 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

Conditions

Mandibular Fractures

Keywords

mandibulo-maxillary fixation; malocclusion

Outcome Measures

Primary Outcomes (1)

• Time of application

  Time required by the surgeons to apply the MatrixWAVE MMF system

  Intraoperative

Secondary Outcomes (1)

• Patient-reported outcome (Likert scale)

  6 weeks

Study Arms (1)

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

Interventions

MatrixWAVE MMF System PROCEDURE

Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

Location

Ludwig-Maximillians University

München, Germany

Location

MeSH Terms

Conditions

Mandibular Fractures; Malocclusion

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Paris Liokatis, Dr. med.

  Klinikum der Universität München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 23, 2018
• Study Start: June 20, 2019
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); US (1)