---
title: Focused Registry to Collect Clinical Data on the MatrixWAVE System
nct_id: NCT03405389
overall_status: COMPLETED
sponsor: AO Innovation Translation Center
study_type: OBSERVATIONAL
primary_condition: Mandibular Fractures
countries: United States, Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03405389.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03405389"
ct_last_update_post_date: 2025-09-16
last_seen_at: "2026-05-12T06:50:42.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Focused Registry to Collect Clinical Data on the MatrixWAVE System

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

**NCT ID:** [NCT03405389](https://clinicaltrials.gov/study/NCT03405389)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 44
- **Lead Sponsor:** AO Innovation Translation Center
- **Conditions:** Mandibular Fractures
- **Start Date:** 2019-06-20
- **Completion Date:** 2025-04-01
- **CT.gov Last Update:** 2025-09-16

## 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

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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

## Interventions

- **MatrixWAVE MMF System** (PROCEDURE) — Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion

## Primary Outcomes

- **Time of application** _(time frame: Intraoperative)_ — Time required by the surgeons to apply the MatrixWAVE MMF system

## Secondary Outcomes

- **Patient-reported outcome (Likert scale)** _(time frame: 6 weeks)_

## Locations (2)

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

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.icahn school of medicine at mount sinai|new york|new york|united states` — added _(2026-05-12)_
- `locations.ludwig-maximillians university|münchen||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03405389.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03405389*  
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