Clinical trial NCT03405389: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mandibular Fractures
Keywords: mandibulo-maxillary fixation
malocclusion
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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 criteria: 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

Primary outcomes:
measure: Time of application
timeFrame: Intraoperative
Secondary outcomes:
measure: Patient-reported outcome (Likert scale)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: München
country: Germany
facility: Ludwig-Maximillians University
Study officials:
affiliation: Klinikum der Universität München
name: Paris Liokatis, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: