Focused Registry to Collect Clinical Data on the MatrixWAVE System

AO Innovation Translation Center

Status: Completed

Conditions: Mandibular Fractures

Treatments: Procedure: MatrixWAVE MMF System

Study type: Observational

Funder types: Other

Identifiers

NCT03405389

FR_MatrixWave

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

44 participants in 1 patient group

Patients

Description:

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

Treatment:

Procedure: MatrixWAVE MMF System