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

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ClinicalTrials.gov Identifier: NCT03405389
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Brief Summary:

Following standard of care (routine) procedures, a total number of 50 patients suffering from a non-condylar and/or condylar fractures of the mandible requiring Mandibulo-maxillary fixation (MMF) for a minimum of two weeks during or subsequent to open reduction internal fixation (ORIF) will be prospectively enrolled in this focused registry.

Classification of the injury and the time needed for application of the MatrixWAVE MMF system will be collected. Follow-up visits will be performed between 2 to 6 weeks and 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 MMF system.


Condition or disease Intervention/treatment
Mandibular Fractures Procedure: MatrixWAVE MMF System

Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: An International, Multicenter, Focused Registry to Collect Clinical Data on the MatrixWAVE Mandibulo-Maxillary Fixation System
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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




Primary Outcome Measures :
  1. Time of application [ Time Frame: Intraoperative ]
    Time required by the surgeons to apply the MatrixWAVE MMF system


Secondary Outcome Measures :
  1. Patient-reported outcome (Likert scale) [ Time Frame: 6 weeks ]
    Effect of MatrixWAVE MMF system on daily-life activities (speaking, eating and chewing, kissing)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405389


Locations
Germany
Ludwig-Maximillians University
München, Germany
Sponsors and Collaborators
AO Clinical Investigation and Documentation

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT03405389     History of Changes
Other Study ID Numbers: FR_MatrixWave
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AO Clinical Investigation and Documentation:
mandibulo-maxillary fixation
malocclusion

Additional relevant MeSH terms:
Mandibular Fractures
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Fractures, Bone
Wounds and Injuries