Status:
COMPLETED
Focused Registry to Collect Clinical Data on the MatrixWAVE System
Lead Sponsor:
AO Innovation Translation Center
Conditions:
Mandibular Fractures
Eligibility:
All Genders
18+ years
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 p...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03405389
Start Date
June 20 2019
End Date
April 1 2025
Last Update
September 16 2025
Active Locations (2)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029-6574
2
Ludwig-Maximillians University
München, Germany