Focused Registry to Collect Clinical Data on the MatrixWAVE System (NCT03405389) | Clinical Trial Compass
CompletedNot Applicable
Focused Registry to Collect Clinical Data on the MatrixWAVE System
United States, Germany44 participantsStarted 2019-06-20
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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