Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AO Clinical Investigation and Publishing Documentation
With
AOCMF
Prospective data will be collected in 314 patients suffering from bilateral (double) mandibular fracture randomly treated either with non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side. This is a study where patients will be treated per randomization to one of the two established treatments and followed for further clinical examination post-operatively at 6 weeks and 3 months after the intervention.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 years or older at the date of the surgery
Diagnosis of bilateral (double) mandibular fracture located in:
* Angle and body or
* Angle and symphysis or
* Body and symphysis
Dentition: Patients must have most of their maxillary and mandibular teeth present and it must be possible to identify proper occlusion. The application of intraoperative Mandibulo-maxillary fixation (MMF) using arch bars must be possible
Ability to understand the content of the patient information / Informed Consent Form
Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
Signed and dated IRB/EC-approved written informed consent
You may not be if
Fractures displaying continuity defect or comminution
Fractures showing clinical signs of infection at presentation
Edentulous mandible fracture
Fractures requiring an extra-oral surgical approach
Concomitant maxillary fractures
Concomitant condylar fracture
Prior surgical treatment of the mandibular fracture(s)
Atrophy of the mandible (\<20 mm vertical height) at the level of the fracture(s)
Polytrauma (i.e. severe injuries leading to life-threatening condition)
Prisoners
Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
