A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures (NCT02341443) | Clinical Trial Compass
CompletedNot Applicable
A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
United States, Finland, Germany314 participantsStarted 2015-04
Plain-language summary
Mandibular fractures represent approximately 50% of the total facial fractures and are commonly (more than half) presented in more than one location. A few simple fractures can be treated using a conservative approach. More often, however, mandibular fractures require stabilization using open reduction and internal fixation.
Simple mandibular fractures can be treated using non-rigid fixation techniques that rely on the load-sharing principle, by which stabilization is accomplished with both fixation devices and bone surfaces. On the other hand, more complex fractures with continuity defects or comminuted need to be handle using rigid fixation where the device assumes all the forces (load-bearing principle). These approaches are well established, whereas the level of evidence for the treatment of bilateral double mandibular fractures (DMF) is still scarce. In fact, which surgical treatment, or combination of treatments, leads to the best outcome and the lowest rate of complications in bilateral DMFs is an open question.
The purpose of this study is to assess the complication rate in patients suffering from bilateral DMF treated either using non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of anticipated procedure- or condition-related Adverse Events
Timeframe: 6 weeks
Trial details
NCT IDNCT02341443
SponsorAO Clinical Investigation and Publishing Documentation