A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures

Conditions
-----------------
Mandibular Fractures

Intervention / Treatment
-----------------
* Procedure: Implants


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rigid<br>Surgery using mandibulo-maxillary fixation, implants providing rigid fixation on most anterior fracture and non-rigid fixation on the most posterior fracture. | Procedure: Implants<br>* Experimental arm: Rigid Surgical treatment using arch bars and according to the following fixation: Rigid fixation on one side (most anterior fracture) and non-rigid fixation on the other (most posterior fracture). Active comparator: Non-rigid Surgical treatment using arch bars and according to the following fixation: Non-rigid fixation on both fracture sides. Whereas non-rigid fixation is defined as a single miniplate of ≤1.00 mm thickness, and rigid fixation is defined as a single plate of ≥1.25 mm thickness, a combination of 2 plates or a 3D geometric plate.<br>* Other names: Open reduction and internal fixation;|
| Active Comparator: Non-rigid<br>Surgery using mandibulo-maxillary fixation and implants providing non-rigid fixation on both fracture sides. | Procedure: Implants<br>* Experimental arm: Rigid Surgical treatment using arch bars and according to the following fixation: Rigid fixation on one side (most anterior fracture) and non-rigid fixation on the other (most posterior fracture). Active comparator: Non-rigid Surgical treatment using arch bars and according to the following fixation: Non-rigid fixation on both fracture sides. Whereas non-rigid fixation is defined as a single miniplate of ≤1.00 mm thickness, and rigid fixation is defined as a single plate of ≥1.25 mm thickness, a combination of 2 plates or a 3D geometric plate.<br>* Other names: Open reduction and internal fixation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of anticipated procedure- or condition-related Adverse Events |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of displacement of the fracture |  | Pre-operatively (Day -1) | 
| Location of the tooth with respect to the line of fracture |  | Pre-operatively (Day -1) | 
| Mechanism of production of the fracture: |  | Pre-operatively (Day -1) | 
| Time in days between the occurrence of the injury and the surgery |  | Intraoperatively (Day 0) | 
| Length of the surgery | Time in minutes from the first incision to skin closure | Intraoperatively (Day 0) | 
| Length of the hospital stay | Time in days between the admission and the discharge of the (acute) hospital | Intraoperatively (Day 0) | 
| Characteristics of the hardware | Characteristics of the hardware/device used to reduce the fracture concerning its shape, thickness and number or screws | Intraoperatively (Day 0) | 
| Use of antibiotics | Administration of antibiotics during surgery | Intraoperatively (Day 0) | 
| Difficulty of application of the hardware | Surgeon's own assessment of difficulty of application of the hardware from very easy to very difficult | Intraoperatively (Day 0) | 
| Dysfunction of the mandible | Helkimo Index | 6 weeks, 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rigid fixation, bilateral double mandibular fractures, no-rigid fixation, jaw