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

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Mandibular Fractures

Treatments: Procedure: Implants

Study type: Interventional

Funder types: Other

Identifiers

NCT02341443

CIP_DMFx_V1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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314 participants in 2 patient groups

Rigid

Experimental group

Description:

Surgery using mandibulo-maxillary fixation, implants providing rigid fixation on most anterior fracture and non-rigid fixation on the most posterior fracture.

Treatment:

Procedure: Implants

Non-rigid

Active Comparator group

Description:

Surgery using mandibulo-maxillary fixation and implants providing non-rigid fixation on both fracture sides.

Treatment:

Procedure: Implants