Clinical trial NCT02341443: A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
Official title: A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Fractures
Keywords: bilateral double mandibular fractures
rigid fixation
no-rigid fixation
jaw
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AOCMF
First posted: 2015-01-19
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of anticipated procedure- or condition-related Adverse Events
timeFrame: 6 weeks
Secondary outcomes:
measure: Degree of displacement of the fracture
timeFrame: Pre-operatively (Day -1)
measure: Location of the tooth with respect to the line of fracture
timeFrame: Pre-operatively (Day -1)
measure: Mechanism of production of the fracture:
timeFrame: Pre-operatively (Day -1)
measure: Time in days between the occurrence of the injury and the surgery
timeFrame: Intraoperatively (Day 0)
measure: Length of the surgery
timeFrame: Intraoperatively (Day 0)
measure: Length of the hospital stay
timeFrame: Intraoperatively (Day 0)
measure: Characteristics of the hardware
timeFrame: Intraoperatively (Day 0)
measure: Use of antibiotics
timeFrame: Intraoperatively (Day 0)
measure: Difficulty of application of the hardware
timeFrame: Intraoperatively (Day 0)
measure: Dysfunction of the mandible
timeFrame: 6 weeks, 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Jacobi Medical Center
state: New York
city: San Antonio
country: United States
facility: UT Health Science Center at San Antonio
state: Texas
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
city: München
country: Germany
facility: Ludwig-Maximillians University
city: Sungai Buloh
country: Malaysia
facility: Hospital Sg Buloh
city: Doha
country: Qatar
facility: Hamad Medical Corporation
city: Constanta
country: Romania
facility: Emergency Clinical County Hospital of Constanta
city: Durban
country: South Africa
facility: King Edward VIII Hospital
city: Madrid
country: Spain
facility: 12 de Octubre University Hospital
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital (Lviv National Medical University)
Study officials:
affiliation: Helsinki University Central Hospital
name: Risto Kontio, MD DDS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Health Science Center at San Antonio
name: Edward Ellis III, DDS MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rughubar V, Vares Y, Singh P, Filipsky A, Creanga A, Iqbal S, Alkhalil M, Kormi E, Hanken H, Calle AR, Smolka W, Turner M, Csaki G, Sanchez-Aniceto G, Perez D, Cornelius CP, Alani B, Vlad D, Kontio R, Ellis E 3rd. Combination of Rigid and Nonrigid Fixation Versus Nonrigid Fixation for Bilateral Mandibular Fractures: A Multicenter Randomized Controlled Trial. J Oral Maxillofac Surg. 2020 Oct;78(10):1781-1794. doi: 10.1016/j.joms.2020.05.012. Epub 2020 May 15.