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

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

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.

Study Overview

• Status: Completed
• Conditions: Mandibular Fractures
• Intervention / Treatment: Procedure: Implants

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.

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Hospital
• Germany
  • Hamburg, Germany
    • University Medical Center Hamburg-Eppendorf
  • München, Germany
    • Ludwig-Maximillians University
• Malaysia
  • Sungai Buloh, Malaysia
    • Hospital Sg Buloh
• Qatar
  • Doha, Qatar
    • Hamad Medical Corporation
• Romania
  • Constanta, Romania
    • Emergency Clinical County Hospital of Constanta
• South Africa
  • Durban, South Africa
    • King Edward VIII Hospital
• Spain
  • Madrid, Spain
    • 12 de Octubre University Hospital
• Ukraine
  • Lviv, Ukraine
    • Lviv Regional Clinical Hospital (Lviv National Medical University)
• United States
  • New York
    • New York, New York, United States, 10461
      • Jacobi Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229-3900
      • UT Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rigid; Surgery using mandibulo-maxillary fixation, implants providing rigid fixation on most anterior fracture and non-rigid fixation on the most posterior fracture.	Procedure: Implants; 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.; Other Names: Open reduction and internal fixation
Active Comparator: Non-rigid; Surgery using mandibulo-maxillary fixation and implants providing non-rigid fixation on both fracture sides.	Procedure: Implants; 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.; Other Names: Open reduction and internal fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Collaborators: AOCMF
• Investigators: Principal Investigator: Risto Kontio, MD DDS PhD, Helsinki University Central Hospital; Principal Investigator: Edward Ellis III, DDS MS, UT Health Science Center at San Antonio

Publications and helpful links

General Publications

• 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.

Helpful Links

• Sponsor's website

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: January 14, 2015
• First Posted (Estimate): January 19, 2015

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: rigid fixation; jaw; bilateral double mandibular fractures; no-rigid fixation
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Mandibular Fractures
• Other Study ID Numbers: CIP_DMFx_V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO