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

Primary Purpose

Mandibular Fractures

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implants
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Fractures focused on measuring bilateral double mandibular fractures, rigid fixation, no-rigid fixation, jaw

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jacobi Medical Center
  • UT Health Science Center at San Antonio
  • Helsinki University Hospital
  • University Medical Center Hamburg-Eppendorf
  • Ludwig-Maximillians University
  • Hospital Sg Buloh
  • Hamad Medical Corporation
  • Emergency Clinical County Hospital of Constanta
  • King Edward VIII Hospital
  • 12 de Octubre University Hospital
  • Lviv Regional Clinical Hospital (Lviv National Medical University)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rigid

Non-rigid

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of anticipated procedure- or condition-related Adverse Events

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2014
Last Updated
August 17, 2020
Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
AOCMF
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1. Study Identification

Unique Protocol Identification Number
NCT02341443
Brief Title
A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
Acronym
DMFx
Official Title
A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
AOCMF

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Fractures
Keywords
bilateral double mandibular fractures, rigid fixation, no-rigid fixation, jaw

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rigid
Arm Type
Experimental
Arm Description
Surgery using mandibulo-maxillary fixation, implants providing rigid fixation on most anterior fracture and non-rigid fixation on the most posterior fracture.
Arm Title
Non-rigid
Arm Type
Active Comparator
Arm Description
Surgery using mandibulo-maxillary fixation and implants providing non-rigid fixation on both fracture sides.
Intervention Type
Procedure
Intervention Name(s)
Implants
Other Intervention Name(s)
Open reduction and internal fixation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of anticipated procedure- or condition-related Adverse Events
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Degree of displacement of the fracture
Time Frame
Pre-operatively (Day -1)
Title
Location of the tooth with respect to the line of fracture
Time Frame
Pre-operatively (Day -1)
Title
Mechanism of production of the fracture:
Time Frame
Pre-operatively (Day -1)
Title
Time in days between the occurrence of the injury and the surgery
Time Frame
Intraoperatively (Day 0)
Title
Length of the surgery
Description
Time in minutes from the first incision to skin closure
Time Frame
Intraoperatively (Day 0)
Title
Length of the hospital stay
Description
Time in days between the admission and the discharge of the (acute) hospital
Time Frame
Intraoperatively (Day 0)
Title
Characteristics of the hardware
Description
Characteristics of the hardware/device used to reduce the fracture concerning its shape, thickness and number or screws
Time Frame
Intraoperatively (Day 0)
Title
Use of antibiotics
Description
Administration of antibiotics during surgery
Time Frame
Intraoperatively (Day 0)
Title
Difficulty of application of the hardware
Description
Surgeon's own assessment of difficulty of application of the hardware from very easy to very difficult
Time Frame
Intraoperatively (Day 0)
Title
Dysfunction of the mandible
Description
Helkimo Index
Time Frame
6 weeks, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Risto Kontio, MD DDS PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward Ellis III, DDS MS
Organizational Affiliation
UT Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
UT Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Ludwig-Maximillians University
City
München
Country
Germany
Facility Name
Hospital Sg Buloh
City
Sungai Buloh
Country
Malaysia
Facility Name
Hamad Medical Corporation
City
Doha
Country
Qatar
Facility Name
Emergency Clinical County Hospital of Constanta
City
Constanta
Country
Romania
Facility Name
King Edward VIII Hospital
City
Durban
Country
South Africa
Facility Name
12 de Octubre University Hospital
City
Madrid
Country
Spain
Facility Name
Lviv Regional Clinical Hospital (Lviv National Medical University)
City
Lviv
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32589939
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.
Results Reference
result
Links:
URL
https://www.aofoundation.org/what-we-do/clinical-evidence
Description
Sponsor's website

Learn more about this trial

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

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