Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02341443
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
AOCMF
Information provided by (Responsible Party):
AO Innovation Translation Center ( AO Clinical Investigation and Publishing Documentation )

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.


Condition or disease Intervention/treatment Phase
Mandibular Fractures Procedure: Implants Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
Study Start Date : April 2015
Actual Primary Completion Date : March 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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 Name: 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 Name: Open reduction and internal fixation




Primary Outcome Measures :
  1. Number of anticipated procedure- or condition-related Adverse Events [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Degree of displacement of the fracture [ Time Frame: Pre-operatively (Day -1) ]
  2. Location of the tooth with respect to the line of fracture [ Time Frame: Pre-operatively (Day -1) ]
  3. Mechanism of production of the fracture: [ Time Frame: Pre-operatively (Day -1) ]
  4. Time in days between the occurrence of the injury and the surgery [ Time Frame: Intraoperatively (Day 0) ]
  5. Length of the surgery [ Time Frame: Intraoperatively (Day 0) ]
    Time in minutes from the first incision to skin closure

  6. Length of the hospital stay [ Time Frame: Intraoperatively (Day 0) ]
    Time in days between the admission and the discharge of the (acute) hospital

  7. Characteristics of the hardware [ Time Frame: Intraoperatively (Day 0) ]
    Characteristics of the hardware/device used to reduce the fracture concerning its shape, thickness and number or screws

  8. Use of antibiotics [ Time Frame: Intraoperatively (Day 0) ]
    Administration of antibiotics during surgery

  9. Difficulty of application of the hardware [ Time Frame: Intraoperatively (Day 0) ]
    Surgeon's own assessment of difficulty of application of the hardware from very easy to very difficult

  10. Dysfunction of the mandible [ Time Frame: 6 weeks, 3 months ]
    Helkimo Index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341443


Locations
Layout table for location information
United States, New York
Jacobi Medical Center
New York, New York, United States, 10461
United States, Texas
UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Finland
Helsinki University Hospital
Helsinki, Finland, 00029
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Ludwig-Maximillians University
München, Germany
Malaysia
Hospital Sg Buloh
Sungai Buloh, Malaysia
Qatar
Hamad Medical Corporation
Doha, Qatar
Romania
Emergency Clinical County Hospital of Constanta
Constanta, Romania
South Africa
King Edward VIII Hospital
Durban, South Africa
Spain
12 de Octubre University Hospital
Madrid, Spain
Ukraine
Lviv Regional Clinical Hospital (Lviv National Medical University)
Lviv, Ukraine
Sponsors and Collaborators
AO Clinical Investigation and Publishing Documentation
AOCMF
Investigators
Layout table for investigator information
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
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: AO Clinical Investigation and Publishing Documentation
ClinicalTrials.gov Identifier: NCT02341443    
Other Study ID Numbers: CIP_DMFx_V1.0
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AO Innovation Translation Center ( AO Clinical Investigation and Publishing Documentation ):
bilateral double mandibular fractures
rigid fixation
no-rigid fixation
jaw
Additional relevant MeSH terms:
Layout table for MeSH terms
Mandibular Fractures
Fractures, Bone
Wounds and Injuries
Jaw Fractures
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures