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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 )

Tracking Information
First Submitted Date  ICMJE December 4, 2014
First Posted Date  ICMJE January 19, 2015
Last Update Posted Date August 19, 2020
Study Start Date  ICMJE April 2015
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2015)
Number of anticipated procedure- or condition-related Adverse Events [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2015)
  • Degree of displacement of the fracture [ Time Frame: Pre-operatively (Day -1) ]
  • Location of the tooth with respect to the line of fracture [ Time Frame: Pre-operatively (Day -1) ]
  • Mechanism of production of the fracture: [ Time Frame: Pre-operatively (Day -1) ]
  • Time in days between the occurrence of the injury and the surgery [ Time Frame: Intraoperatively (Day 0) ]
  • Length of the surgery [ Time Frame: Intraoperatively (Day 0) ]
    Time in minutes from the first incision to skin closure
  • Length of the hospital stay [ Time Frame: Intraoperatively (Day 0) ]
    Time in days between the admission and the discharge of the (acute) hospital
  • 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
  • Use of antibiotics [ Time Frame: Intraoperatively (Day 0) ]
    Administration of antibiotics during surgery
  • 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
  • Dysfunction of the mandible [ Time Frame: 6 weeks, 3 months ]
    Helkimo Index
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
Official Title  ICMJE A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mandibular Fractures
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Rigid
    Surgery using mandibulo-maxillary fixation, implants providing rigid fixation on most anterior fracture and non-rigid fixation on the most posterior fracture.
    Intervention: Procedure: Implants
  • Active Comparator: Non-rigid
    Surgery using mandibulo-maxillary fixation and implants providing non-rigid fixation on both fracture sides.
    Intervention: Procedure: Implants
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, Csáki G, Sánchez-Aniceto G, Pérez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2015)
314
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   Germany,   Malaysia,   Qatar,   Romania,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02341443
Other Study ID Numbers  ICMJE CIP_DMFx_V1.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AO Innovation Translation Center ( AO Clinical Investigation and Publishing Documentation )
Study Sponsor  ICMJE AO Clinical Investigation and Publishing Documentation
Collaborators  ICMJE AOCMF
Investigators  ICMJE
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
PRS Account AO Innovation Translation Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP