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

NCT ID: NCT02341443

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-05-31

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.

Conditions

Mandibular Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rigid

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

Group Type: EXPERIMENTAL

Implants

Intervention Type: PROCEDURE

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.

Non-rigid

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

Group Type: ACTIVE_COMPARATOR

Implants

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Open reduction and internal fixation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AOCMF

OTHER

Sponsor Role: collaborator

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Risto Kontio, MD DDS PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Edward Ellis III, DDS MS

Role: PRINCIPAL_INVESTIGATOR

UT Health Science Center at San Antonio

Locations

Jacobi Medical Center

New York, New York, United States

UT Health Science Center at San Antonio

San Antonio, Texas, United States

Helsinki University Hospital

Helsinki, , Finland

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Ludwig-Maximillians University

München, , Germany

Hospital Sg Buloh

Sungai Buloh, , Malaysia

Hamad Medical Corporation

Doha, , Qatar

Emergency Clinical County Hospital of Constanta

Constanța, , Romania

King Edward VIII Hospital

Durban, , South Africa

12 de Octubre University Hospital

Madrid, , Spain

Lviv Regional Clinical Hospital (Lviv National Medical University)

Lviv, , Ukraine

Countries

United States; Finland; Germany; Malaysia; Qatar; Romania; South Africa; Spain; Ukraine

References

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.

Reference Type: RESULT

PMID: 32589939 (View on PubMed)

Other Identifiers

CIP_DMFx_V1.0

Identifier Type: -

Identifier Source: org_study_id