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

NCT02341443 | Completed

• 1 other identifier: CIP_DMFx_V1.0
• Study Type: interventional
• Target: 314
• Locations: 9 countries
• Sites: 11

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.

Conditions

Mandibular Fractures

Keywords

bilateral double mandibular fractures; rigid fixation; no-rigid fixation; jaw

Outcome Measures

Primary Outcomes (1)

• Number of anticipated procedure- or condition-related Adverse Events

  6 weeks

Secondary Outcomes (10)

• 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

  Intraoperatively (Day 0)

Study Arms (2)

Rigid

EXPERIMENTAL

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

Procedure: Implants

Non-rigid

ACTIVE COMPARATOR

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

Procedure: Implants

Interventions

Implants 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.

Also known as: Open reduction and internal fixation

Non-rigid; Rigid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead
• AOCMF: collaborator

Study Sites (11)

Jacobi Medical Center

New York, New York, 10461, United States

Location

UT Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Helsinki University Hospital

Helsinki, 00029, Finland

Location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Ludwig-Maximillians University

München, Germany

Location

Hospital Sg Buloh

Sungai Buloh, Malaysia

Location

Hamad Medical Corporation

Doha, Qatar

Location

Emergency Clinical County Hospital of Constanta

Constanța, Romania

Location

King Edward VIII Hospital

Durban, South Africa

Location

12 de Octubre University Hospital

Madrid, Spain

Location

Lviv Regional Clinical Hospital (Lviv National Medical University)

Lviv, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 32589939 RESULT

MeSH Terms

Conditions

Mandibular Fractures

Interventions

Drug Implants; Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Risto Kontio, MD DDS PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Edward Ellis III, DDS MS

  UT Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: January 19, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1); US (2); MY (1); DE (2); RO (1); ZA (1); ES (1); UA (1); FI (1)