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

Mandibular Fractures Clinical Trial

— DMFx  

Official title:

A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341443
• Other study ID #: CIP_DMFx_V1.0
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: May 2019

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

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.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Ludwig-Maximillians University	München
Malaysia	Hospital Sg Buloh	Sungai Buloh
Qatar	Hamad Medical Corporation	Doha
Romania	Emergency Clinical County Hospital of Constanta	Constanta
South Africa	King Edward VIII Hospital	Durban
Spain	12 de Octubre University Hospital	Madrid
Ukraine	Lviv Regional Clinical Hospital (Lviv National Medical University)	Lviv
United States	Jacobi Medical Center	New York	New York
United States	UT Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation	AOCMF

Countries where clinical trial is conducted

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

References & 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, Csáki G, Sánchez-Aniceto G, Pérez D, Cornelius CP, Alani B, Vlad D, Kontio R, Ellis E 3rd. Combination of Rigid and Nonrigid Fixatio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of anticipated procedure- or condition-related Adverse Events		6 weeks
Secondary	Degree of displacement of the fracture		Pre-operatively (Day -1)
Secondary	Location of the tooth with respect to the line of fracture		Pre-operatively (Day -1)
Secondary	Mechanism of production of the fracture:		Pre-operatively (Day -1)
Secondary	Time in days between the occurrence of the injury and the surgery		Intraoperatively (Day 0)
Secondary	Length of the surgery	Time in minutes from the first incision to skin closure	Intraoperatively (Day 0)
Secondary	Length of the hospital stay	Time in days between the admission and the discharge of the (acute) hospital	Intraoperatively (Day 0)
Secondary	Characteristics of the hardware	Characteristics of the hardware/device used to reduce the fracture concerning its shape, thickness and number or screws	Intraoperatively (Day 0)
Secondary	Use of antibiotics	Administration of antibiotics during surgery	Intraoperatively (Day 0)
Secondary	Difficulty of application of the hardware	Surgeon's own assessment of difficulty of application of the hardware from very easy to very difficult	Intraoperatively (Day 0)
Secondary	Dysfunction of the mandible	Helkimo Index	6 weeks, 3 months

External Links

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