Mandibular FracturesDMFxNCT02341443
A Multicenter RCT to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
A study testing Implants in people with Mandibular Fractures, run by AO Clinical Investigation and Publishing Documentation at 11 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Fractures
- What is being tested?
- Implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 11 sitesin 9 countries
- Study dates
- Apr 2015to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
11 sites in 9 countries.
11 sites in 9 countries
United States2 sites
Jacobi Medical Center
New York, New York, 10461
UT Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Germany2 sites
University Medical Center Hamburg-Eppendorf
Hamburg
Ludwig-Maximillians University
München
Ukraine1 site
Lviv Regional Clinical Hospital (Lviv National Medical University)
Lviv
About this study
Official title: A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
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.
Read the 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
- Being tested
- Implants
- Keywords
- bilateral double mandibular fractures, rigid fixation, no-rigid fixation, jaw
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantsProcedure or surgery
Also called Open reduction and internal fixation
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.
| Study group | Role | What they receive |
|---|---|---|
| Rigid | Experimental | Surgery using mandibulo-maxillary fixation, implants providing rigid fixation on most anterior fracture and non-rigid fixation on the most posterior fracture. Receives: Procedure: Implants |
| Non-rigid | Active comparator | Surgery using mandibulo-maxillary fixation and implants providing non-rigid fixation on both fracture sides. Receives: Procedure: Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of anticipated procedure- or condition-related Adverse Events
Measured: 6 weeks
Secondary outcomes (10)
Degree of displacement of the fracture
Measured: Pre-operatively (Day -1)
Location of the tooth with respect to the line of fracture
Measured: Pre-operatively (Day -1)
Mechanism of production of the fracture:
Measured: Pre-operatively (Day -1)
Time in days between the occurrence of the injury and the surgery
Measured: Intraoperatively (Day 0)
Length of the surgery
Time in minutes from the first incision to skin closure
Measured: Intraoperatively (Day 0)
Length of the hospital stay
Time in days between the admission and the discharge of the (acute) hospital
Measured: Intraoperatively (Day 0)
Characteristics of the hardware
Characteristics of the hardware/device used to reduce the fracture concerning its shape, thickness and number or screws
Measured: Intraoperatively (Day 0)
Use of antibiotics
Administration of antibiotics during surgery
Measured: Intraoperatively (Day 0)
Difficulty of application of the hardware
Surgeon's own assessment of difficulty of application of the hardware from very easy to very difficult
Measured: Intraoperatively (Day 0)
Dysfunction of the mandible
Helkimo Index
Measured: 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mandibular FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- AOCMF
- Responsible party
- Sponsor
- Investigators
- Risto Kontio, MD DDS PhD, Principal investigator, Helsinki University Central HospitalEdward Ellis III, DDS MS, Principal investigator, UT Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341443
- Sponsor's protocol ID
- CIP_DMFx_V1.0
- Acronym
- DMFx
- Status last verified
- Aug 2020
- First submitted
- 4 Dec 2014
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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, 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.
PubMed 32589939
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
- ClinicalTrials.gov ID
- NCT02341443
- Acronym / sponsor ID
- DMFx / CIP_DMFx_V1.0
- Conditions
- Mandibular Fractures
- Keywords
- bilateral double mandibular fractures, rigid fixation, no-rigid fixation, jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- AOCMF
- Study start
- Apr 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rigid | Experimental | Procedure: ImplantsSurgery using mandibulo-maxillary fixation, implants providing rigid fixation on most anterior fracture and non-rigid fixation on the most posterior fracture. |
| Non-rigid | Active comparator | Procedure: ImplantsSurgery using mandibulo-maxillary fixation and implants providing non-rigid fixation on both fracture sides. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older at the date of the surgery
- Diagnosis of bilateral (double) mandibular fracture located in:
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImplantsAlso: Open reduction and internal fixationExperimental 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. | Procedure or surgery | Non-rigid, Rigid |
Primary outcome
Number of anticipated procedure- or condition-related Adverse Events
Time frame: 6 weeks
10 secondary outcomes
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)
Length of the hospital stay
Time frame: Intraoperatively (Day 0)
Characteristics of the hardware
Time frame: Intraoperatively (Day 0)
Use of antibiotics
Time frame: Intraoperatively (Day 0)
Difficulty of application of the hardware
Time frame: Intraoperatively (Day 0)
Dysfunction of the mandible
Time frame: 6 weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Results publication: PubMed 32589939Rughubar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Risto Kontio, MD DDS PhD principal investigator
Helsinki University Central Hospital
Edward Ellis III, DDS MS principal investigator
UT Health Science Center at San Antonio
11 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implants in people with Mandibular Fractures, run by AO Clinical Investigation and Publishing Documentation at 11 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Germany, Finland, Malaysia, Qatar and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of anticipated procedure- or condition-related Adverse Events (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.