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| Name | Class |
|---|---|
| AOCMF | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rigid | Experimental | Surgery 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 | Surgery using mandibulo-maxillary fixation and implants providing non-rigid fixation on both fracture sides. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of anticipated procedure- or condition-related Adverse Events | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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: |
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Inclusion Criteria:
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)
Signed and dated IRB/EC-approved written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center | New York | New York | 10461 | United States | ||
| UT Health Science Center at San Antonio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32589939 | Result | 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. |
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|
|
| Pre-operatively (Day -1) |
| Time in days between the occurrence of the injury and the surgery | Intraoperatively (Day 0) |
| Length of the surgery | Time in minutes from the first incision to skin closure | Intraoperatively (Day 0) |
| Length of the hospital stay | Time in days between the admission and the discharge of the (acute) hospital | 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 | Intraoperatively (Day 0) |
| Use of antibiotics | Administration of antibiotics during surgery | 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 | Intraoperatively (Day 0) |
| Dysfunction of the mandible | Helkimo Index | 6 weeks, 3 months |
| San Antonio |
| Texas |
| 78229-3900 |
| United States |
| Helsinki University Hospital | Helsinki | 00029 | 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 |
| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| D000070799 | Open Fracture Reduction |
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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