Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures

Study Overview
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Brief Summary
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The purpose of this trial is to compare operating room time between conventional treatment techniques (without Virtual surgical Planning (VSP)) versus use of VSP and surgically-guided techniques and to compare and contrast the effect of any other variables that might have an effect on the overall result

Official Title
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Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures

Conditions
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Mandibular Fractures

Intervention / Treatment
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* Device: Control group without use of VSP
* Device: Treatment Group with use of VSP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient consent Complex mandible fracture (at least two fractures) that require ORIF of at least one fracture. This will exclude condylar fractures Exclusion Criteria: Patient refusal to participate in study Infected mandible fracture Closed reduction treatment of mandible fracture Fractures older than 2-3 weeks at the time of treatment Other concomitant mid-facial bone fractures (ie, zygomaticomaxillary complex (ZMC), Lefort fractures) Other etiologies than trauma of the mandibular fracture or pathologic fracture secondary to benign or malignant pathology that may require resection Pregnant patients will NOT be excluded from the study Co-morbidities (auto-immune disease, osteoporosis, titanium or metal allergy, uncontrolled diabetes (A1c greater than 8)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br> | Device: Control group without use of VSP<br>* The control group will include patients that undergo mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) in standard fashion (without virtual surgical planning assistance and occlusal splint)<br>|
| Experimental: Treatment Group<br> | Device: Treatment Group with use of VSP<br>* The treatment group corresponds to patients undergoing mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) utilizing virtual surgical planning via 3D Systems, bite registration and fabrication of occlusal splint via intraoral digital scanner, and mandibular hardware<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time taken to complete an open reduction internal fixation (ORIF) |  | End of dissection until final screws are placed,about 2-3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with malocclusion |  | 1 week post surgery | 
| Number of participants with malocclusion |  | 3 weeks post surgery | 
| Number of participants with malocclusion |  | 6 weeks post surgery | 
| Number of participants with fractures that are not well aligned |  | 1 week post surgery | 
| Number of participants with fractures that are not well aligned |  | 3 weeks post surgery | 
| Number of participants with fractures that are not well aligned |  | 6 weeks post surgery | 
| Number of participants with infections |  | 1 week post surgery | 
| Number of participants with infections |  | 3 weeks post surgery | 
| Number of participants with infections |  | 6 weeks post surgery |