3D Printed Models for Mandibular Fracture Repair

Study Overview
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Brief Summary
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The investigators will test the hypothesis that patients randomized to the intervention (3D printing with pre-bent plate) arm have less operative room time and less time for the critical part of the procedure than patients in the control arm (no 3D printing, current standards of care). Personalized medicine and care for fracture treatment.

Detailed Description
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The goal of treatment is to re-establish the patient's preinjury dental occlusion and facial harmony. Fractures that are nondisplaced and exhibit no occlusal changes may be amenable to nonsurgical management, but most mandible fractures will require stabilization for satisfactory healing and to restore pretraumatic maxillomandibular orientation. Various treatment strategies have been described and vary widely depending on the fracture location and surgeon's preference. The patient's demographics, comorbidities, dentition, and fracture characterization will all influence the choice of fixation by the treating surgeon. There are very few randomized control trials that show outcomes when 3D printing is used for intervention planning and performing a procedure. These data are essential to establish value of 3D printing as a clinical service. There is also anecdotal evidence that a 3D printed model of a mandible fracture can be useful for pre-operative planning because the oral and maxillofacial surgeon can better assess the geometry of the bone lesions and can pre-bend fixation plates before the procedure. This hypothetically decreases the amount of time in the operating room. The investigators propose a parallel design randomized control trial to study the value of 3D printing for preoperative planning in patients with a fracture of the mandible who require open reduction, internal fixation. The study will be split into two arms: 1) Patients that will have a 3D model generated for the surgical procedure 2) The control group who will follow normal standards of care as outlined above and won't have the additional 3D model created pre-operatively.

Official Title
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Determining the Ease of Utilizing 3D Printed Models to Aide in Isolated Mandibular Fracture Repair

Conditions
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Mandible Fracture, Maxillofacial Trauma

Intervention / Treatment
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* Device: 3D Printed Model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥ 18 years of age Patients who have received either a cone beam or conventional CT Admitted through University of Cincinnati Hospital and Medical Center emergency department All isolated mandible fractures referred to University of Cincinnati Hospital Oral & maxillofacial surgery clinic Surgical team members from the division of plastic and otolaryngology Exclusion Criteria: Patient < 18 years of age Patients who have neither cone beam nor conventional CT Patients requiring a repeat procedure Unexpected exposure of hardware

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: The investigators propose a parallel design randomized control trial to study the value of 3D printing for preoperative planning in patients with a fracture of the mandible who require open reduction, internal fixation. The study will be split into two arms: 1) Patients that will have a 3D model generated for the surgical procedure 2) The control group who will follow normal standards of care as outlined above and won't have the additional 3D model created pre-operatively.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D Model Generated<br>Patient will undergo an Open Reduction and Internal Fixation preformed by a surgeon who had pre-operative access to a 3D model printed to help pre-bend hardware. | Device: 3D Printed Model<br>* 3D Printed Model generated pre-operatively of the patients mandible.<br>|
| No Intervention: Normal Standards of Care without Aide of Model<br>Patient will undergo standard Open Reduction and Internal Fixation by a surgeon who did not have a pre-operative 3D model. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time in the OR | Time in the OR considered critical part of the procedure by the Oral & Maxillofacial Surgery Staff | Total procedural time | 
| Subjective outcome to surgeon | Surgeon overall satisfaction with utilizing the 3D generated model, obtained via Likert Scale Questions completed post-operatively. The investigators are going to use the Likert questions to develop a numerical scoring system and report that data as raw Likert scores. Likert questions and conversion of specialists' responses to Anatomic Model Utility Points (AMUPs). Responses of strongly disagree, disagree, and neutral were assigned 0 AMUP points. Responses to preprocedural confidence are assigned negative points, to effectively subtract the impact of the anatomic model post- versus pre-procedure. The maximum AMUP for each patient was 500. | Up to 2 days post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D Printing, Personalized Medicine, Maxillofacial Trauma