Mandible Fracture, Maxillofacial Trauma
Conditions
Keywords
3D Printing, Personalized Medicine, Maxillofacial Trauma
Brief summary
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
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.
Interventions
DEVICE3D Printed Model
3D Printed Model generated pre-operatively of the patients mandible.
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Once the subjects are identified the research coordinator will conduct a screening of the patient to ensure they meet the inclusion/ exclusion criteria for the study and then randomize the patient into either normal standard of care for surgical repair of the fractured mandible or normal standard of care for surgical repair of the fractured mandible aided by a 3D printed model of the patient's jaw.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total time in the OR | Total procedural time | Time in the OR considered critical part of the procedure by the Oral \& Maxillofacial Surgery Staff |
| Subjective outcome to surgeon | Up to 2 days post-procedure | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeepak G Krishnan, DDS
University of Cincinnati
Outcome results
None listed