Determining the Ease of Utilizing 3D Printed Models to Aide in Isolated Mandibular Fracture Repair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mandible Fracture
- Sponsor
- University of Cincinnati
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Total time in the OR
- Status
- Enrolling By Invitation
- Last Updated
- 11 months ago
Overview
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.
Investigators
Deepak Krishnan
Chief of Oral & Maxillofacial Surgery
University of Cincinnati
Eligibility Criteria
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
Outcomes
Primary Outcomes
Total time in the OR
Time Frame: Total procedural time
Time in the OR considered critical part of the procedure by the Oral \& Maxillofacial Surgery Staff
Subjective outcome to surgeon
Time Frame: 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.