Mandible Fracture Clinical Trial
Official title:
Determining the Ease of Utilizing 3D Printed Models to Aide in Isolated Mandibular Fracture Repair
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | April 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UC Health Holmes Hospital | Cincinnati | Ohio |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati |
United States,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total time in the OR | Time in the OR considered critical part of the procedure by the Oral & Maxillofacial Surgery Staff | Total procedural time | |
Primary | 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 |
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