3D Printed Models for Mandibular Fracture Repair

Not Applicable

• Conditions: Mandible Fracture; Maxillofacial Trauma
• Interventions: Device: 3D Printed Model

• Registration Number: NCT05733221
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-17
• Study Start: 2023-03-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D Model Generated	3D Printed Model	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

UC Health Holmes Hospital; 🇺🇸 Cincinnati, Ohio, United States