Craniofacial Applications of 3D Printing

NCT03292679 | Withdrawn

• 1 other identifier: HP-00071854
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

3D printing is a technology that allows for physical creation of a 3D model (usually made of plastic) based on computer generated 3D images from CT scans. The 3D images of craniofacial skeleton using computer software are routinely generated and, in turn, these 3D images can be used to create a plastic 3D model using a 3D printer. Unstable or comminuted facial fractures need to be reduced and rigidly fixated using titanium plates and screws. Bending and shaping of the plates is usually performed by free-hand based on the surgeon's estimation of what best fits the fracture. Often, bending the titanium plates to the shape of pre-injury skeletal contour is difficult when the bone is fractured into many pieces or is unstable, or when the patient is edentulous (missing several teeth). The process can increase the time spent in surgery and the bent plates may not snugly fit the fracture. For these difficult cases, one option is to use commercially manufactured 3D printed patient-specific models. The patient-specific models provide the benefit of correct shape / form for increased surgical accuracy, and decreased intra-operative time. However these commercial models are manufactured at distant facilities and usually require more than 7 days before delivery. As such, they delay time to surgery and cannot be used for urgent surgery. Additionally, the commercially manufactured implants are expensive, significantly increasing the cost of treatment. The purpose of this study is to explore whether custom plastic models 3D printed at Shock Trauma Center and used for bending and shaping plates for facial fracture repair can improve results of facial fracture reconstruction. Our plastic surgery division will design and produce facial bone 3D model of patients (with facial fractures) using an in-house 3D printer, then use the 3D model to contour the hardware pre-op or intra-op at the time of fracture repair. We believe that we can achieve better repair, shorter surgery time, and save hardware cost.

Conditions

Facial Fracture

Outcome Measures

Primary Outcomes (1)

• Operative time

  Duration of fracture fixation

  24 hours

Study Arms (1)

3D template

Subjects will have custom models of relevant portions of their facial skeleton printed and used as templates for bending and shaping plates for stabilizing the fracture(s).

Procedure: 3D template

Interventions

3D template PROCEDURE

A 3D-printed model of relevant portions of the patient's facial skeleton, based on patient's CT scan will be created. This model will be used to bend titanium reconstruction plates that are used to stabilize the facial fracture for subjects in the treatment group. Bending of the plates will be performed in the operating room during the patient's surgery. Titanium reconstruction plates are used to stabilize the fracture whether or not the individual is in the study. However, for patients that are in the treatment arm of the study, the plates are bent with the aid of the 3D-printed model as template, rather than by free-hand.

3D template

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting to Shock Trauma Plastic Surgery Division for treatment of facial fractures

You may qualify if:

• Patients with face CT scans
• Patients with facial fractures
• Patient age 12 years or older

You may not qualify if:

• Patients without CT scan
• Patients with facial fractures that do not require rigid fixation using hardware
• Patients with facial fractures that do not have normal contralateral bony structures
• Patient age less than 12 years

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Arthur J Nam

Baltimore, Maryland, 21201, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: June 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

US (1)