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Craniofacial Applications of 3D Printing

NCT03292679 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-04-03

No results posted yet for this study

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

Interventions

PROCEDURE

3D template

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03292679 on ClinicalTrials.gov