Craniofacial Applications of 3D Printing

Withdrawn before enrolling

Conditions studied: Facial Fracture

In brief

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.

Key facts

Study ID

NCT03292679

Run by

University of Maryland, Baltimore

People needed

0

Starts

2019-06-01

Expected to finish

2020-09-01

Last updated by the study team

2023-04-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Arthur J Nam — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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