Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03292679 |
| Other study ID # |
HP-00071854 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2019 |
| Est. completion date |
September 2020 |
Study information
| Verified date |
March 2023 |
| Source |
University of Maryland, Baltimore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
The purpose of this study is to:
1. produce 3D printed craniofacial models of patients with facial fracture, then use the 3D
models
2. contour (or pre-bend) the appropriate hardware pre-op that is specific for the patient.
Fracture repair in the operating room entails exposure and reduction of the fracture,
followed by contouring the hardware to the correct shape to maintain the fracture reduction.
However, in unstable or comminuted fractures or in patients missing several teeth, contouring
the plate to the correct shape can be time consuming and, sometimes, the plate shape can be
inaccurate. Our hypothesis is that using our own 3D model printed on-site to "pre-bend"
plates will save intra-operative time and cost, and achieve superior clinical outcome.
Patients will be enrolled to participate if they meet inclusion and exclusion criteria, and
provide informed consent.
Additionally, for study subjects, protected health information such as name, date of birth,
medical record number, and demographic information (age, sex, ethnic group), Billing and
payment information with medical justification, clinical information related to the procedure
and follow-up visits will be handled by research personnel for research purposes.
Otherwise, management of the study subjects will be essentially the same as for patients that
are not enrolled in the study. This includes CT scans obtained postoperatively to confirm
adequate fracture repair, routine clinic follow-up visits (during post-op week 1, week 4, 3
months, 6 months, and/or 1 year after surgery) and additional follow-up visits as may be
deemed necessary based on clinical status.
Prior experience of utilizing on-site 3D printing technology in facial reconstruction surgery
is limited. If a patient-specific plate is needed, then the plates must be made by commercial
manufacturers which usually takes days to produce, and is therefore not suited to treatment
of facial trauma.
Trauma plastic surgery division owns and operates a 3D printer. We have experience with CT
image processing and have made 3D models of patients facial skeleton (i.e. midface, mandible)
that were used as templates for repairing facial fractures.
Patients with complex facial injuries or defects require reconstruction using hardware to
restore facial contour and functional stability. In many complex facial reconstructions,
surgeons consult commercial companies for expertise in computer aided design and
manufacturing of patient-specific implants. The advantages of undergoing this process include
(1) in-depth anatomic analysis, (2) improved design of hardware leading to better surgical
outcome, and (3) shortened OR time. The disadvantages include length of time required for the
production of patient-specific implant (usually 3 to 7 days), and high cost: for example, a
mandible 3D model and associated patient-specific reconstruction plate is >$3000.
Three-dimensional printing is an actively evolving technology, especially in surgery. Design
modifications and improvement in extrusion technology have made 3D printing made this process
much more affordable and relatively easy. It is now possible for individuals (and surgeons!)
to generate these 3D models.
Repair of mandible fractures is especially challenging when the patient is edentulous
(missing several or all teeth) for several reasons including the smaller bulk of the
edentulous mandible, requiring larger reconstructive plates spanning a bigger section of the
jaw. Surgery generally takes longer for these patients when compared with non-edentulous
patients. A substantial portion of the lengthiness is due to time spent bending the plate.
The rationale for this IRB proposal is to explore the efficacy of 3D models of the patient's
fracture that are printed in house as aids for facial fracture reconstruction. We hypothesize
that reconstruction with the aid of the models will require shorter OR time, improve bony
fixation, without significant increase in overall cost of treatment.
