Clinical trial NCT03673865: The Use of 3D Printing in Orbital Fractures
Official title: Does the Use of a Customized Titanium Reconstruction Plate for Orbital Fractures Result in Better Orbital Volume and Outcome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Orbital Fractures
Keywords: 3D Printer
orbital implants
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized clinical study with longitudinal follow-up
Primary purpose: TREATMENT

Brief summary: The study is a prospective randomized longitudinal clinical study to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants (the latter being the traditional approach and current standard of care).

Detailed description: Orbital fracture, which accounts for 10-25% of facial fractures, is one of the most difficult facial fractures to treat. The complex bone anatomy and the proximity of adjacent vital structures make reconstruction of these fractures challenging. Inadequate orbital fracture reconstruction leads to cosmetic and functional complications. Cosmetic complications include enophthalmos, which is defined as posterior displacement of the eyeball within the orbit due to changes in the volume of the orbit (bone) relative to its contents (the eyeball and orbital fat). Functional complications include diplopia, defined as a type of vision disorder in which two images are seen of a single object.

This is a prospective randomized clinical study with longitudinal follow-up. The study duration is 2 years, and it will be conducted at Grady Memorial Hospital (GMH). The study targets low-income, urban adults suffering blunt facial trauma who are diagnosed with unilateral orbital fracture.

The purpose of this study is to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants. Main aims of the study are to 1) preoperatively generate a patient-specific model to pre-adapt the titanium mesh for use in unilateral orbital fractures; 2) accurately restore the orbital volume to pre-injury levels; 3) prevent postoperative complications including enophthalmos and diplopia; and 4) decrease the operative time, therefore decreasing overall cost and increasing value.

Eligibility criteria: Inclusion Criteria:

* Agreed to be enrolled in the study.
* Indications for surgical repair of orbital floor and/ wall fractures are dependent on several factors:

  * Correction or prevention of cosmetic deformity ( enophthalmos or inferior dystopia; disruption of greater than 50% of the orbital floor is likely to cause cosmetically apparent enophthalmos.
  * Correction of unresolved diplopia (7 to 11 days) in the sitting of soft tissue prolapse with a positive forced duction test.
  * Immediate correction of diplopia in the sitting inferior rectus muscle incarceration and a positive forced duction test.
  * Immediate correction in a symptomatic patient with orbital floor ( trapdoor) fracture that has elicited the oculocardiac reflex.
* At least 18 years of age.
* Unilateral orbital floor fracture.
* No history of orbital trauma.
* Healthy contralateral orbit.
* Underwent orbital reconstruction.
* Admitted to GMH.
* Returned for the 6-week follow-up.

Exclusion Criteria:

* Refuse study enrollment.
* Are younger than 18 years.
* Pregnant women.
* Prisoner
* Unable to obtain consent (cognitively impaired)
* Are admitted to hospitals other than Grady Memorial Hospital.

Primary outcomes:
measure: Orbital Volume of the Injured Orbit Compared to the Contralateral Uninjured Orbit as Assessed by CT Scan Between the Treatment and Control Groups
timeFrame: 1 hour post operatively
Secondary outcomes:
measure: Number of Subjects With Reduction of Orbital Volume to Less Than 2 cm3 Between the Treatment and Control Groups
timeFrame: 1 week, 3 weeks, and 6 weeks postoperatively.
measure: Number of Subjects With a Difference of More Than 2 mm Between the Two Orbits Between the Treatment and Control Groups
timeFrame: 1 week, 3 weeks, and 6 weeks postoperatively.
measure: Number of Subjects With Infection Between the Treatment and Control Groups
timeFrame: 1 week, 3 weeks, and 6 weeks postoperatively.
measure: Number of Subjects With Infraorbital Nerve Injury Between the Treatment and Control Groups
timeFrame: 1 week, 3 weeks, and 6 weeks postoperatively.
measure: Number of Subjects With Intraocular Pressure (IOP) > 40 mmHg Between the Treatment and Control Groups
timeFrame: 1 week, 3 weeks, and 6 weeks postoperatively.
measure: Mean Operating Time in Minutes Between the Treatment and Control Groups
timeFrame: Intraoperative time period
measure: Mean Length of Stay in Hospital Measured in Days Between the Treatment and Control Groups
timeFrame: up to 2 weeks
measure: Mean Treatment Amount in Dollars Between the Treatment and Control Groups
timeFrame: up to 2 weeks
measure: Number of Subjects That Develop Restricted Extraocular Motility That Was Not Present Before Between the Treatment and Control Groups
timeFrame: 1 week, 3 weeks, and 6 weeks postoperatively.
measure: Number of Subjects With Inability to Achieve the Normal Orbital Contour Between the Treatment and Control Groups
timeFrame: Up to 6 hours postoperatively
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Dina Amin, DDS
role: PRINCIPAL_INVESTIGATOR
References: