The Use of 3D Printing in Orbital Fractures
The Use of 3D Printing in Orbital Fractures
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).
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.
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.