The Use of 3D Printing in Orbital Fractures
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | January 2020 |
| End Date: | September 2020 |
| Contact: | Dina Amin, DDS |
| Email: | dina.amin@emory.edu |
| Phone: | 404-251-8895 |
Does the Use of a Customized Titanium Reconstruction Plate for Orbital Fractures Result in Better Orbital Volume and Outcome
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).
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.
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.
We found this trial at
1
site
80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
Atlanta, Georgia 30303
(404) 616-1000
Principal Investigator: Dina Amin, MD
Phone: 404-251-8895
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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