The Use of 3D Printing in Orbital Fractures

Emory University

Status: Terminated

Conditions: Orbital Fractures

Treatments: Device: standard stock orbital plate; Device: office-based 3-dimensional printers (OB3DP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03673865

IRB00103655

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)

Treatment:

Device: office-based 3-dimensional printers (OB3DP)

Control Group

Active Comparator group

Description:

Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate

Treatment:

Device: standard stock orbital plate