Correction of Enophthalmos and Orbital Volume Using Pre-bent Mesh Versus 3d Printed Onlay in Orbital Fracture Cases

Cairo University (CU)

Status: Unknown

Conditions: Enophthalmos; Orbital Fractures; Periorbital Fracture

Treatments: Combination Product: Pre-bent orbital mesh; Combination Product: 3D printed PEEK onlay

Study type: Interventional

Funder types: Other

Identifiers

NCT04271137

OMFS 3 3 10

Details and patient eligibility

About

this study evaluates the post-surgical correction of enophthalmos and orbital volume using 3D printed only versus pre-bent titanium mesh in blow-out fracture cases

Full description

Many materials had been used in reconstruction of blow out fractures, the aim of this study is to evaluate the enophthalmos correction and orbital volume restoration using 3D printed onlay versus pre-bent titanium mesh

Enrollment: 20 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (≤17 years old).
• Blow-out Orbital Fracture.
• Unilateral Orbital Trauma.
• Enophthalmos (≤ 2 mm).
• Patients with contralateral healthy, non-surgically operated orbit.

Exclusion criteria

• Young Patients (> 17 years old).
• Patients with Systemic diseases.
• Bilateral Orbital Trauma.
• Enophthalmos (>2 mm).
• Patients whom cannot tolerate follow up intervals.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Orbital fractues

Other group

Description:

Orbital fractures

Treatment:

Combination Product: 3D printed PEEK onlay

Combination Product: Pre-bent orbital mesh