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

Not Applicable

• Conditions: Orbital Fractures; Enophthalmos; Periorbital Fracture
• Interventions: Combination Product: 3D printed PEEK onlay; Combination Product: Pre-bent orbital mesh

• Registration Number: NCT04271137
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed 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

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-13
• Last Update Submitted: 2020-02-13
• Study First Posted: 2020-02-17
• Last Update Posted: 2020-02-17
• Study Start: 2020-03-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Orbital fractues	Pre-bent orbital mesh	Orbital fractures
Orbital fractues	3D printed PEEK onlay	Orbital fractures

Primary Outcome Measures

Name	Time	Method
Enophthalmos	1 year post-operative	CT based - corneal projection from lateral orbital rim measured in millimeters

Secondary Outcome Measures

Name	Time	Method
Orbital volume	one week post-operative	Change in orbital volume ratio on CT in centimeter cubic
Implant position accuracy	One week post-operative	Superimposition of pre- and post-operative 3d bony structures on CT in 2d views of the x-ray

Trial Locations

Locations (1)

Faculty of Dentistry - Cairo University; 🇪🇬 Cairo, Egypt