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

Evaluation of Orbital Reconstruction Using Patient Specific 3-D Printed Onlay Versus Pre-Bent Titanium Mesh

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04271137

Enrollment

Registered

2020-02-17

Start date

2020-03-01

Completion date

2021-03-01

Last updated

2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enophthalmos, Orbital Fractures, Periorbital Fracture

Keywords

3d printed onlay, PEEK, orbital mesh, computer-guided surgery

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

Interventions

COMBINATION_PRODUCT3D printed PEEK onlay

3d computer-designed Orbital onlay

COMBINATION_PRODUCTPre-bent orbital mesh

Pre-bent orbital mesh on 3d printed template

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Enophthalmos	1 week post-operative	CT based exphthalmometery - corneal projection from lateral orbital rim measured in millimeters

Secondary

Measure	Time frame	Description
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

Countries

Egypt

Contacts

Primary ContactKhalid Amr, PhD

khaledamr82@gmail.com+201006029031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026