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

Orbital Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04271137
• Other study ID #: OMFS 3 3 10
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2020
• Source: Cairo University
• Contact: Khalid Amr, PhD
• Phone: +201006029031
• Email: khaledamr82[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enophthalmos
• Fractures, Bone
• Orbital Fractures
• Periorbital Fracture

Intervention

Combination Product:
• 3D printed PEEK onlay
3d computer-designed Orbital onlay
• Pre-bent orbital mesh
Pre-bent orbital mesh on 3d printed template

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enophthalmos	CT based exphthalmometery - corneal projection from lateral orbital rim measured in millimeters	1 week post-operative
Primary	Enophthalmos	CT based - corneal projection from lateral orbital rim measured in millimeters	1 year post-operative
Secondary	Orbital volume	Change in orbital volume ratio on CT in centimeter cubic	one week post-operative
Secondary	Implant position accuracy	Superimposition of pre- and post-operative 3d bony structures on CT in 2d views of the x-ray	One week post-operative