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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04271137
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Orbital Fractures; Enophthalmos; Periorbital Fracture	Combination Product: 3D printed PEEK onlay; Combination Product: Pre-bent orbital mesh	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Orbital Reconstruction Using Patient Specific 3-D Printed Onlay Versus Pre-Bent Titanium Mesh
• Anticipated Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2021
• Anticipated Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Orbital fractues Orbital fractures	Combination Product: 3D printed PEEK onlay; 3d computer-designed Orbital onlay; Combination Product: Pre-bent orbital mesh; Pre-bent orbital mesh on 3d printed template

Outcome Measures

Primary Outcome Measures

1. Enophthalmos [1 week post-operative]

   CT based exphthalmometery - corneal projection from lateral orbital rim measured in millimeters

2. Enophthalmos [1 year post-operative]

   CT based - corneal projection from lateral orbital rim measured in millimeters

Secondary Outcome Measures

1. Orbital volume [one week post-operative]

   Change in orbital volume ratio on CT in centimeter cubic

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry - Cairo University	Cairo		Egypt	11553

Sponsors and Collaborators

• Cairo University

Investigators

• Study Director: Ahmed Mohamed, PhD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Salah, Principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT04271137
• Other Study ID Numbers: OMFS 3 3 10
• First Posted: Feb 17, 2020
• Last Update Posted: Feb 17, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed Salah, Principal investigator, Cairo University: 3d printed onlay; PEEK; orbital mesh; computer-guided surgery
• Additional relevant MeSH terms: Orbital Fractures; Enophthalmos; Fractures, Bone

Study Results

No Results Posted as of Feb 17, 2020