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

Primary Purpose

Orbital Fractures, Enophthalmos, Periorbital Fracture

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

3D printed PEEK onlay

Pre-bent orbital mesh

About this trial

This is an interventional treatment trial for Orbital Fractures focused on measuring 3d printed onlay, PEEK, orbital mesh, computer-guided surgery

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Faculty of Dentistry - Cairo University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Orbital fractues

Arm Description

Orbital fractures

Outcomes

Primary Outcome Measures

Enophthalmos

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

Enophthalmos

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

Secondary Outcome Measures

Orbital volume

Change in orbital volume ratio on CT in centimeter cubic

Implant position accuracy

Superimposition of pre- and post-operative 3d bony structures on CT in 2d views of the x-ray

Full Information

NCT ID

NCT04271137

First Posted

February 10, 2020

Last Updated

February 13, 2020

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04271137

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2020 (Anticipated)

Primary Completion Date

January 1, 2021 (Anticipated)

Study Completion Date

March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orbital Fractures, Enophthalmos, Periorbital Fracture

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Orbital fractues

Arm Type

Other

Arm Description

Orbital fractures

Intervention Type

Combination Product

Intervention Name(s)

3D printed PEEK onlay

Intervention Description

3d computer-designed Orbital onlay

Intervention Type

Combination Product

Intervention Name(s)

Pre-bent orbital mesh

Intervention Description

Pre-bent orbital mesh on 3d printed template

Primary Outcome Measure Information:

Title

Enophthalmos

Description

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

Time Frame

1 week post-operative

Title

Enophthalmos

Description

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

Time Frame

1 year post-operative

Secondary Outcome Measure Information:

Title

Orbital volume

Description

Change in orbital volume ratio on CT in centimeter cubic

Time Frame

one week post-operative

Title

Implant position accuracy

Description

Superimposition of pre- and post-operative 3d bony structures on CT in 2d views of the x-ray

Time Frame

One week post-operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Khalid Amr, PhD

Phone

+201006029031

khaledamr82@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Mohamed, PhD

Organizational Affiliation

Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry - Cairo University

City

Cairo

ZIP/Postal Code

11553

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Khalid Amr, PhD

khaledamr82@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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