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

February 13, 2020 updated by: Mohamed Salah, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Ahmed Mohamed, PhD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (ACTUAL)

February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMFS 3 3 10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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