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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04271137
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):
Mohamed Salah, Cairo University

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Enophthalmos [ Time Frame: 1 week post-operative ]
    CT based exphthalmometery - corneal projection from lateral orbital rim measured in millimeters

  2. Enophthalmos [ Time Frame: 1 year post-operative ]
    CT based - corneal projection from lateral orbital rim measured in millimeters

Secondary Outcome Measures :
  1. Orbital volume [ Time Frame: one week post-operative ]
    Change in orbital volume ratio on CT in centimeter cubic

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04271137

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Contact: Khalid Amr, PhD +201006029031

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Faculty of Dentistry - Cairo University
Cairo, Egypt, 11553
Contact: Khalid Amr, PhD   
Sponsors and Collaborators
Cairo University
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Study Director: Ahmed Mohamed, PhD Cairo University
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Responsible Party: Mohamed Salah, Principal investigator, Cairo University Identifier: NCT04271137    
Other Study ID Numbers: OMFS 3 3 10
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Salah, Cairo University:
3d printed onlay
orbital mesh
computer-guided surgery
Additional relevant MeSH terms:
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Orbital Fractures
Fractures, Bone
Wounds and Injuries
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures
Orbital Diseases
Eye Diseases