Correction of Enophthalmos and Orbital Volume Using Pre-b... | NCT04271137

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

NCT04271137

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 17, 2020Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Orbital Fractures
Enophthalmos
Periorbital Fracture

Interventions

3D printed PEEK onlay
Pre-bent orbital mesh

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Estimated

Primary Completion Date

Jan 1, 2021Estimated

Completion Date

Mar 1, 2021Estimated

First Submitted Date

Feb 10, 2020

First Submission Date that Met QC Criteria

Feb 13, 2020

First Posted Date

Feb 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2020

Last Update Posted Date

Feb 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orbital fractues	Other	Orbital fractures	Combination Product: 3D printed PEEK onlay Combination Product: Pre-bent orbital mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D printed PEEK onlay	Combination Product	3d computer-designed Orbital onlay	Orbital fractues

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Khalid Amr, PhD	Contact	+201006029031		khaledamr82@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmed Mohamed, PhD	Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry - Cairo University		Cairo		11553	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D009917	Orbital Fractures
D015841	Enophthalmos

Ancestor Terms

ID	Term
D008446	Maxillofacial Injuries
D005151	Facial Injuries
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided