NCT04271137

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

February 10, 2020

Last Update Submit

February 13, 2020

Conditions

Orbital FracturesEnophthalmosPeriorbital Fracture

Keywords

3d printed onlayPEEKorbital meshcomputer-guided surgery

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Orbital volume

    one week post-operative

  • Implant position accuracy

    One week post-operative

Study Arms (1)

Orbital fractues

OTHER

Orbital fractures

Combination Product: 3D printed PEEK onlayCombination Product: Pre-bent orbital mesh

Interventions

3D printed PEEK onlayCOMBINATION_PRODUCT

3d computer-designed Orbital onlay

Orbital fractues
Pre-bent orbital meshCOMBINATION_PRODUCT

Pre-bent orbital mesh on 3d printed template

Orbital fractues

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≤17 years old).
  • Blow-out Orbital Fracture.
  • Unilateral Orbital Trauma.
  • Enophthalmos (≤ 2 mm).
  • Patients with contralateral healthy, non-surgically operated orbit.

You may not qualify if:

  • Young Patients (\> 17 years old).
  • Patients with Systemic diseases.
  • Bilateral Orbital Trauma.
  • Enophthalmos (\>2 mm).
  • Patients whom cannot tolerate follow up intervals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, 11553, Egypt

Location

MeSH Terms

Conditions

Orbital FracturesEnophthalmos

Condition Hierarchy (Ancestors)

Maxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and InjuriesOrbital DiseasesEye Diseases

Study Officials

  • Ahmed Mohamed, PhD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Khalid Amr, PhD

CONTACT

+201006029031khaledamr82@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 17, 2020

Study Start

March 1, 2020

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

EG(1)