Orbital Floor Fracture Repair by Titanium Mesh Via Transa... | NCT05439512

Studies
Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach.

NCT05439512

Sponsor

Cairo University

Status

Completed

Last Update Posted

Feb 7, 2024Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Orbital Fractures

Interventions

transantral orbital floor reconstruction by titanium 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 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Jun 5, 2023Actual

Completion Date

Jul 27, 2023Actual

First Submitted Date

Jun 26, 2022

First Submission Date that Met QC Criteria

Jun 26, 2022

First Posted Date

Jun 30, 2022Actual

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 5, 2024

Last Update Posted Date

Feb 7, 2024Actual

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

The aim of the study is to evaluate the feasibility of CAD/CAM osteosynthesis mesh through a transantral surgical approach in the Repair of orbital floor fractures by means of clinical and radiographic findings.

Detailed Description

A CAD/CAM osteosynthesis mesh through a transantral approach should assumingly provide accurate reconstruction of the orbital volume and anatomy while eliminating the usual morbidity of lower eyelid approaches during orbital reconstruction.

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

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
orbital floor fracture	Experimental	orbital floor fracture	Procedure: transantral orbital floor reconstruction by titanium mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transantral orbital floor reconstruction by titanium mesh	Procedure	reconstruction of orbital floor fracture by patient specific titanium mesh	orbital floor fracture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
enophthamus	will calculate the amount of alteration and quantity of Enophthalmos by mean of a Post-Op Soft window CT scan in mm	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with recent unilateral orbital floor fracture indicated for internal reconstruction -
(isolated or in combination with other facial fractures)
with existing or estimated enophthalmos based on radiographs and a contra-lateral healthy non-operated orbit.

Exclusion Criteria:

Delayed cases (more than 2 weeks)
previously operated cases
bilateral orbital floor fracture.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D009917	Orbital Fractures

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