Resorbable Polymer Plates in Repair of Blowout Orbital Fl... | NCT03683615

Studies
Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

NCT03683615

Sponsor

Minia University

Status

Unknown status

Last Update Posted

Sep 25, 2018Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Post-Traumatic Orbital Deformity

Interventions

repair of orbital floor fractures using resorbable plates

Countries

Not provided

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016Actual

Primary Completion Date

Jan 2019Estimated

Completion Date

Apr 2019Estimated

First Submitted Date

Sep 20, 2018

First Submission Date that Met QC Criteria

Sep 22, 2018

First Posted Date

Sep 25, 2018Actual

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

Sep 22, 2018

Last Update Posted Date

Sep 25, 2018Actual

Name	Class
Cairo University	OTHER

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

It is a prospective study to evaluate the use of resorbable plates for the repair of blow out orbital floor fractures over a follow up period of one year at both cosmetic and functional levels.

Detailed Description

Not provided

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
patients with traumatic recent orbital blow out fractures	Other		Procedure: repair of orbital floor fractures using resorbable plates

Interventions

Name	Type	Description	Arm Group Labels	Other Names
repair of orbital floor fractures using resorbable plates	Procedure		patients with traumatic recent orbital blow out fractures

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
anatomical reduction of the fracture	reduction of the fractured segment and restore the normal orbital volume and contents . assessment of reduction by measuring the changes in the orbital volume using computed tomography	one month

Secondary Outcomes

Measure	Description	Time Frame
improvement of symptoms	improvement of the patient complaints as diplopia and enophthalmos using questionnaire	6 to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Class I, II blowout floor fracture.
Presented within 2 weeks of trauma.
Have muscle or soft tissue distortion with clinically significant diplopia, enophthalmos or restrictive strabismus.

Exclusion Criteria:

Comminuted orbital fractures involving the rim.
Associated globe injuries.
Delayed presentation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

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