Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

NCT ID: NCT03683615

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-04-30

Brief Summary

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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

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Conditions

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Post-Traumatic Orbital Deformity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients with traumatic recent orbital blow out fractures

Group Type OTHER

repair of orbital floor fractures using resorbable plates

Intervention Type PROCEDURE

Interventions

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repair of orbital floor fractures using resorbable plates

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Minia University

OTHER

Sponsor Role lead

Responsible Party

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Tamer Ismail Gawdat

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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16111985

Identifier Type: -

Identifier Source: org_study_id

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