Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

Minia University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post-Traumatic Orbital Deformity

Interventions

repair of orbital floor fractures using resorbable platesPROCEDURE

Eligibility

Sex: ALLMin age: 10 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: one month

Secondary Outcomes

improvement of symptoms

improvement of the patient complaints as diplopia and enophthalmos using questionnaire

Time frame: 6 to 12 months

Data from ClinicalTrials.gov

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