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Clinical Trials/NCT03683615
NCT03683615UnknownNot Applicable

Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

Minia University0 sites20 target enrollmentStarted: July 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
20
Primary Endpoint
anatomical reduction of the fracture
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
10 Years to 50 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Time Frame: one month

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

Secondary Outcomes

  • improvement of symptoms(6 to 12 months)

Investigators

Sponsor
Minia University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tamer Ismail Gawdat

clinical professor

Cairo University

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