Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

September 22, 2018 updated by: Tamer Ismail Gawdat, Minia University
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patients with traumatic recent orbital blow out fractures
Procedure: repair of orbital floor fractures using resorbable plates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Collaborators

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 22, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 22, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16111985

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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