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Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

Primary Purpose

Post-Traumatic Orbital Deformity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
repair of orbital floor fractures using resorbable plates
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Orbital Deformity focused on measuring Resorbable, blow out fractures

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    patients with traumatic recent orbital blow out fractures

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    improvement of symptoms
    improvement of the patient complaints as diplopia and enophthalmos using questionnaire

    Full Information

    First Posted
    September 20, 2018
    Last Updated
    September 22, 2018
    Sponsor
    Minia University
    Collaborators
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03683615
    Brief Title
    Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures
    Official Title
    Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Minia University
    Collaborators
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Traumatic Orbital Deformity
    Keywords
    Resorbable, blow out fractures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with traumatic recent orbital blow out fractures
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    repair of orbital floor fractures using resorbable plates
    Primary Outcome Measure Information:
    Title
    anatomical reduction of the fracture
    Description
    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 Outcome Measure Information:
    Title
    improvement of symptoms
    Description
    improvement of the patient complaints as diplopia and enophthalmos using questionnaire
    Time Frame
    6 to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

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