Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures

January 1, 2020 updated by: Tasneem Ahmed Mabrouk Amer, Alexandria University

Ultrasound Guided Closed Reduction Versus Open Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures

To compare between ultrasound guided closed reduction and open reduction of zygomatic arch in cases of zygomaticomaxillary fracture.

To evaluate the role of intra-operative ultrasound during zygomatic arch reduction.

To compare between esthetic appearance, orbital movement, wound healing, scaring, and postoperative ocular complications in both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21500
        • Dentistry

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

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting with ZMC fractures that require reduction and fixation
  • Patients between 20 to 50 years old with no gender predilections

Exclusion Criteria:

  • Existence of infection at the fracture line
  • Chronic systemic diseases such as metabolic bone disease, immunocompromised status

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: study (ultrasound guided closed reduction of zygomatic arch))
reduction of zygomatic arch guided by ultrasound
Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fracture
ultrasound guided reduction of zygomatic arch
Other Names:
  • open reduction of zygomatic arch in zygomaticomaxillary complex fracture
ACTIVE_COMPARATOR: control (open reduction of zygomatic arch)
open reduction of zygomatic arch through coronal incision
Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fracture
ultrasound guided reduction of zygomatic arch
Other Names:
  • open reduction of zygomatic arch in zygomaticomaxillary complex fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
zygomatic arch reduction
Time Frame: immediate post operative CT scan
to measure the amount of zygomatic arch reduction on postoperative ct scan and compare it with the normal side
immediate post operative CT scan

Collaborators and Investigators

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

Sponsor

Alexandria 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)

May 15, 2018

Primary Completion (ACTUAL)

September 25, 2019

Study Completion (ACTUAL)

November 23, 2019

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

January 1, 2020

First Posted (ACTUAL)

January 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 6, 2020

Last Update Submitted That Met QC Criteria

January 1, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 0020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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