Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique

April 5, 2021 updated by: Ahmed Morad
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures reduction Using Patient Specific Guide (PSG) Versus Conventional Technique

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Zygomatic Fracture Type III, IV and V according to rowe and killey classification(13)

    • Age (18-60 years)
    • Recent fracture (less than 2 weeks)

Exclusion Criteria:

  • • Zygomatic Fracture Type I, II and VI according to rowe and killey classification(13)

    • Medical compromised patient
    • Patient on radiotherapy
    • Bone disease

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (ZMC) Fractures reduction Using Patient Specific Guide (PSG)
Procedure: patient specific guide
patient specific guide reduction
Active Comparator: (ZMC) Fractures reduction Using Conventional Technique
Procedure: conventional technique
conventional anatomical reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of reduction of the fractured zygoma ( facial asymetry )
Time Frame: up to 6 months
assessed by ct
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: up to 6 months
in hours
up to 6 months

Collaborators and Investigators

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

Sponsor

Ahmed Morad

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 (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Omfs 3.3.10

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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