NCT04218058

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 30, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

December 30, 2019

Last Update Submit

January 1, 2020

Conditions

Zygomatic Arch Reduction

Outcome Measures

Primary Outcomes (1)

  • zygomatic arch reduction

    to measure the amount of zygomatic arch reduction on postoperative ct scan and compare it with the normal side

    immediate post operative CT scan

Study Arms (2)

study (ultrasound guided closed reduction of zygomatic arch))

ACTIVE COMPARATOR

reduction of zygomatic arch guided by ultrasound

Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fracture

control (open reduction of zygomatic arch)

ACTIVE COMPARATOR

open reduction of zygomatic arch through coronal incision

Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fracture

Interventions

reduction of zygomatic arch in zygomaticomaxillary complex fracturePROCEDURE

ultrasound guided reduction of zygomatic arch

Also known as: open reduction of zygomatic arch in zygomaticomaxillary complex fracture
control (open reduction of zygomatic arch)study (ultrasound guided closed reduction of zygomatic arch))

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dentistry

Alexandria, 21500, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 6, 2020

Study Start

May 15, 2018

Primary Completion

September 25, 2019

Study Completion

November 23, 2019

Last Updated

January 6, 2020

Record last verified: 2020-01

Locations

EG(1)