Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures

Phase 1

Completed

• Conditions: Zygomatic Arch Reduction
• Interventions: Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fracture

• Registration Number: NCT04218058
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-15
• Primary Completion: 2019-09-25
• Study Completion: 2019-11-23
• Study First Submitted: 2019-12-30
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-01
• Last Update Submitted: 2020-01-01
• Study First Posted: 2020-01-06
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study (ultrasound guided closed reduction of zygomatic arch))	reduction of zygomatic arch in zygomaticomaxillary complex fracture	reduction of zygomatic arch guided by ultrasound
control (open reduction of zygomatic arch)	reduction of zygomatic arch in zygomaticomaxillary complex fracture	open reduction of zygomatic arch through coronal incision

Primary Outcome Measures

Name	Time	Method
zygomatic arch reduction	immediate post operative CT scan	to measure the amount of zygomatic arch reduction on postoperative ct scan and compare it with the normal side

Trial Locations

Locations (1)

Dentistry; 🇪🇬 Alexandria, Egypt