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Ultrasound Guided Closed Reduction of Depressed Zygomatic Arch Fractures

NCT04528264 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-10-14

No results posted yet for this study

Summary

Zygomatic arch fractures have always been treated with blind closed reduction and is the most commonly used method. Blind reduction of fractures might lead to inadequate reduction and associated complications of facial asymmetry and limitations in mouth opening which may require reoperation for correction. Various methods like portable CT scan, C arm fluoroscopy, endoscopy and ultrasound have been proposed and used to visualize the reduction for better outcome. Out of these, ultrasound is inexpensive, easily available, easy to use, non-ionizing and has greatest potential to be used as standard for visual reduction of zygomatic arch fractures. There are studies where ultrasound has been compared to blind method and other modalities but level I evidence and recommended protocol for its intraoperative use has been lacking.

Conditions

  • Zygomatic Arch Fracture

Interventions

DEVICE

Intraoperative ultrasound guided

Samsung Mysono U6 machine with LN 15 linear (https://www.samsunghealthcare.com/en/products/UltrasoundSystem/MySono%20U6/General%20Imaging/transducers) probe capable of Musculoskeletal imaging will be used for visualization and location of fracture after which elevation and reduction of fracture will be attempted. The ultrasound probe will be used as described by McCann. Radiographic continuity of periosteal shadow without any step will be taken as end point for reduction and the procedure will be terminated.

OTHER

Conventional blind reduction technique

Conventional blind reduction technique

Sponsors & Collaborators

  • College of Medical Sciences Teaching Hospital. Nepal

    lead OTHER

Principal Investigators

  • Ashutosh K Singh, MDS · College of Medical Sciences, Nepal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2021-10-31
Completion
2022-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04528264 on ClinicalTrials.gov