Ultrasound Guided Closed Reduction of Depressed Zygomatic Arch Fractures

NCT04528264 | Unknown DMC

• 1 other identifier: CMSNepal
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

zygomatic arch fracture; Intraoperative Imaging; guided reduction

Outcome Measures

Primary Outcomes (4)

• Post operative radiographic evidence of adequate reduction

  The radiographic evaluation will be performed blinded by one of the clinician oral and maxillofacial surgeons who will not be involved in any of the operations. The adequacy of reduction will be evaluated in a DICOM viewing software on axial scans to assess contour of the arch and step if any at the fracture site. 1. Good reduction : Absence of any step and straight contour of zygomatic arch symmetric to contralateral uninjured arch 2. Average reduction: Absence of any step but poor contour of zygomatic arch and asymmetric to contralateral uninjured arch 3. Poor reduction: Presence of both a cortical step and asymmetric arch compared to contralateral uninjured arch

  24 hours

• Facial profile symmetry

  Clinical assessment will be performed blinded by a clinician oral and maxillofacial surgeon who will not be involved in any of the operations on first postoperative day, first follow up visit after one week of operation and 4 weeks of operation. Facial symmetry and projection will be assessed clinically by the clinician and graded as good, adequate and poor. A patient oriented clinical outcome is considered good practice and clinically relevant in modern evidence based medicine so patient response will be recorded as binary (yes/no) response regarding their view on facial symmetry.

  one week to four weeks

• Number of reoperations

  Revision surgery required after failed reduction assessed and confirmed radiographically on CT scan and clinical assessment as well as patient reported measure of facial symmetry and adequate mouth opening.

  24 hours

• Mouth opening

  Interincisal opening measured between the incisal tips of central incisor teeth and recorded in millimeter using a vernier caliper.

  at 24 hours postoperatively

Secondary Outcomes (3)

• Operative time

  Intraoperative

• Number of attempts or reduction

  Intraoperative

• Cost of intervention

  Intraoperative

Study Arms (2)

Ultrasound guided

EXPERIMENTAL

Intraoperative high frequency ultrasound used to guide the reduction of depressed zygomatic arch.

Device: Intraoperative ultrasound guided

Conventional blind reduction technique

OTHER

Conventional blind reduction of zygomatic arch fracture will be conducted without any intraoperative imaging.

Other: Conventional blind reduction technique

Interventions

Intraoperative ultrasound guided DEVICE

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.

Also known as: Intraoperative USG Imaging

Ultrasound guided

Conventional blind reduction technique OTHER

Conventional blind reduction technique

Also known as: comparator

Conventional blind reduction technique

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years and above
• fractured and depressed zygomatic arch requiring surgical reduction

You may not qualify if:

• pregnant patients
• not willing for participation
• below 6 years age

Sponsors & Collaborators

• College of Medical Sciences Teaching Hospital. Nepal: lead

Related Links

• Project page on Researchgate

Study Officials

• Ashutosh K Singh, MDS

  College of Medical Sciences, Nepal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashutosh K Singh, MDS

CONTACT

+9779804244369; dr.ashutosh@cmsnepal.edu.np

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sealed Envelope will be used to conceal allocation. Patients will be unaware of their group allocation. Outcome assessor will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized double blind

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 27, 2020
• Study Start: June 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: August 1, 2022
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after completion and publication
• Access Criteria: Decided by PI