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Ultrasound Guided Closed Reduction of Depressed Zygomatic Arch Fractures

Primary Purpose

Zygomatic Arch Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intraoperative ultrasound guided
Conventional blind reduction technique
Sponsored by
College of Medical Sciences Teaching Hospital. Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Zygomatic Arch Fracture focused on measuring zygomatic arch fracture, Intraoperative Imaging, guided reduction

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Ultrasound guided

    Conventional blind reduction technique

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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. Good reduction : Absence of any step and straight contour of zygomatic arch symmetric to contralateral uninjured arch Average reduction: Absence of any step but poor contour of zygomatic arch and asymmetric to contralateral uninjured arch Poor reduction: Presence of both a cortical step and asymmetric arch compared to contralateral uninjured arch
    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.
    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.
    Mouth opening
    Interincisal opening measured between the incisal tips of central incisor teeth and recorded in millimeter using a vernier caliper.

    Secondary Outcome Measures

    Operative time
    Additional time required to reduce with intervention.
    Number of attempts or reduction
    Additional attempts required with imaging guidance.
    Cost of intervention
    Additional cost required with imaging guidance.

    Full Information

    First Posted
    August 22, 2020
    Last Updated
    October 13, 2020
    Sponsor
    College of Medical Sciences Teaching Hospital. Nepal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04528264
    Brief Title
    Ultrasound Guided Closed Reduction of Depressed Zygomatic Arch Fractures
    Official Title
    Ultrasound Guided Closed Reduction of Depressed Zygomatic Arch Fractures Compared to Conventional Blind Reduction: A Randomized Double Blind Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    October 2021 (Anticipated)
    Study Completion Date
    August 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    College of Medical Sciences Teaching Hospital. Nepal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Isolated and depressed zygomatic arch fractures have an incidence of about 5 to 14% of lateral mid face fractures. Depressed zygomatic arch fractures have been managed by blind closed reduction historically based upon tactile sense of surgeon and auditory click assumed as the conclusive evidence of reduction. The minimal fracture exposure for zygomatic arch fractures either solitary or combined with zygomaticomaxillary complex fractures results in inadequate visibility of the fractures and inadequate or inappropriate reduction of fractures. These fractures can be visualized by surgical exposure with coronal approach but is limited by complications and extensive training required. Other options are intraoperative imaging with portable CT scan but they are cumbersome, require radiologists for positioning and are not available in all operative units as well as expensive. Endoscopic visualization and reduction are another option for intraoperative control of these fractures but endoscopes are expensive, not available in all operative units and require experience and training to use appropriately. Various studies and our own experience show that unacceptable number of depressed zygomatic arch fractures remain incompletely reduced with blind reduction method. The resulting deficit might be as small as a depressed lateral face, inadequate sagittal projection of cheek to inadequate mouth opening. Portable ultrasound machines are readily available in almost all anesthesia units and operating rooms. These ultrasound units can be utilized to reduce the zygomatic arch satisfactorily with real time image guidance and it has advantage of being radiation free and inexpensive compared to fluoroscopy based portable C arm units. A small pilot in our own unit has shown remarkable difference between reduction achieved under ultrasonography guidance vs closed reduction based on tactility. This method should be explored and perfected to bring in common use among Oral & Maxillofacial surgeons so that blind assumption of fracture reduction is replaced by a more scientific confirmation of fracture reduction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Zygomatic Arch Fracture
    Keywords
    zygomatic arch fracture, Intraoperative Imaging, guided reduction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized double blind
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound guided
    Arm Type
    Experimental
    Arm Description
    Intraoperative high frequency ultrasound used to guide the reduction of depressed zygomatic arch.
    Arm Title
    Conventional blind reduction technique
    Arm Type
    Other
    Arm Description
    Conventional blind reduction of zygomatic arch fracture will be conducted without any intraoperative imaging.
    Intervention Type
    Device
    Intervention Name(s)
    Intraoperative ultrasound guided
    Other Intervention Name(s)
    Intraoperative USG Imaging
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional blind reduction technique
    Other Intervention Name(s)
    comparator
    Intervention Description
    Conventional blind reduction technique
    Primary Outcome Measure Information:
    Title
    Post operative radiographic evidence of adequate reduction
    Description
    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. Good reduction : Absence of any step and straight contour of zygomatic arch symmetric to contralateral uninjured arch Average reduction: Absence of any step but poor contour of zygomatic arch and asymmetric to contralateral uninjured arch Poor reduction: Presence of both a cortical step and asymmetric arch compared to contralateral uninjured arch
    Time Frame
    24 hours
    Title
    Facial profile symmetry
    Description
    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.
    Time Frame
    one week to four weeks
    Title
    Number of reoperations
    Description
    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.
    Time Frame
    24 hours
    Title
    Mouth opening
    Description
    Interincisal opening measured between the incisal tips of central incisor teeth and recorded in millimeter using a vernier caliper.
    Time Frame
    at 24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Operative time
    Description
    Additional time required to reduce with intervention.
    Time Frame
    Intraoperative
    Title
    Number of attempts or reduction
    Description
    Additional attempts required with imaging guidance.
    Time Frame
    Intraoperative
    Title
    Cost of intervention
    Description
    Additional cost required with imaging guidance.
    Time Frame
    Intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 6 years and above fractured and depressed zygomatic arch requiring surgical reduction Exclusion Criteria: pregnant patients not willing for participation below 6 years age
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashutosh K Singh, MDS
    Phone
    +9779804244369
    Email
    dr.ashutosh@cmsnepal.edu.np
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashutosh K Singh, MDS
    Organizational Affiliation
    College of Medical Sciences, Nepal
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Fully sharable link will be provided after study completion with deidentified data
    IPD Sharing Time Frame
    6 months after completion and publication
    IPD Sharing Access Criteria
    Decided by PI
    IPD Sharing URL
    https://www.researchgate.net/project/USG-guided-closed-reduction-of-depressed-zygomatic-arch-fractures

    Learn more about this trial

    Ultrasound Guided Closed Reduction of Depressed Zygomatic Arch Fractures

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