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
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
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
NCT ID
NCT04528264
First Posted
August 22, 2020
Last Updated
October 13, 2020
Sponsor
College of Medical Sciences Teaching Hospital. Nepal
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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