Zygomatic Arch FractureNCT04528264
Ultrasound Guided Closed Reduction of Depressed Zygomatic Arch Fractures
A study testing Intraoperative ultrasound guided and Conventional blind reduction technique in people with Zygomatic Arch Fracture, run by College of Medical Sciences Teaching Hospital. Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Zygomatic Arch Fracture
- What is being tested?
- Intraoperative ultrasound guided and Conventional blind reduction technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 6 years and above
- fractured and depressed zygomatic arch requiring surgical reduction
Who cannot join
- pregnant patients
- not willing for participation
- below 6 years age
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Guided Closed Reduction of Depressed Zygomatic Arch Fractures Compared to Conventional Blind Reduction: A Randomized Double Blind Clinical Trial
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.
Read the 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.
- Conditions
- Zygomatic Arch Fracture
- Being tested
- Intraoperative ultrasound guided, Conventional blind reduction technique
- Keywords
- zygomatic arch fracture, Intraoperative Imaging, guided reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative ultrasound guidedDevice
Also called Intraoperative USG Imaging
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.
Conventional blind reduction techniqueOther
Also called comparator
Conventional blind reduction technique
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided | Experimental | Intraoperative high frequency ultrasound used to guide the reduction of depressed zygomatic arch. Receives: Device: Intraoperative ultrasound guided |
| Conventional blind reduction technique | Other | Conventional blind reduction of zygomatic arch fracture will be conducted without any intraoperative imaging. Receives: Other: Conventional blind reduction technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 24 hours
Mouth opening
Interincisal opening measured between the incisal tips of central incisor teeth and recorded in millimeter using a vernier caliper.
Measured: at 24 hours postoperatively
Secondary outcomes (3)
Operative time
Additional time required to reduce with intervention.
Measured: Intraoperative
Number of attempts or reduction
Additional attempts required with imaging guidance.
Measured: Intraoperative
Cost of intervention
Additional cost required with imaging guidance.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study startJun 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomatic Arch FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Medical Sciences Teaching Hospital. Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashutosh Kumar Singh, College of Medical Sciences Teaching Hospital. Nepal
- Investigators
- Ashutosh K Singh, MDS, Principal investigator, College of Medical Sciences, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528264
- Sponsor's protocol ID
- CMSNepal
- Status last verified
- Oct 2020
- First submitted
- 22 Aug 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully sharable link will be provided after study completion with deidentified data
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Closed Reduction of Depressed Zygomatic Arch Fractures Compared to Conventional Blind Reduction: A Randomized Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04528264
- Acronym / sponsor ID
- CMSNepal
- Conditions
- Zygomatic Arch Fracture
- Keywords
- zygomatic arch fracture, Intraoperative Imaging, guided reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- College of Medical Sciences Teaching Hospital. NepalUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blind
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided | Experimental | Device: Intraoperative ultrasound guidedIntraoperative high frequency ultrasound used to guide the reduction of depressed zygomatic arch. |
| Conventional blind reduction technique | Other | Other: Conventional blind reduction techniqueConventional blind reduction of zygomatic arch fracture will be conducted without any intraoperative imaging. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 6 years and above
- fractured and depressed zygomatic arch requiring surgical reduction
Key exclusion criteria (3 listed)
- pregnant patients
- not willing for participation
- below 6 years age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative ultrasound guidedAlso: Intraoperative USG ImagingSamsung 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. | Device | Ultrasound guided |
| Conventional blind reduction techniqueAlso: comparatorConventional blind reduction technique | Other | Conventional blind reduction technique |
Primary outcome
Post operative radiographic evidence of adequate reduction
Time frame: 24 hours
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
Facial profile symmetry
Time frame: one week to four weeks
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
Time frame: 24 hours
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
Time frame: at 24 hours postoperatively
Interincisal opening measured between the incisal tips of central incisor teeth and recorded in millimeter using a vernier caliper.
3 secondary outcomes
Operative time
Time frame: Intraoperative
Number of attempts or reduction
Time frame: Intraoperative
Cost of intervention
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Yes. Fully sharable link will be provided after study completion with deidentified data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashutosh K Singh, MDS principal investigator
College of Medical Sciences, Nepal
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative ultrasound guided and Conventional blind reduction technique in people with Zygomatic Arch Fracture, run by College of Medical Sciences Teaching Hospital. Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashutosh K Singh, MDS (+9779804244369, dr.ashutosh@cmsnepal.edu.np), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative radiographic evidence of adequate reduction (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.