Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
1 other identifier
interventional
26
0 countries
N/A
Brief Summary
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedApril 8, 2021
April 1, 2021
1 year
April 1, 2021
April 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
accuracy of reduction of the fractured zygoma ( facial asymetry )
assessed by ct
up to 6 months
Secondary Outcomes (1)
operation time
up to 6 months
Study Arms (2)
(ZMC) Fractures reduction Using Patient Specific Guide (PSG)
ACTIVE COMPARATOR(ZMC) Fractures reduction Using Conventional Technique
ACTIVE COMPARATORInterventions
patient specific guide reduction
conventional anatomical reduction
Eligibility Criteria
You may qualify if:
- Zygomatic Fracture Type III, IV and V according to rowe and killey classification(13)
- Age (18-60 years)
- Recent fracture (less than 2 weeks)
You may not qualify if:
- Zygomatic Fracture Type I, II and VI according to rowe and killey classification(13)
- Medical compromised patient
- Patient on radiotherapy
- Bone disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ahmed Moradlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- lecturer assistant
Study Record Dates
First Submitted
April 1, 2021
First Posted
April 8, 2021
Study Start
May 1, 2021
Primary Completion
May 1, 2022
Study Completion
June 1, 2022
Last Updated
April 8, 2021
Record last verified: 2021-04