Back to resultsEvaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
Primary Purpose
Zygomatic Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patient specific guide
conventional technique
Sponsored by
About this trial
This is an interventional treatment trial for Zygomatic Fractures
Eligibility Criteria
Inclusion Criteria:
• Zygomatic Fracture Type III, IV and V according to rowe and killey classification(13)
- Age (18-60 years)
- Recent fracture (less than 2 weeks)
Exclusion Criteria:
• Zygomatic Fracture Type I, II and VI according to rowe and killey classification(13)
- Medical compromised patient
- Patient on radiotherapy
- Bone disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
(ZMC) Fractures reduction Using Patient Specific Guide (PSG)
(ZMC) Fractures reduction Using Conventional Technique
Arm Description
Outcomes
Primary Outcome Measures
accuracy of reduction of the fractured zygoma ( facial asymetry )
assessed by ct
Secondary Outcome Measures
operation time
in hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04836130
Brief Title
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
Official Title
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Morad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zygomatic Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
(ZMC) Fractures reduction Using Patient Specific Guide (PSG)
Arm Type
Active Comparator
Arm Title
(ZMC) Fractures reduction Using Conventional Technique
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
patient specific guide
Intervention Description
patient specific guide reduction
Intervention Type
Procedure
Intervention Name(s)
conventional technique
Intervention Description
conventional anatomical reduction
Primary Outcome Measure Information:
Title
accuracy of reduction of the fractured zygoma ( facial asymetry )
Description
assessed by ct
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
operation time
Description
in hours
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Zygomatic Fracture Type III, IV and V according to rowe and killey classification(13)
Age (18-60 years)
Recent fracture (less than 2 weeks)
Exclusion Criteria:
• Zygomatic Fracture Type I, II and VI according to rowe and killey classification(13)
Medical compromised patient
Patient on radiotherapy
Bone disease
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
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