Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique

Sponsor

Ahmed Morad (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04836130

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures reduction Using Patient Specific Guide (PSG) Versus Conventional Technique

Condition or Disease	Intervention/Treatment	Phase
Zygomatic Fractures	Procedure: patient specific guide Procedure: conventional technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique

Anticipated Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: (ZMC) Fractures reduction Using Patient Specific Guide (PSG)	Procedure: patient specific guide patient specific guide reduction
Active Comparator: (ZMC) Fractures reduction Using Conventional Technique	Procedure: conventional technique conventional anatomical reduction

Arm

Intervention/Treatment

Active Comparator: (ZMC) Fractures reduction Using Patient Specific Guide (PSG)

Procedure: patient specific guide

patient specific guide reduction

Active Comparator: (ZMC) Fractures reduction Using Conventional Technique

Procedure: conventional technique

conventional anatomical reduction

Outcome Measures

Primary Outcome Measures

accuracy of reduction of the fractured zygoma ( facial asymetry ) [up to 6 months]
assessed by ct

Secondary Outcome Measures

operation time [up to 6 months]
in hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ahmed Morad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Morad, lecturer assistant, Cairo University

ClinicalTrials.gov Identifier:

NCT04836130

Other Study ID Numbers:

Omfs 3.3.10

First Posted:

Apr 8, 2021

Last Update Posted:

Apr 8, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Zygomatic Fractures

Fractures, Bone

Study Results

No Results Posted as of Apr 8, 2021