- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04111562
Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects (Cranioplasty)
Background: The percentage of permanent infirmities following traumatic cranial bone cranial bone defects following trauma for restoration of function and cosmoses. This study designed to evaluate the influence of cranioplasty as a method of skull repair on work capability of the patients and their employability.
Methods: The authors compared the work capability and employment of 35 patients with traumatic cranial bone defects after head trauma treated in the Neurosurgery Department of Assiut University Hospitals, Egypt from January 2013 to January 2018 before and after cranioplasty.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Assiut, Egypt, 71111
- Recruiting
- Emanaalah shaltouy@yahoo.com
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Contact:
- Eman S Shaltout, MD
- Phone Number: 00201094149135
- Email: emansalahshaltout@yahoo.com
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Contact:
- Wael M Abd-ElGhani, MD
- Phone Number: 00201098196217
- Email: waelneuro@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Patients with traumatic skull bone defects
Exclusion Criteria:
• Patients were not working before trauma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: polymethyl methacrylate Cranioplasty
The Cranioplastic kit used (Teknimed, Biomaterials Innovation, Gentafix 1 ®, France) a biocompatible material that is composed of powder and liquid form of polymethyl methacrylate.
|
Bone grafts
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with complications
Time Frame: 6 months up to one year
|
the number of patients with complications after cranioplasty as a method of skull repair.
|
6 months up to one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Cranioplasty2018
- Assiut University (Other Identifier: Assiut University Hospitals)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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