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NCT04111562 Clinical Trial

Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects

Trauma Clinical Trial

— Cranioplasty  

Official title:
Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04111562
Other study ID # Cranioplasty2018
Secondary ID Assiut Universit
Status Recruiting
Phase N/A
First received
Last updated
Start date March 3, 2017
Est. completion date March 3, 2020

Study information
Verified date September 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

Cranioplasty is surgical repair of a cranial bone defect, important to cover defects following skull trauma for restoration of function, cosmoses and protective effects. Cranioplasty is the surgical procedure in which the autologous skull, synthetic materials (titanium, methyl methacrylate, polyetheretherketone implants, hydroxyapatite, and bioceramics are used to repair the skull defect

Recruitment information / eligibility
Status Recruiting
Enrollment 35
Est. completion date March 3, 2020
Est. primary completion date March 3, 2020
Accepts healthy volunteers No
Gender All
Age group 14 Years to 66 Years
Eligibility Inclusion Criteria:

• Patients with traumatic skull bone defects

Exclusion Criteria:

• Patients were not working before trauma

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cranioplasty
Bone grafts

Locations
Country Name City State
Egypt Emanaalah shaltouy@yahoo.com Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with complications the number of patients with complications after cranioplasty as a method of skull repair. 6 months up to one year
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