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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04111562
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Information provided by (Responsible Party):
Eman Salah Shaltout, Assiut University

Brief 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.

Condition or disease Intervention/treatment Phase
Cranioplasty Disability Physical Trauma Procedure: Cranioplasty Not Applicable

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects
Actual Study Start Date : March 3, 2017
Estimated Primary Completion Date : March 3, 2020
Estimated Study Completion Date : March 3, 2020

Arm Intervention/treatment
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.
Procedure: Cranioplasty
Bone grafts

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 66 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

• Patients with traumatic skull bone defects

Exclusion Criteria:

• Patients were not working before trauma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04111562

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Emanaalah Recruiting
Assiut, Egypt, 71111
Contact: Eman S Shaltout, MD    00201094149135   
Contact: Wael M Abd-ElGhani, MD    00201098196217   
Sponsors and Collaborators
Assiut University
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Responsible Party: Eman Salah Shaltout, Lecturer in forensic medicine and clinical toxicology, Assiut University Identifier: NCT04111562    
Other Study ID Numbers: Cranioplasty2018
Assiut University ( Other Identifier: Assiut University Hospitals )
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eman Salah Shaltout, Assiut University:
Cranial defect
skull bone defects