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

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ClinicalTrials.gov Identifier: NCT04111562
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Eman Salah Shaltout, Assiut University

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE October 1, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE March 3, 2017
Estimated Primary Completion Date March 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects
Official Title  ICMJE Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects
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.

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cranioplasty
  • Disability Physical
  • Trauma
Intervention  ICMJE Procedure: Cranioplasty
Bone grafts
Study Arms  ICMJE 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.
Intervention: Procedure: Cranioplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2019)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 3, 2020
Estimated Primary Completion Date March 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

• Patients with traumatic skull bone defects

Exclusion Criteria:

• Patients were not working before trauma

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 66 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04111562
Other Study ID Numbers  ICMJE Cranioplasty2018
Assiut University ( Other Identifier: Assiut University Hospitals )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eman Salah Shaltout, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP