NCT04111562

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

February 25, 2019

Last Update Submit

September 30, 2019

Conditions

CranioplastyDisability PhysicalTrauma

Keywords

Cranial defectskull bone defects

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

polymethyl methacrylate Cranioplasty

OTHER

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

Interventions

CranioplastyPROCEDURE

Bone grafts

polymethyl methacrylate Cranioplasty

Eligibility Criteria

Age14 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with traumatic skull bone defects

You may not qualify if:

  • Patients were not working before trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emanaalah shaltouy@yahoo.com

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in forensic medicine and clinical toxicology

Study Record Dates

First Submitted

February 25, 2019

First Posted

October 1, 2019

Study Start

March 3, 2017

Primary Completion

March 3, 2020

Study Completion

March 3, 2020

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations

EG(1)