Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
Study NCT ID:
NCT06662903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cranioplasty Using Titanium Mesh Vs Bone Cement
Sponsor:
Osman Hassan Osman Zafraan
Organization:
Study Overview
Official Title:
A Comparative Study Between Cranioplasty Using Titanium Mesh Vs Bone Cement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is:
To compare the surgical outcomes between titanium mesh and bone cement in cranioplasty.
To assess the complication rates associated with each material. To evaluate patient satisfaction and aesthetic results post-surgery
To compare the surgical outcomes between titanium mesh and bone cement in cranioplasty.
To assess the complication rates associated with each material. To evaluate patient satisfaction and aesthetic results post-surgery
Detailed Description:
Cranioplasty is a common neurosurgical procedure performed to repair skull vault defects.
The skull vault defects may result mostly after traumatic injuries as depressed skull fractures, Tumor removal (infiltrating skull bones), decompressive craniectomies, congenital anomalies or inflammatory lesions.
At present, there is no gold standard material for cranioplasty with the use of autologous bone as well as other synthetic materials as bone cement and titanium mesh.
Bone cement is malleable, lightweight, strong, and heat resistant, but it may cause burn injury during the process of its preparation and is used for relatively small defects.
Titanium mesh good mechanical strength, a low infection rate, and an acceptable cost but may cause metal allergy, tissue erosion, implant exposure, and deformity upon application of external force.
Cranioplasty not only provides Brain protection and cosmetic aspects but also, decrease incidence of epilepsy, relief to psychological drawbacks and increases social performance, restoring the dynamics of CSF.
The skull vault defects may result mostly after traumatic injuries as depressed skull fractures, Tumor removal (infiltrating skull bones), decompressive craniectomies, congenital anomalies or inflammatory lesions.
At present, there is no gold standard material for cranioplasty with the use of autologous bone as well as other synthetic materials as bone cement and titanium mesh.
Bone cement is malleable, lightweight, strong, and heat resistant, but it may cause burn injury during the process of its preparation and is used for relatively small defects.
Titanium mesh good mechanical strength, a low infection rate, and an acceptable cost but may cause metal allergy, tissue erosion, implant exposure, and deformity upon application of external force.
Cranioplasty not only provides Brain protection and cosmetic aspects but also, decrease incidence of epilepsy, relief to psychological drawbacks and increases social performance, restoring the dynamics of CSF.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: