Bone Defects, Cranioplasty, Decompressive Craniectomy and Cranioplasty
Conditions
Keywords
Cranioplasty, Titanium mesh, Bone cement, Traumatic brain injury
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
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.
Interventions
PROCEDURECranioplasty with Titanium mesh
Cranioplasty using titanium mesh
PROCEDURECranioplasty with bone cement
Cranioplasty using bone cement
Sponsors
Osman Hassan Osman Zafraan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Titanium mesh VS Bone cement in Cranioplasty
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: * Patients requiring cranioplasty for a skull defect due to Decompressive Craniectomy, trauma, tumor resection, or congenital issues. * All ages . * Both sex. * Informed consent obtained from all participants. * Patient fit for surgery. *
Exclusion criteria
* Patients with active infection at the surgical site * Patient Unfit for surgery. * Patient refuse consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction using patient ssatisfaction grade | through study completion, an average 1 years | Patients satisfaction (cosmetic, psychological, neurologic ) measered by validate questionnaire post-opeartive and follow up using Patient satisfaction grade from Excellent to not satisfied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection | through study completion, an average 1 years | follow up rate of post operative infection |
| Reoperation | through study completion, an average 1 years | rate of reoperation after using each material a post-operative follow up |
| CSF leak | through study completion, an average 1 years | post-operative complication of CSF leak due to changes in Dynamics of CSF flow |
| complications | through study completion, an average 1 years | post-operative as hematoma formation , neurologic defict and fits. |
Countries
Egypt
Contacts
Primary ContactOsman Hassan Zafraan, Resident doctor
Outcome results
None listed