A Comparative Study Between Cranioplasty Using Titanium Mesh Vs Bone Cement
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Bone Defects
- Sponsor
- Osman Hassan Osman Zafraan
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Patient satisfaction using patient ssatisfaction grade
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Osman Hassan Osman Zafraan
Resident doctor
Assiut University
Eligibility 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
Outcomes
Primary Outcomes
Patient satisfaction using patient ssatisfaction grade
Time Frame: 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 Outcomes
- Infection(through study completion, an average 1 years)
- Reoperation(through study completion, an average 1 years)
- CSF leak(through study completion, an average 1 years)
- complications(through study completion, an average 1 years)