A Comparative Study Between Cranioplasty Using Titanium Mesh Vs Bone Cement
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Patient satisfaction using patient ssatisfaction grade
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with active infection at the surgical site
- •Patient Unfit for surgery.
- •Patient refuse consent
结局指标
主要结局
Patient satisfaction using patient ssatisfaction grade
时间窗: 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
次要结局
- 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)
研究者
Osman Hassan Osman Zafraan
Resident doctor
Assiut University