Comparative Study of Suture-Tied versus Titanium Plate Fixation in Cranioplasty Procedures
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Titanium plate fixation may provide better structural integrity, but suture fixation may show similar clinical outcomes with reduced cost and resource use
研究概览
简要总结
Introduction
Cranioplasty is a surgical procedure aimed at repairing cranial defects resulting from trauma, decompressive craniectomy, tumor excision, or congenital anomalies. The choice of fixation technique plays an important role in postoperative outcomes. Titanium plates have been the gold standard due to their rigidity and biocompatibility. However, suture-tied fixation is a cost-effective and simpler method often preferred in resource-limited settings. This study aims to compare both methods in surgical outcomes, complication rates, and cost-effectiveness.
Need and Significance of the Study
There is limited comparative literature available evaluating suture-tied fixation with titanium plates in cranioplasty. With rising healthcare costs, assessing simpler and affordable alternatives without compromising outcomes is critical. This study may offer insights that can help guide surgical practices, especially in low-resource settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients, post decompressive craniectomy defects.
排除标准
- •Active infection, immunocompromised state, pediatric patients.
结局指标
主要结局
Titanium plate fixation may provide better structural integrity, but suture fixation may show similar clinical outcomes with reduced cost and resource use
时间窗: 6 months
次要结局
- Both methods may show comparable complication rates(6 months)
研究者
Jitin Bajaj
Netaji Subhash Chandra Bose Medical College