CTRI/2018/09/015680已完成Phase 3 4
: A study to evaluate the Clinical efficacy of indegineously produced, 3D printed patient specific acrylic cranial prosthesis in decompressive craniectomy
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cosmesis at the operative site,
研究概览
简要总结
the semi-crystalline PMMA implants were inserted in 10 patients. Cranial defect size ranged from 9.9-14.8cms. seven patients had traumatic brain injury and three had spontaneous ICH.casted PMMA flap had an average hardness of 160 MPa and tensile strength of ( 30.7+-3.9)MPa.one patient had infection requiring removal of acrylic flap. no hypersensitivity reaction noted in any patients. A cranial index of symmetry( CIS) of (94.5+- 3.9)% was achieved suggesting a good cosmetic outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •all patients who have undergone decompressive fronto temporoparietal craniectomy, coming for cranioplasty will be included.
排除标准
- •infection at the operative site pregnant women associated spinal cord injury.
结局指标
主要结局
Cosmesis at the operative site,
时间窗: 3 months
any other complications
时间窗: 3 months
Rate of infection at the operative site and
时间窗: 3 months
次要结局
- Cosmesis(6 months)
研究者
研究点 (1)
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