NCT03042546终止4 期
Calcium Sulfate Spacer in Open Tibia Fractures With Sub-segmental Bone Loss to Decrease the Need for Secondary Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Patients With a Nonunion
研究概览
简要总结
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.
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
- Single (Participant)
盲法说明
Patients are blinded
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open tibia shaft fracture treated with an IMN
排除标准
- 未提供
研究组 & 干预措施
Calcium Sulphate
Active Comparator
干预措施: Calcium Sulfate (Drug)
PMMA
Active Comparator
干预措施: PMMA (Drug)
Nothing
Active Comparator
干预措施: No treatment (Other)
结局指标
主要结局
Number of Patients With a Nonunion
时间窗: One Year
Radiographic healing at one year with no additional surgery
次要结局
未报告次要终点
研究者
Claude Sagi
Professor, Orthopedics
University of Washington
研究点 (1)
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