NCT01003080已完成不适用
Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 4
- 主要终点
- Drain Output.
研究概览
简要总结
The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient indicated for total knee arthroplasty
排除标准
- •Patients undergoing revision total knee arthroplasty
- •Patients with blood disorders
- •Patients on chronic anti-thrombotic medication such as Coumadin
- •Patients with a history of deep vein thrombosis
- •Patients with a history of pulmonary embolism
研究组 & 干预措施
TKA with the Aquamantys for hemostasis
Experimental
This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
干预措施: Aquamantys Device (Device)
TKA without the Aquamantys for hemostasis
Active Comparator
This group will receive total knee arthroplasty using the standard treatment for hemostasis.
干预措施: Standard of care treatment for hemostasis during a total knee arthroplasty. (Other)
结局指标
主要结局
Drain Output.
时间窗: First 24 hours following surgery.
This is a measure of the average drain output collected in the first 24 hours following surgery.
次要结局
未报告次要终点
研究者
Sun Jin Kim
Chief of Adult Reconstruction
Montefiore Medical Center
研究点 (4)
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