NCT06947655招募中不适用
Impact of Two Different Perioperative Tourniquets on Blood Loss, Surgical Field and Surgeon Satisfaction During Total Knee Arthroplasty
University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood Loss
研究概览
简要总结
The present study investigates the impact of two different perioperative tourniquets with different closing features on operative blood los, surgical field quality and surgeon satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inidication for a Total Knee Arthroplasty
- •Approval for Surgery by the Department of Anesthesia
排除标准
- •Open Wounds of the lower extremities
- •Acute or chronic infections of the lower extremities
研究组 & 干预措施
Control
Active Comparator
The active control group receives a standarized FDA approved perioperative tourniquet (VBM-Tourniquet, VBM Medical, Sulz, Germany).
干预措施: VBM Tourniquet (Device)
Intervention Group
Experimental
The intervention groups receives a standarized, FDA-approved perioperative tourniquet (Adaptive Cuff, Delfi Medical Innovations Inc., Vancouver, Canada).
干预措施: Adaptive Cuff (Device)
结局指标
主要结局
Blood Loss
时间窗: Perioperative
Perioperative blood loss in ml.
Surgeon Satisfaction
时间窗: Perioperative
Surgical Satisfaction on a 0-100 mm VAS
次要结局
未报告次要终点
研究者
Alexander Franz
Dr. med., B.Sc.
University Hospital, Bonn
研究点 (1)
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