The Surgical and Economic Effect of the Aquamantys System in Blood Management During and Following Aseptic and Septic Revision TKA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Blood Loss and Post-Operative Transfusion Rate
研究概览
简要总结
To assess the surgical and economic effectiveness of the Aquamantys System in managing intra- and post-operative blood loss, and reducing transfusion needs in patients undergoing both aseptic and septic revision total knee arthroplasty.
详细描述
The use of the saline-coupled bipolar sealing technology (Aquamantys® System, Medtronic Advanced Energy, LLC, Portsmouth, NH, USA) represents a modern approach to reducing perioperative blood loss in patients undergoing total joint arthroplasty. Unlike standard electrocautery, which use monopolar radiofrequency energy, this technology uses bipolar radiofrequency energy combined with a continuous-flow saline at the electrode tip to prevent tissue temperatures from exceeding 100 °C thus minimizing tissue charring. This eliminates the smoke and eschar formation seen with standard electrocautery. The temperature achieved is sufficient to induce a process called Transcollation(TM) which shrinks the collagen fibers in the walls of blood vessels, effectively sealing the blood vessels up to 1mm in diameter, resulting in the reduction of bleeding from soft tissue.
Suction is used to remove the saline from the surgical field with the treated tissue turning a light tan color. With normal use, the depth of penetration of this effect is typically less than 2mm. The technology is cleared by the US FDA (510(k)) and EU (CE Mark) for use on soft tissue & bone and will be used according to its intended packaging indications for use. The current assessment proposes a technique in which a disposable Aquamantys® hand piece is used to treat targeted areas which are bleeding or expected to bleed during surgery.
This postmarket study will assess the surgical and economic effectiveness of Aquamantys® System in managing intra-operative blood loss and transfusion rates in patients undergoing septic and aseptic revision TKA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •The patient is greater than 18 years of age
- •Patients following failure of primary, unilateral TKA
- •The degree of revision requires the use of an extended osteotomy for component removal
- •Patient has participated in the informed consent process and has signed an Ethics Committee approved informed consent
排除标准
- •Patients presenting with a history of bleeding disorders and/or are on chronic blood anticoagulation therapy
- •Patients presenting with an internal cardiac defibrillator
- •Women who are pregnant
- •Prisoner or transient
- •Recent history of known narcotic abuse
- •Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires
- •Subject unwilling to undergo blood transfusion, if necessary
研究组 & 干预措施
ASEPTIC Revision TKA & Aquamantys System
Single-stage revision TKA cases performed for aseptic failure requiring an extended osteotomy for component removal and intra-operative blood management (bipolar sealing) with the Aquamantys® System. These will be compared to in-house matched historic control using patients presenting with ASEPTIC failed primary TKA and revised without use of the Aquamantys® System.
干预措施: Aquamantys System (Procedure)
SEPTIC Revision TKA & Aquamantys System
Single-stage revision TKA cases performed for septic failure requiring an extended osteotomy for component removal and intra-operative blood management (bipolar sealing) with the Aquamantys® System. These will be compared to in-house matched historic control using patients presenting with SEPTIC failed primary TKA revised without use of the Aquamantys® System.
干预措施: Aquamantys System (Procedure)
结局指标
主要结局
Blood Loss and Post-Operative Transfusion Rate
时间窗: 14 days
To reduce blood loss and post-operative transfusion rates in patients undergoing total joint arthroplasty. This will be achieved using the Aquamantys system. The Aquamantys system provides transcollation which shrinks the collagen fibers in the walls of blood vessels, effectively sealing the blood vessels up to 1mm in diameter, resulting in the reduction of bleeding from soft tissue.
次要结局
- Operative room and total hospital costs(14 days)