Comparison to Short-duration Tourniquet Total Knee Arthroplasty (TKA) With the Aquamantys® Bipolar Sealer and the Standard of Care in the Setting of Outpatient TKA: A Randomized, Double-blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Isometric Quadriceps Strength
研究概览
简要总结
The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption and patient function during the first three months after short-stay total knee replacement between patients treated with short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).
By doing this study, investigators hope to learn if short duration tourniquet knee replacement with the Aquamantys® bipolar sealer is more effective than standard of care (tourniquet used throughout the case and no Aquamantys®). The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption and patient function during the first three months after short-stay total knee replacement between patients treated with short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •primary total knee arthroplasty
排除标准
- •repeat knee replacement (revision arthroplasty)
- •bilateral knee replacements on the same day
- •partial knee replacements
- •health or social limitations that do not allow for the participant to be discharged to home on the same day or day after surgery.
研究组 & 干预措施
Aquamantys
The Aquamantys bipolar sealer is a device used during surgery to help reduce bleeding in the joint. The system uses radiofrequency energy and sterile saline (salt water) to close small blood vessels in the knee to help reduce bleeding.
干预措施: Aquamantys (Device)
Standard of Care: Tourniquet
Standard of care for reducing bleeding during the total knee arthroplasty
干预措施: Tourniquet (Device)
结局指标
主要结局
Isometric Quadriceps Strength
时间窗: 2 weeks
The participant will sit in a seated position and a stabilizing strap will be placed around the bottom of the participant's shank and attached to a hand-held dynamometer. The participant will be asked to slowly kick the foot as hard as they can into the dynamometer pad (muscle testing hardware), and force will be measured. Increased measured force indicates greater quadriceps strength. Measurements will be recorded for both the operative extremity and the non-operative extremity, and the results will be expressed as a percentage of the mean strength measured in operative extremities compared to that measured in non-operative extremities for each study group.
次要结局
- Emotional Health (VR-12 MCS)(Preoperative)
- Knee Function Questionnaire(Preoperative, 2 weeks, 6 weeks, 12 weeks)
- Pain (VAS)(Preoperative, 2 weeks, 6 weeks, 12 weeks)
- Opioid Use(Preoperative, 2 weeks, 6 weeks, 12 weeks)
- Knee Osteoarthritis (KOOS,JR)(2 weeks post-op, 6 weeks post-op)
- Isometric Quadriceps Strength(6 weeks and 12 weeks)
- Sit to Stand Test(6 weeks, 12 weeks)
研究者
Stephen Duncan
Associate Professor
University of Kentucky