Outcomes Following Tourniquet and Non-Tourniquet Assisted Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Change from baseline in Quadriceps Muscle Force
研究概览
简要总结
The overall goal of this study is to determine the effects of intraoperative tourniquet use during total knee arthroplasty (TKA), compared to TKA without the use of a tourniquet (NOTQT), for strength and functional recovery following simultaneous bilateral TKA. During the procedure, each patient will receive tourniquet-assisted TKA (TQT) on one lower extremity while the contralateral lower extremity undergoes TKA without the use of a tourniquet (NOTQT), except for briefly during component cementation. Tourniquets are commonly used in TKA to improve visualization of the surgical field and limit blood loss. However, studies suggest that tourniquet use may be associated with higher rates of medical complications and poor functional outcomes, including increased swelling, decreased muscle strength and altered neuromuscular activity. We will measure strength, voluntary muscle activation, and other functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs after surgery); 3 weeks; and 3 months following TKA). We hypothesize that lower extremities in the NOTQT group will demonstrate improved strength and performance when compared to lower extremities in the TQT group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing primary, simultaneous bilateral knee arthroplasty for osteoarthritis
排除标准
- •no neurological, vascular or cardiac problems that limit function or any unstable orthopaedic conditions that limit functional performance
结局指标
主要结局
Change from baseline in Quadriceps Muscle Force
时间窗: Pre-operative, 3 weeks and 3 months post-operative
NOTQT will result in greater quadriceps muscle strength (primary outcome) after TKA, compared to TQT group. Benefits will be apparent at 48-72 hrs and 3 weeks (primary endpoint), and persist though 3 months following TKA
次要结局
- Change from Baseline in Isometric Hamstring Strength(Pre-operatively, 3 weeks and 3 months post-operative)
- Change from Baseline from Voluntary Quadriceps Activation(Pre-operative, 3 weeks and 3 months post-operative)
- Change from Baseline in Balance testing(Pre-operatively, 3 weeks and 3 months post-operative)
- Change from Baseline in Range of Motion(Pre-operatively, 3 weeks and 3 months post-operatively)