The Functional Outcome of the Arterial Tourniquet in Total Knee Arthroplasty- a RCT of Bilateral Total Knee Arthroplasties.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Postoperative pain
研究概览
简要总结
This study describes in a randomised controlled trial how the tourniquet influence the outcome af a total knee replacements
详细描述
Background: Tourniquet application during total knee arthroplasty (TKA) is a common practice aimed at reducing intraoperative bleeding. However, concerns have been raised about potential tissue damage from ischemia and reperfusion injury.
Objectives: This study examines the effects of tourniquet use during TKA on postoperative functional outcomes, including pain, range of motion (ROM), and patient-reported outcomes (PROMs).
Methods: In a fast-track surgical setting, a prospective, randomized, double-blinded trial was conducted with patients undergoing bilateral TKA. Tourniquets were applied to one knee, while the contralateral knee served as a control. Evaluations were conducted at two and four weeks, and at three and twelve months postoperatively, employing paired t-tests and mixed-effects linear modeling for data analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The protocol for tourniquet application during TKA began with encasing the patient's thigh in a stockinette sleeve, followed by the fitting of the tourniquet cuff which was connected to the Zimmer A.T.S 3000 tourniquet system. To ascertain the individualized optimal pressure, a pulse oximeter was momentarily placed on the patient's limb before the cuff was inflated. The tourniquet was used from the start of the incision and was released just prior to closure of the joint capsule to ensure optimal hemostasis during the final stages of the procedure.
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
- •Aged 18 years or older, planned for bilateral cemented primary TKA due to osteoarthritis during the same session. and showed a uniform degree of osteoarthritis determined by the Kellgren-Lawrence classification
排除标准
- •non-Danish speaking patients, unable to cooperate for VAS scoring, coagulation disorders, salicylate-induced asthma, severe thrombocytopenia, serious heart failure, severe liver failure, hypovolemia (any cause), dehydration, angioedema, bronchospasm, undergoing lithium treatment, suspected or manifest gastrointestinal bleeding, cerebrovascular bleeding, high postoperative bleeding risk or delayed hemostasis, hypersensitivity to adrenaline, sympathomimetics or excipients , hypertrophic or ischemic heart disease, undergoing dihydroergotamine treatment and thyrotoxicosis
结局指标
主要结局
Postoperative pain
时间窗: 2 weeks postoperatively
Pain at rest evaluated at a visual analogue scale (VAS)
次要结局
- Wound complications and deep vein thrombosis and re-admissions(within one year postop)
- Forgotten Joint Score (FJS) and Oxford Knee Score (OKS)(two weeks, four weeks, three months and one year postop)