The Effect of Tourniquet Use During Total Knee Arthroplasty Surgery on the Postoperative Loss of Quadricepsforce
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- isometric quadriceps-force measured
研究概览
简要总结
The purpose for this study is to investigate the quadriceps (thigh) function preoperatively and 48 hours postoperatively during knee arthroplasty (total replacement of the knee joint) in a randomised study with or without the use of a Tourniquet (cuff around the thigh during surgery) (100 mm Hg > systolic blood pressure).
详细描述
Introduction It is established that knee arthroplasty generate a loss of 60-80 % quadriceps-force during the first 2-3 days postoperatively [1-4]. This can reduce the postoperative rehabilitation and walking function. There is, due to this fact, an increased interest in analysing the mechanism behind this quadriceps weakness [5].
One of the mechanism behind this could be the routinely used - but not evidence based - application of an intra operative tourniquet. Several studies, including reviews and meta-analysis show that the use of blood less field is debatable and can be one reason for localised muscle necrosis and increased pain. The use of a tourniquet and the effect on the total perioperative blood loss is doubtful [6-11].
The use of a tourniquet or not has no effect on the prosthetic fixation to the bone (Molt/STL) The influence on the late (>2 weeks) quadriceps function and rehabilitation is even debatable.
[6-11], but there is no investigation on the effect of the use of a tourniquet on the early significant loss of quadriceps-function.
The purpose for this study is to investigate the quadriceps function preoperatively and 48 hours postoperatively during knee arthroplasty in a randomised study with or without the use of a Tourniquet (100 mm Hg > systolic blood pressure).
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
- 41 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients > 40 < 80 years planed for a total knee arthroplasty The patient will be given a written informed consent to participate in this clinical investigation.
- •The patient understand the clinical investigation and will cooperate with the investigational team
排除标准
- •Preoperatively <90 flexion, > 10 extensionsdeficit. Rheumatoid arthritis, other forms of inflammatory disease or autoimmune disorders Immunosuppresed patient Systemic corticosteroid used in previous 6 month Previous major knee surgery as osteotomy, knee related fractures, BMI<35 Diabethic neuropathy Preopratively opiod or garbabentine treatment Psychiatric disorders Planed for simultaneous bilateral knee arthroplasty
研究组 & 干预措施
Tourniquet
The Torniquet will be inflated to 100 mmHg over systolic pressure just before skin incision. The tourniquet will be deflated when the last stich/agraf is fixed
干预措施: Tourniquet (Device)
No tourniquet
The patients operated on in the non-tourniquet group will have the same surgery and surgical technique but without tourniquet
hyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks.
结局指标
主要结局
isometric quadriceps-force measured
时间窗: pre operatively and 48 hrs post op
isometric quadriceps-force measured in an isokinetic dynameter (Biodex III). The patient is sitting in the dynameter-chair with 60° knee-flexion. After a pretest training, instruction and two suboptimal trials, the patient will do 5 maximal isometric knee-extensions. The highest value measured will be expressed as the quadriceps-force in Nm/Kg bodyweight \[1\]. The knee circumference will be measured 1 cm proximal to the base of the patella with the patient relaxed in the supine position and the knee extended \[13\] The Quadriceps circumference will be measured 10 cm proximal to the base of the patella with the patient in supine position and the knee extended.
次要结局
- Pain(pre opertively and 48 hrs post op)