Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Knee society score
研究概览
简要总结
This study is randomized controlled trial with 5 years follow up and involved 101 patients divided in two groups; group A in which tourniquet was used in total knee arthroplasty while group B in which tourniquet was not used. All these patients were analyzed for the clinical and functional outcome measures.
详细描述
In this study, investigators have primary outcome measures and secondary outcome measures which were assessed in multiple periods to see the effects of using tourniquet in total knee arthroplasty on the clinical and functional outcomes with follow up of 5 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blinded study
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Grade 3 and 4 osteoarthritis
- •age 55-80 years
- •patients agree to participate in the study
排除标准
- •Diabetes mellitus .Symptomatic spinal pathology with moderate to severe cervical or lumbosacral spinal stenosis.
- •Hip pathology like osteoarthritis or fractures
- •Neuromuscular disorders
- •Blood dyscrasia or anticoagulant treatment .Body mass index equal to 30 or more.
- •Previous knee surgery or knee infection
- •Peripheral vascular disease
- •Rheumatoid arthritis
- •Hemoglobin less than 12 gram/deciliter
结局指标
主要结局
Knee society score
时间窗: This score was assessed at 5 years postoperatively
Knee society score for functional outcome which will be low in poor function and high in best function
Knee injury and osteoarthritis outcome scores
时间窗: This score was assessed at 5 years post-operatively
Knee injury and osteoarthritis outcome score which will be low in poor function and high in better function
VAS for thigh pain
时间窗: This score was assessed at 1st day post-operatively
Visual analogue scale for thigh pain which will be high in more pain and low in less pain
次要结局
- Post operative complications(These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.)
研究者
Sherwan Ahmed Ali Hamawandi
Assistant professor of orthopedic surgery
Hawler Medical University