Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Postoperative pain (visual analog scale) day 1-4
研究概览
简要总结
Total knee arthroplasty (TKA) is a successful treatment for end-stage osteoarthritis of the knee. The main advantages of TKA are to relieve the pain of the knee, improve the knee function, restore lower limb alignment, and improve the quality of life for patients. During TKA, some surgeons prefer using a scalpel while others using electrocautery to expose the articular cavity. Whether the use of scalpel can lead to better and faster recovery after the primary TKA is still controversial.
The aim of this study was to compare the clinical outcomes of using the scalpel and the electrocautery in primary TKA
详细描述
A randomized controlled trial of patients underwent primary TKA between October 2021 and October 2023. The groups will be determined by using the computer to generate a randomization lists. A total 132 patients were included with 66 patients in the scalpel group, 66 patients in the electrocautery group. All patients were evaluated using primary outcome : Post-operative Visual Analog Scale (VAS) of pain, secondary outcome: estimated blood loss and Knee Injury and Osteoarthritis Outcome Score (KOOS-JR)
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
- 58 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Osteoarthritis patient (KL classification gr 2-4)
- •Primary TKA
- •Varus deformity < 20 degree
- •Flexion contracture < 20 degree
排除标准
- •Coagulopathy
- •Platelet dysfunction
- •Inflammatory arthritis
- •Revision TKA
结局指标
主要结局
Postoperative pain (visual analog scale) day 1-4
时间窗: postoperative day 1-4
measure the Postoperative pain by using visual analog scale from 1 - 10, higher scores means worse outcome
次要结局
- Calculated blood loss(postoperative day 4)
- Functional score(follow up 2 weeks, 1,3,6 months)
研究者
Pawut Wattanapongsiri
Principal investigator
Police General Hospital, Thailand