Efficacy of Cetylated Fatty Acid for Alleviating Postoperative Pain After Total Knee Arthroplasty: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Knee skin temperature
研究概览
简要总结
To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-80 years
- •Osteoarthritic knee patients underwent unilateral primary TKA
- •Participants understand and consent to the protocol of the trial
排除标准
- •Inflammatory knee arthritis
- •Previous knee surgery or trauma
- •Previous knee infection
- •Skin problem around the knee such as eczema, psoriasis, wound infection
- •Allergy to studied drug
研究组 & 干预措施
cetylated fatty acid
Topical cetylated fatty acid, apply 2 times/day for 6 weeks after operation
干预措施: cetylated fatty acid (Drug)
Placebo
Topical placebo, apply 2 times/day for 6 weeks after operation
干预措施: Placebo (Drug)
结局指标
主要结局
Knee skin temperature
时间窗: post-op week12
evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee
Visual analog scale
时间窗: post-op week12
VAS (0-100) at rest and on motion
inflammatory marker
时间窗: post-op week12
ESR and CRP
次要结局
- Knee Range of Motion(post-op week12)
- Thai forgotten joint score(post-op week12)
- Knee circumference (cm)(post-op week12)
- Modified WOMAC(post-op week12)
研究者
Supakit Kanitnate
Principle investigator
Thammasat University