Prospective Randomized Controlled Study on Arthroscopic Treatment Combine With TXA for Elbow Stiffness
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mayo Elbow Performance Score
研究概览
简要总结
This study is a prospective randomized controlled study of different arthroscopic treatments for elbow stiffness combined with tranexamic acid(TXA) injection. The patients with stiffness were randomly divided into groups before the operation. After the arthroscopic operation was completed, they were divided into a local TXA injection group and a control group (normal saline) to perform additional operations for reduction of hemorrhage. In different time periods, the quantitative and qualitative indicators including pain, functional score, range of motion, level of Hemoglobin, the circumference of the limb 10cm above and below the elbow, amount of hemorrhage, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with TXA on the treatment of reduction of hemorrhage. Determine the effectiveness of TXA.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed patients with elbow stiffness Young and middle-aged patients aged 18 to 60 with failed nonoperated treatment Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients No other comorbidities or medical diseases affect the surgical patients -
排除标准
- •Elderly people older than 60 years old and patients younger than 18 years old With severe comorbidities or medical diseases affect the surgical patients
研究组 & 干预措施
Study group
Arthroscopic treatment with TXA injection
干预措施: TXA (Drug)
Control group
Arthroscopic treatment with normal saline injection
干预措施: Saline (Drug)
结局指标
主要结局
Mayo Elbow Performance Score
时间窗: baseline-6 months postoperatively
A score used to evaluated the elbow function
次要结局
- Visual analogue scale(baseline-6 months postoperatively)
- Circumference of upper extremity(baseline-6 months postoperatively)
- change of hemoglobin(baseline-6 months postoperatively)
- range of motion(baseline-6 months postoperatively)
研究者
Yi Lu
Director of Sports Medicine Service of Beijing Jishuitan hospital
Beijing Jishuitan Hospital