Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 refractory external humeral epicondylitis combined with platelet rich plasma (PRP) injection. The patients with intractable external humeral epicondylitis were randomly divided into groups before the operation. After the arthroscopic operation was completed, they were divided into a local PRP injection group and a control group (normal saline) to perform additional operations on the damaged tendons, each for up to half a year after the operation. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with PRP on the treatment of damaged tendons. Determine the effectiveness of PRP. At the same time, in the process of arthroscopic treatment, look for risk factors that affect the curative effect of intractable external humeral epicondylitis, as well as the causes and prevention of common complications.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed patients with refractory external humeral epicondylitis (preoperative MRI confirmed loss of ECRB integrity) patients who have received non-surgical treatment with poor efficacy
- •Young and middle-aged patients aged 20 to 60, who have not previously received local injection therapy
- •Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients
- •No other comorbidities or medical diseases affect the surgical patients
- •Unilateral disease
排除标准
- •Early patients who have not received standard non-surgical treatment
- •Patients who have received hormone injections or "small needle knife therapy" and other invasive procedures within three months before surgery, poor skin conditions, and local infections
- •Elderly people older than 60 years old and patients younger than 20 years old
- •Unable to accept randomization, insufficient follow-up time or lost to follow-up
- •Bilateral disease
- •Combined immune disease
研究组 & 干预措施
Study group
Arthroscopic treatment with PRP injection
干预措施: PRP (Drug)
Control group
Arthroscopic treatment with normal saline injection
干预措施: normal saline (Drug)
结局指标
主要结局
Mayo Elbow Performance Score
时间窗: 3, 6 weeks and 3, 6, 12, 24 months postoperatively
A score used to evaluated the elbow function, higher scores mean a better outcome.
次要结局
- visual analog scale (VAS)(3, 6 weeks and 3, 6, 12, 24months postoperatively)
- scoring system of Verhaar(3, 6 weeks and 3, 6, 12, 24months postoperatively)
- Disability of the Arm, Shoulder, and Hand (DASH)(3, 6 weeks and 3, 6, 12, 24months postoperatively)
- Patient-Rated Tennis Elbow Evaluation (PRTEE) scale(3, 6 weeks and 3, 6, 12, 24months postoperatively)
- Integrity of the tendon in MRI(3, 6, 12, 24 months postoperatively)
研究者
Yi Lu
Director of Sports Medicine Service of Beijing Jishuitan hospital
Beijing Jishuitan Hospital