A Randomized, Double-blind Controlled Trial Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement for the Management of Chronic Lateral Epicondylitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in Mayo Elbow Performance Score
研究概览
简要总结
We propose a randomized, double-blind controlled trial comparing arthroscopic release with arthroscopic debridement for the management of chronic tennis elbow in an effort to definitively determine whether arthroscopic tennis elbow release is an effective treatment of tennis elbow, and to further provide better recommendations for the use of this procedure, in an effort to improve patient care.
详细描述
Lateral epicondylitis (tennis elbow) is a common occurrence in the general population with an incidence of 4-7/1000/year. More recent literature describes a 1-3% rate over the course of a lifetime, most typically affecting individuals between the ages of 35 and 50.
Tennis elbow is a common occurrence in the general population that causes lateral elbow pain and diminished grip strength, which may be debilitating. Most affected individuals achieve symptom resolution within 6 months to 1 year with measures such as physiotherapy, anti-inflammatories and corticosteroid injections, but a small subset will go on to develop chronic symptoms. Chronic tennis elbow can be treated surgically, by arthroscopic tennis elbow release (ATER), which has gained popularity in recent years as it presents a less invasive option, allows for direct visualization of the elbow joint for other pathology and has a faster return-to-work time compared to other surgical procedures. Despite its promise there have been no high quality studies evaluating the efficacy of arthroscopic tennis elbow release, bringing the actual efficacy of this procedure into question. A randomized controlled trial on arthroscopic tennis elbow release would provide much needed evidence in order to define its role in the management of tennis elbow and to help refine treatment protocols.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms consistent with lateral epicondylitis persisting for >6 months, and have failed conservative management
- •Adult, skeletally mature (>18yrs)
- •Provision of informed consent
排除标准
- •Alternative diagnosis that better explain their symptoms
- •Previous elbow trauma or surgery
- •Case involving workplace insurance claims (e.g. WSIB)
- •Unwilling, or unlikely in the opinion of the investigator to be followed for the duration of the study (e.g., patient refusal, unfixed address, plans to move...etc.)
- •Cognitive difficulties that prevent ability to provide informed consent and reliable completion of questionnaires
- •Bilateral lateral epicondylitis
结局指标
主要结局
Change in Mayo Elbow Performance Score
时间窗: From baseline to up until 24-Months Post-Operative
The Mayo Elbow Performance score is an outcome measure specific to the elbow to assess activities of daily living (ADLs). This outcome measure consists of 4 subscales: pain, range of motion, stability and daily function. Each section is combined for a total score out of 100 points. A higher score, indicates a better outcome.
次要结局
- Change in Disabilities of the Arm, Shoulder and Hand (DASH)(From baseline to up until 24-Months Post-Operative)
- Change in Oxford Elbow Score (OES)(From time of enrollment up until 2-years post-operative)
- Adverse Events(Ongoing from time of enrollment, up until 24-months post-operative)
- Change in American Shoulder and Elbow Surgeons Elbow (ASES)(From baseline to up until 24-Months Post-Operative)
- Change in Grip Strength(From time of enrollment up until 2-years post-operative)