Comparison of Leukocyte-rich Platelet Rich Plasma Injection to Percutaneous Tenotomy in the Treatment of Chronic Common Extensor Tendinopathy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in function
研究概览
简要总结
This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy.
详细描述
This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy. Patients with a history of common extensor tendinopathy for greater than 3 months, refractory to conservative treatments, are randomized into one of two groups: injection with leukocyte rich platelet rich plasma or percutaneous tenotomy with the Tenex system. Both groups of patients are followed up in clinic at 1 week, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following the procedure to examine levels of pain or complications following both procedures.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 3 months of lateral elbow pain
- •Subjectively failed trial of physical therapy and counterbracing
- •Identifiable pathology on ultrasound (one or more of the following: thickened or disorganized tendon origin, microtearing, edema, neovascularization
排除标准
- •Steroid injection within the last 3 months
- •Previous surgery for common extensor tendinopathy
- •Current treatment with analgesics
- •Pregnant, non-English speaking, or illiterate individuals
- •History of anemia
- •History of bleeding disorder
- •Anticoagulant use
- •History of cervical radiculopathy
- •Hemoglobin less than 11 grams per deciliter
- •Hematocrit less than 33%
- •Platelet count outside of normal range of 150-400 x 1000 microliter
研究组 & 干预措施
Leukocyte rich platelet rich plasma injection
Patients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon
干预措施: Leukocyte rich platelet rich plasma (Biological)
Percutaneous tenotomy
Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device
干预措施: Percutaneous Tenotomy (Device)
结局指标
主要结局
Change in function
时间窗: up to 12 months post-procedure
Change in function will be measured using the Oxford Elbow score using a 48 point scale where a score of 0 indicates severe functional impairment and a score of 48 indicates no functional impairment
Change in pain: visual analogue scale
时间窗: up to 12 months post-procedure
Change in pain will be measured using a 10 point visual analogue scale where 0 represents no pain and 10 indicates the worst pain possible.
次要结局
未报告次要终点