Treatment of Rotator Cuff Tears With Platelet Rich Plasma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.
详细描述
Patients who have rotator cuff pathology as established by clinical exam and confirmed with MRI and have failed activity modification, will be enrolled in this study. They will receive dual platelet rich plasma (PRP) injections, one into the rotator cuff insertion and one into the area of the tendon proximal to the insertion, in one treatment session. PRP will be prepared through a double spin technique to create two 4 cc doses for injection. Patients will evaluated at 6 months, 1 year and two years for improvement in symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Rotator cuff pathology established by exam
- •Rotator cuff pathology confirmed with MRI.
- •Failure to improve with activity modification and physical therapy
- •Willingness to stop all NSAID medication
排除标准
- •Additional significant shoulder pathology seen on xray or MRI including: severe arthritis, significant superior labrum anterior postierior (SLAP) Type II lesions and intra-articular loose bodies.
- •Shoulder surgery within 6 months.
- •Presence of full thickness rotator cuff tears in patients amenable to surgical repair.
结局指标
主要结局
Quick Disabilities of the Arm, Shoulder and Hand Score (Quick-DASH)
时间窗: change from baseline to 24 months
Quick-DASH questionnaire consists of 11 questions which are each scored 1-5. The scoring ranges from 0 for best to 100 for worst outcomes.
次要结局
- Visual Analog Scale (VAS) for pain(change from baseline to 24 months)
- Global Improvement(change from baseline to 24 months)