Comparison of Steroid, Platelet-rich Plasma and Platelet-rich Plasma Plus Hyaluronic Acid Injection for Rotator Cuff Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Constant-Murley Shoulder Score (CMSS)
研究概览
简要总结
Rotator cuff tear is a common cause of shoulder pain. Steroids, hyaluronic acid (HA), and platelet-rich plasma (PRP) injections are becoming popular for the treatment of chronic rotator cuff partial tear. The investigators plan to evaluate the effect of the new product of PRP combined with HA on the rotator cuff and prove its benefit of pain control and function recovery.
详细描述
Rotator cuff tear is a common cause of shoulder pain. Steroids, hyaluronic acid (HA), and platelet-rich plasma (PRP) injections are becoming popular for the treatment of chronic rotator cuff partial tear. The investigators plan to evaluate the effect of the new product of PRP combined with HA on the rotator cuff and prove its benefit of pain control and function recovery.
- Name: Cellular matrix™ PRP-HA
- Dosage form: Cellular Matrix A-CP-HA Kit (Ref. A-CP-HA-3)
- Dose(s): 3 mL of platelet-rich plasma (PRP) combined with 2 mL of hyaluronic acid
- Dosing schedule: one injection. After collecting 6 mL of blood collection and then centrifugation for 5 minutes, the PRP with a platelet concentration 1.5-1.6 times higher than the baseline in blood, deprived of contamination with red and white blood cells, entrapped in a 3D network of HA
- Mechanism of action: PRP contains rich growth factors and HA could function as bio-scaffold. They have a synergic effect on tissue repair.
- Pharmacological category: class III medical device
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Shoulder pain for at least 1 months
- •B.partial-thickness tear diagnosed by MRI or Echo
- •C.age between 20 and 85 years old
排除标准
- •A. inflammatory disease, such as rheumatoid arthritis, SLE, etc.
- •B. pregnancy
- •C. known malignancy
- •D. hematologic disease (or hemoglobin <10 g/dl, platelet <150.000 ul)
- •E. history of shoulder infection
- •F. history of shoulder surgery
- •G. prior steroid injection for 3 times or more
- •H. full-thickness tear
- •I. other shoulder problems, such as osteoarthritis, fracture malunion, etc.
- •J. subjects who cannot comply with the protocol of study
- •K. The shoulder pain area has been treated with PRP for less than 3 months
结局指标
主要结局
Constant-Murley Shoulder Score (CMSS)
时间窗: before treatment, 4-week, 12-week, 24-week.
The Constant-Murley Shoulder Score (CMSS) is a multi-item functional scale assessing pain, ADL, ROM, and strength of the affected shoulder. score: 0-100. The higher score means the function feels good and painless.
次要结局
- American Shoulder and Elbow Surgeons (ASES) Score(before treatment, 4-week, 12-week, 24-week.)
- associated complications(before treatment, 4-week, 12-week, 24-week.)
- pain score (VAS)(before treatment, 4-week, 12-week, 24-week.)
- range of motion of shoulder(before treatment, 4-week, 12-week, 24-week.)
- the change of anatomy(before treatment, 4-week, 12-week, 24-week.)
研究者
Tien-Ching Lee
Department of Orthopaedics
Kaohsiung Medical University