Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Oxford Shoulder Score
研究概览
简要总结
The purpose of this study is to determine if autologous plasma (ACP) is beneficial for better and faster healing following an arthroscopic repair of the rotator cuff.
详细描述
The shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. If the tendon has to be fixed at the bone during surgery, the weak point in obtaining a successful surgery is the fixation of the tendon at the bone insertion site. Tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential. We can boost the healing process with a selective use of PRP (platelet rich plasma). In this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them.
In this study, we will test the Arthrex® Double Syringe System. With this system it is possible to obtain ACP (Autologous conditioned plasma) in one centrifugation step. The supernatant contains a concentration of thrombocytes which is twice as high as in the native blood. The concentration of the growth factors is 5-25x higher according to this.
We also want to test if one application of ACP is enough to get a short- and long-term benefit in healing following a rotator cuff tear.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotator cuff tears (supraspinatus and/or infraspinatus tendon) performed by Dr. Flury and Dr. Schwyzer
- •Suture bridge technique
- •No pregnancy at the date of the surgery for women of childbearing potential
- •Signed consent form
排除标准
- •Partial reconstruction of the rotator cuff (PASTA)
- •Open reconstruction
- •Tendon transfer (latissimus dorsi or pectoralis major)
- •Revision surgery
- •Omarthrosis (Level ≥ 2 Samilson & Prieto)
- •Systemic arthritis
- •Rheumatoid arthritis
- •Diabetes (insulin treated)
- •Requiring surgery in reconstruction of the subscapularis tendon
- •Progressive fat inclusion (fatty infiltration of the rotator cuff musculature Goutallier level IV
- •Acute or chronic infection
- •Pathological bone metabolism
- •Insufficient perfusion in the affected arm
- •Neuromuscular disease in the affected arm
- •Non compliance of the patient
- •Disorders which handicap or inhibit the patient to follow the orders of the clinical testers
结局指标
主要结局
Oxford Shoulder Score
时间窗: 3mo (6mo/24mo)
The Oxford Shoulder Score used after 3 months is the primary parameter. The Score tests the ability to participate in the patients' normal life before they got injured.
次要结局
- EQ-5D(3/6/24 mo)
- VAS Pain(10d po)
- MRI/X-Ray/Ultrasonic Diagnostics(6/24 mo)
- ASES Score(3/6/24mo)
- Constant Murley Score(3/6/24 mo)
- Measurement of the external rotation strenght(3/6/24 mo)
- QuickDASH(3/6/24mo)
- ROM(3/6/24mo)
- Measurement of the abduction strength(3/6/24 mo)
研究者
Matthias Flury
Principal Investigator
Schulthess Klinik