Effect of ACP on Surgical Repair of Rotator Cuff Tears
- Conditions
- Rotator Cuff Tears
- Interventions
- Device: Control groupDevice: Autologous conditioned plasma
- Registration Number
- NCT01266226
- Lead Sponsor
- Schulthess Klinik
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control group The patients are going to get an injection of 4mL saline solution under the footprint following an arthroscopic repair of the rotator cuff. ACP treated Autologous conditioned plasma The patients are going to get an injection of 4mL autologous conditioned plasma under the footprint following an arthroscopic repair of the rotator cuff.
- Primary Outcome Measures
Name Time Method Oxford Shoulder Score 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.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Schulthess Klinik
🇨🇭Zürich, Canton Zürich, Switzerland