Effect of ACP on Surgical Repair of Rotator Cuff Tears

• VAS Pain [ Time Frame: 10d po ] [ Designated as safety issue: No ]
• QuickDASH [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
• EQ-5D [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
• ROM [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
• Measurement of the abduction strength [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
• ASES Score [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
• Constant Murley Score [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
• MRI/X-Ray/Ultrasonic Diagnostics [ Time Frame: 6/24 mo ] [ Designated as safety issue: No ]
• Measurement of the external rotation strenght [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]

• VAS Pain [ Time Frame: 10d po ] [ Designated as safety issue: No ]
• QuickDASH [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
• EQ-5D [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
• ROM [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
• Measurement of the abduction strenght [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
• ASES Score [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
• Constant Murley Score [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
• MRI/X-Ray/Ultrasonic Diagnostics [ Time Frame: 6/24 mo ] [ Designated as safety issue: No ]

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.

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.

• Device: Autologous conditioned plasma
  4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
  Other Name: ACP Arthrex
• Device: Control group
  4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.
  Other Name: ACP Arthrex

• Experimental: ACP treated
  The patients are going to get an injection of 4mL autologous conditioned plasma under the footprint following an arthroscopic repair of the rotator cuff.
  Intervention: Device: Autologous conditioned plasma
• Placebo Comparator: 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.
  Intervention: Device: Control group

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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