Effect of ACP on Surgical Repair of Rotator Cuff Tears

Schulthess Klinik

Status: Completed

Conditions: Rotator Cuff Tears

Treatments: Device: Control group; Device: Autologous conditioned plasma

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01266226

KEK-ZH-Nr. 2010-0309/4 (Other Identifier)

ACP01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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129 participants in 2 patient groups, including a placebo group

ACP treated

Experimental group

Description:

The patients are going to get an injection of 4mL autologous conditioned plasma under the footprint following an arthroscopic repair of the rotator cuff.

Treatment:

Device: Autologous conditioned plasma

Control group

Placebo Comparator group

Description:

The patients are going to get an injection of 4mL saline solution under the footprint following an arthroscopic repair of the rotator cuff.

Treatment:

Device: Control group