Effect of ACP on Surgical Repair of Rotator Cuff Tears

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Device: Autologous conditioned plasma
* Device: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACP treated<br>The patients are going to get an injection of 4mL autologous conditioned plasma under the footprint following an arthroscopic repair of the rotator cuff. | Device: Autologous conditioned plasma<br>* 4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.<br>* Other names: ACP Arthrex;|
| Placebo Comparator: Control group<br>The patients are going to get an injection of 4mL saline solution under the footprint following an arthroscopic repair of the rotator cuff. | Device: Control group<br>* 4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.<br>* Other names: ACP Arthrex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Shoulder Score | 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. | 3mo (6mo/24mo) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Pain |  | 10d po | 
| QuickDASH |  | 3/6/24mo | 
| EQ-5D |  | 3/6/24 mo | 
| ROM |  | 3/6/24mo | 
| Measurement of the abduction strength |  | 3/6/24 mo | 
| ASES Score |  | 3/6/24mo | 
| Constant Murley Score |  | 3/6/24 mo | 
| MRI/X-Ray/Ultrasonic Diagnostics |  | 6/24 mo | 
| Measurement of the external rotation strenght |  | 3/6/24 mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator cuff tears, ACP