Rotator Cuff Tears Clinical Trial
Official title:
Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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