Schulthess Klinik
Zurich, Canton Zürich, 8008, Switzerland
NCT Number: NCT01266226
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Zurich, Canton Zürich, 8008, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
Other names: ACP Arthrex
4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.
Other names: ACP Arthrex
Time frame: 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.
Time frame: 10d po
Time frame: 3/6/24mo
Time frame: 3/6/24 mo
Time frame: 3/6/24mo
Time frame: 3/6/24 mo
Time frame: 3/6/24mo
Time frame: 3/6/24 mo
Time frame: 6/24 mo
Time frame: 3/6/24 mo
Schulthess Klinik
Other
Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears
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