Clinical Trials Directory

Trials / Completed

CompletedNCT01266226

Effect of ACP on Surgical Repair of Rotator Cuff Tears

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
129 (actual)
Sponsor
Schulthess Klinik · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DEVICEAutologous conditioned plasma4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
DEVICEControl group4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.

Timeline

Start date
2010-12-01
Primary completion
2013-02-01
Completion
2015-02-01
First posted
2010-12-24
Last updated
2015-05-20

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT01266226. Inclusion in this directory is not an endorsement.