Effect of ACP on Surgical Repair of Rotator Cuff Tears
|ClinicalTrials.gov Identifier: NCT01266226|
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : May 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tears||Device: Autologous conditioned plasma Device: Control group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2015|
Experimental: ACP treated
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
4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
Other Name: ACP Arthrex
Placebo Comparator: Control group
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
4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.
Other Name: ACP Arthrex
- Oxford Shoulder Score [ 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.
- VAS Pain [ Time Frame: 10d po ]
- QuickDASH [ Time Frame: 3/6/24mo ]
- EQ-5D [ Time Frame: 3/6/24 mo ]
- ROM [ Time Frame: 3/6/24mo ]
- Measurement of the abduction strength [ Time Frame: 3/6/24 mo ]
- ASES Score [ Time Frame: 3/6/24mo ]
- Constant Murley Score [ Time Frame: 3/6/24 mo ]
- MRI/X-Ray/Ultrasonic Diagnostics [ Time Frame: 6/24 mo ]
- Measurement of the external rotation strenght [ Time Frame: 3/6/24 mo ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266226
|Zürich, Canton Zürich, Switzerland, 8008|
|Principal Investigator:||Matthias Flury, Dr||Upper Extremities Department|