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
| Type | Name | Description |
|---|---|---|
| DEVICE | Autologous conditioned plasma | 4mL autologous conditioned plasma application 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. |
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.