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| ID | Type | Description | Link |
|---|---|---|---|
| KEK-ZH-Nr. 2010-0309/4 | Other Identifier | Regional Ethics Committee of Zurich |
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| Name | Class |
|---|---|
| Arthrex, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACP treated | Experimental | The patients are going to get an injection of 4mL autologous conditioned plasma under the footprint following an arthroscopic repair of the rotator cuff. |
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| Control group | Placebo Comparator | The patients are going to get an injection of 4mL saline solution under the footprint following an arthroscopic repair of the rotator cuff. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous conditioned plasma | Device | 4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Shoulder Score | 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. | 3mo (6mo/24mo) |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Pain | 10d po | |
| QuickDASH | 3/6/24mo | |
| EQ-5D |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Flury, Dr | Upper Extremities Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schulthess Klinik | Zurich | Canton Zürich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27184542 | Derived | Flury M, Rickenbacher D, Schwyzer HK, Jung C, Schneider MM, Stahnke K, Goldhahn J, Audige L. Does Pure Platelet-Rich Plasma Affect Postoperative Clinical Outcomes After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial. Am J Sports Med. 2016 Aug;44(8):2136-46. doi: 10.1177/0363546516645518. Epub 2016 May 16. |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Device | 4mL saline application under the footprint following an arthroscopic repair of the rotator cuff. |
|
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| 3/6/24 mo |
| ROM | 3/6/24mo |
| Measurement of the abduction strength | 3/6/24 mo |
| ASES Score | 3/6/24mo |
| Constant Murley Score | 3/6/24 mo |
| MRI/X-Ray/Ultrasonic Diagnostics | 6/24 mo |
| Measurement of the external rotation strenght | 3/6/24 mo |
| D008722 | Methods |