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| Name | Class |
|---|---|
| Arthrex, Inc. | INDUSTRY |
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Rotator cuff tears are a common injury that lead to pain and loss of function for those who suffer from it. Treatment includes the use of arthroscopic surgery to return function to the patient and reduce their pain. This study is interested in a technique that has the potential to improve patient outcomes in terms of less pain and better function after their surgery. Autologous Conditioned Plasma (ACP) or Platelet Rich Plasma (PRP) is the intervention of interest, which is simply the patient's own blood that is withdrawn and spun down to obtain a high concentration of cells called platelets. Platelets release growth factors important for healing, as well as fibrin, which acts like a biological glue. The PRP is then re-injected into the shoulder at the time of surgery and again at 4 weeks. It has been shown to accelerate healing in other studies for injuries such as chronic elbow tendinopathy, but there is no randomized controlled trial that evaluates the effect of PRP in rotator cuff tears. It is on this basis that the study is being performed. Participating patients will receive either a PRP injection or a placebo (normal saline) and the effects will be compared at 2 weeks, 4 weeks, and 6 weeks based on a pain score and return to function questionnaires. The primary hypothesis for this study is that ACP compared with placebo is effective in reducing pain at the site of a rotator cuff injury that has undergone arthroscopic repair. It is expected that ACP administered during surgery and 4 weeks post-surgery will reduce 6-week pain scores compared to the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous conditioned plasma | Active Comparator |
| |
| Normal saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous conditioned plasma (ACP) | Biological | ACP is not a drug as the patient's own blood plasma is re-injected into the surgical site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | To investigate the effect of ACP compared to placebo on pain scores in rotator cuff tears undergoing arthroscopic repair at 6 weeks. Pain severity will be measured using a Visual Analog Scale (VAS). Subjects will be asked to rate their worst pain in their shoulder for the previous 24 hours on a 100 mm vertical scale with "0" indicating no pain at all and "100" indicating the worst pain the subject can imagine. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function | As measured by the Western Ontario Rotator Cuff Index (WORC), the Disabilities of the Arm, Shoulder and Hand Score (DASH), and the Constant Score, administered prior to the surgical intervention, and at 2 weeks, 4 weeks and 6 weeks post-surgery. | Up to and including 6 weeks |
| Revision surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohit Bhandari, MD, MSc, PhD, FRCSC | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8L8E7 | Canada | ||
| Hamilton General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20141991 | Background | Lopez-Vidriero E, Goulding KA, Simon DA, Sanchez M, Johnson DH. The use of platelet-rich plasma in arthroscopy and sports medicine: optimizing the healing environment. Arthroscopy. 2010 Feb;26(2):269-78. doi: 10.1016/j.arthro.2009.11.015. | |
| 18608363 | Background | Randelli PS, Arrigoni P, Cabitza P, Volpi P, Maffulli N. Autologous platelet rich plasma for arthroscopic rotator cuff repair. A pilot study. Disabil Rehabil. 2008;30(20-22):1584-9. doi: 10.1080/09638280801906081. |
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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 |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Normal saline | Other | Normal saline injection |
|
| Up to and including 6 weeks |
| Health utility | As measured by the EuroQol-5 Dimensions (EQ-5D) administered prior to the surgical intervention, and at 2 weeks, 4 weeks and 6 weeks post-surgery. | Up to and including 6 weeks |
| Adverse events | Up to and including 6 weeks |
| Hamilton |
| Ontario |
| Canada |
| McMaster Hospital | Hamilton | Ontario | Canada |
| 20068208 | Background | de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986. |