Validation of a Low-cost Platelet-Rich Plasma (PRP)

Study Summary

Knee osteoarthritis is an extremely common and debilitating condition, more common in women, with an estimated global prevalence of 16%, and as high as 50% by the age of 80. Current management of knee osteoarthritis (OA) revolves around conservative treatments- biomechanical interventions, intra-articular injections, exercise, self-management and education, oral or topical medications, strength training, and weight management - or surgical management. For injection therapies, corticosteroids remain the standard of care; approximately 84% of sports medicine physicians perform these knee injections at least monthly, reporting a median range of 11-20 injections per month. Multiple detrimental effects of corticosteroid injections are well-known, including alterations of the hypothalamic-pituitary-adrenal axis, blood glucose levels, bone turnover, inflammatory response, blood pressure, and psychologic well-being. Thus, alternative therapies are of the utmost importance. Platelet-Rich Plasma (PRP) is an injectable preparation of a patient's blood that can be used for numerous conditions and has received significant attention over the past several years for its potential application for the treatment of pain and functional impairment due to knee OA. Systematic reviews of randomized-controlled trials have demonstrated equivalent-to-superior treatment outcomes associated with the use of intra-articular PRP compared to placebo, hyaluronic acid, and corticosteroid. Furthermore, use of intra-articular PRP is associated with a very low rate of adverse events and is likely safer than injectable corticosteroids. Concerns that have limited a wider use of PRP include two main concerns - an uncertainty regarding the current evidence base due to study-related bias, heterogeneity, and lack of reporting standards; and second, more importantly, the main issue remains high cost.

Primary Outcome

The primary goal of this study is to validate the investigator(s) easy-to-replicate LC-PRP preparation technique to demonstrate that its composition is equivalent to standard, commercially-available PRP preparation kits. The investigators will specifically compare the quantity of platelets derived from their system compared to previously published platelet counts for commercially available PRP preparation kits.

Interventions

• PROCEDURE Intra-Articular knee injection of LC-PRP