Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial

摘要

Purpose: To prospectively compare the efficacy of intra-articular injections of platelet-rich plasma (PRP) and hyaluronic acid (HA) with a sham control group (normal saline solution [NS]) for knee osteoarthritis in a randomized, dose-controlled, placebo-controlled, double-blind, triple-parallel clinical trial. Methods: A total of 87 osteoarthritic knees (53 patients) were randomly assigned to 1 of 3 groups receiving 3 weekly injections of either leukocyte-poor PRP (31 knees), HA (29 knees), or NS (27 knees). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and International Knee Documentation Committee (IKDC) subjective score were collected at baseline and at 1, 2, 6, and 12 months after treatment. Data were analyzed using generalized estimating equations. Results: All 3 groups showed statistically significant improvements in both outcome measures at 1 month; however, only the PRP group sustained the significant improvement in both the WOMAC score (63.71 +/- 20.67, increased by 21%) and IKDC score (49.93 +/- 17.74, increased by 40%) at 12 months. For the intergroup comparison, except for the first month, there was a statistically significant difference between the PRP and NS groups in both scores throughout the study duration (regression coefficients of 8.72 [P = .0015], 7.94 [P = .0155], and 11.92 [P = .0014] at 2, 6, and 12 months, respectively, for WOMAC score, and 9.1 [P = .0001], 10.28 [P = .0002], and 13.97 [P .0001], respectively, for IKDC score). There was no significant difference in both functional outcomes between the HA and NS groups at any time point. Only the PRP group reached the minimal clinically important difference in the WOMAC score at every evaluation (15%, 21%, 18%, and 21% at 1, 2, 6, and 12 months, respectively) and the minimal clinically important difference in the IKDC score at 6 months (improvement of 11.6). Conclusions: Intra-articular injections of leukocyte-poor PRP can provide clinically significant functional improvement for at least 1 year in patients with mild to moderate osteoarthritis of the knee.