The Multiple Dosing Effects of Platelet-Rich Plasma on Cartilage Regeneration in Knee Osteoarthritis: Randomised, Placebo-Controlled Trial

Abstract

Introduction: The purpose of this study was to evaluate clinical and biochemical efficacy of autologous intra-articular (IA) platelet rich plasma (PRP) compared to saline and to measure effectiveness of single and multiple doses given at monthly intervals for Kellgren-Lawrence (K-L) grade II, III knee osteoarthritis (KOA). Materials and methods: A total of 130 patients were randomised into 4 groups; PRP-1 (n=36), PRP-2 (n=34), PRP-3 (n=32) and saline (NS) (n=28), after approval from institute ethics committee (reference number: TMU/IEC/20-21/091) and was conducted in accordance with Helsinki declaration. Groups PRP-1, PRP-2, PRP-3 received single, double and triple injections of PRP whereas NS group received single saline (0.9%) injection. Assessment of outcome scores (visual analogue scale [VAS] and Western Ontario and McMaster Universities Arthritis Index [WOMAC]) was done at baseline and three, six, nine months post intervention. Serum collagen 2-1 (Coll2-1) estimation at baseline and nine months post-therapy was used for biochemical assessment. Results: Improvement in VAS and WOMAC was statistically significant and clinically meaningful (Minimal clinically important change [MCIC]; >12% of baseline and ≥2cm difference in mean for WOMAC and VAS, respectively) for groups PRP-1, PRP-2 and PRP-3 in comparison to saline (P<0.05), at every follow-up. PRP groups also exhibited a significant decrease in serum Coll2-1 at 9 months (P<0.05). On comparison among the PRP groups, multiple doses (groups PRP-2 and PRP-3) produced significantly better clinical results than single dose (group PRP-1) (P<0.05), whereas the difference in Coll2-1 levels was significant for group PRP-1 vs PRP-3 only (P<0.05). Conclusion: PRP results in clinically significant amelioration of functional and pain scores as well as significant reduction in serum levels of Coll2-1 in K-L grade II, III KOA over nine months. These benefits can be accentuated by multiple doses given one month apart.