POS1115 EFFICACY AND SAFETY OF THE COMBINATION OF PRP + NON-CROSSLINKED HYALURONIC ACID VERSUS HYALURONIC ACID, IN MONO-INJECTION, IN SYMPTOMATIC KNEE OSTEOARTHRITIS. RANDOMIZED CONTROLLED PHASE III TRIAL, SINGLE BLIND

Background Despite the recent results of meta-analyses randomized controlled trials (RCTs), place PRP and hyaluronic acid in symptomatic treatment knee osteoarthritis (KOA) remains uncertain latest international recommendations. Very few studies are available on potential synergistic effect their combination mild to moderate forms KOA (1) . Objectives Randomized, controlled, multicenter, non-inferiority trial ( clinical NCT03328728 ), single-blinded (investigator) compare efficacy safety non-crosslinked (PRP-HA, Cellular Matrix A-CP-HA , Regen Lab ) as a single injection versus Hylan G-F 20 (HA), with follow-up at 1, 3 6 months, an intention-to-treat (ITT) basis. Methods Patients aged 40-80 years femorotibial (WOMAC A1 (pain walking) or WOMAC Function > 50/100) Kellgren Lawrence (KL) radiographic stage II III were into two groups: PRP-HA vs. HA, radio- ultrasound-guided M0. should not have received injectable treatments (corticosteroids, HA PRP) for nor per os NSAIDs least 1 month. A 6-month impact was performed M1, M3 M6. The primary endpoint difference score pain walking between M0 M6 2 groups. Secondary endpoints collected compared M3, Pain, Function, Total; SF-36 score) well percentage patients responding according OMERACT-OARSI criteria, Patient Acceptable Symptomatic State (PASS), Minimal Clinical Important Improvement (MCII) pain. factors good response (PASS MCII responders) investigated univariate multivariate analysis. Tolerance assessed by comparing adverse events over months both Results 156 included three French teaching hospitals 2018 2021 following characteristics: age 59.6±9.2 years, BMI 28.1±5.8 kg/m 37.8% grade KL 62.2% KL. groups homogeneous inclusion except terms analgesic consumption (PRP-HA 30% 45%, p=0.042) (70% 53%, p=0.04). improvement pain, function Total) significant test (-6.34 [-12.51; -0.18], p=0.044) superiority [-12.45; -0.22], favor PRP-HA. At M6, there non-significant responders (58% 48%, p=0.261) but (78.8% 61.3%, p=0.036) PASS (50.6% 33.3%, p=0.035).PASS associated analysis total (p<0.001) allocated (p=0.03). In analysis, only (PRP+HA, OR=2.05 [1.02-3.92]; p=0.05) OR=2.21 [1.09-4.44]; p=0.02). There no patient satisfaction occurrence events. Conclusion this RCT osteoarthritis, PRP-non-crosslinked mono-injection equivalent benefit (WOMAC) profile. proportion achieving higher group. References [1] Comparing dual Platelet-Rich Plasma (PRP) Hyaluronic Acid (HA) therapy PRP-alone osteoarthritis: systematic review meta-analysis. Aw AAL, Leeu JJ, Tao X, Bin Abd Razak HR.J Exp Orthop. Nov 4;8(1):101. doi: 10.1186/s40634-021-00415-1. Disclosure Interests thomas delgado: None declared, Rosanna Ferreira Lopez: Philippe Adam Speakers bureau: regenLab, Consultant of: Yves-Marie Pers: Leila Benguella: catherine cyteval: valerie de fourmestraux Employee RegenLab, Sandrine Lombion Paid instructor for: Paul Ornetti Grant/research support from: regenLab