Randomized clinical trial (RCT), Knee osteoarthritis

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.

The purpose of this randomized, controlled, multicenter, non-inferiority clinical trial was to compare the efficacy and safety of the combination of PRP and non-crosslinked hyaluronic acid (Cellular Matrix® A-CP-HA, Regen Lab, Switzerland,) as a single injection versus Hylan G-F 20 (HA), with follow-up at 1, 3 and 6 months, in knee osteoarthritis.

156 patients [ 40-80 years old with symptomatic femorotibial KOA [ WOMAC A1 (pain on walking) or WOMAC Function > 50/100 and a Kellgren and Lawrence radiographic stage II or III ] were randomized into two groups: Cellular Matrix® A-CP-HA or HA. The primary endpoint was the difference in the WOMAC score for pain on walking between M0 and M6 between the 2 groups. Secondary endpoints were collected and compared at M1, M3, and M6 (WOMAC Pain, Function, and Total; SF-36 score) as well as the percentage of patients responding at M6 according to the OMERACT-OARSI criteria [ Patient Acceptable Symptomatic State (PASS), and the Minimal Clinical Important Improvement (MCII) of the WOMAC pain ].

The symptomatic improvement (WOMAC pain, function and WOMAC Total) was significant in both groups at M1, M3 and M6 compared to M0. The difference in WOMAC A between M0 and M6 was significant for the non-inferiority test (-6.34 [-12.51; -0.18], p=0.044) and for the superiority test (-6.34 [-12.45; -0.22], p=0.042) in favor of Cellular Matrix® A-CP-HA. At M6, there was a non-significant difference in terms of OMERACT-OARSI responders in favor of the PRP-HA combination (58% vs. 48%, p=0.261) but significant in terms of MCII responders (78.8% vs. 61.3%, p=0.036) and PASS responders (50.6% vs. 33.3%, p=0.035). There was no difference in patient satisfaction score at M1, M3 and M6, nor in the occurrence of adverse events.

The authors concluded that in this non-inferiority RCT in symptomatic knee osteoarthritis, Cellular Matrix® A-CP-HA in mono-injection was at least equivalent to Hylan G-F 20 for symptomatic benefit (WOMAC) at 6 months, with a good safety profile. The proportion of patients achieving PASS and MCII of WOMAC pain was higher in the Cellular Matrix® A-CP-HA group.

Abstract POS1117: https://track.biobridge-event.com/e/915601/mdis-81-Suppl-1-886-2-full-pdf/hp4sw/136381790?h=IKnzh49Li_LuWDdwNyeuyM8j-ipz1RWdpCWKdpkIvtE