The safety and efficacy of intra-articular dual molecular weighted hyaluronic acid in the treatment of knee osteoarthritis: the I.D.E.H.A. study

In clinical practice viscosupplementation with hyaluronic acid (HA) is common for the treatment of degenerative osteoarthritis (OA). Both molecular weight and concentration of HA have significant impact on its rheological properties, which in turn affects its therapeutic effects. The objective of this study is to evaluate the effectiveness of a double HA preparation for the treatment of knee osteoarthritis with respect to pain reduction, joint function improvement and concomitant medication consumption reduction. One thousand and fourteen patients (521 males and 693 females) with a mean age of 62.4 years old, suffering from OA of the knee, were enrolled into this study. All patients received two intra-articular injections one week apart and a third injection one month after the second one. Concomitant medication was recorded and evaluated at follow up visits. Evaluation was performed at baseline, day 30 and day 180, on several parameters: knee pain by visual analog scale (VAS) 0-10 cm, Lequesne Index, and consumption of concomitant medications including non-steroidal anti-inflammatory drugs, analgesics and chondoprotective supplementations. A statistically significant reduction in pain VAS score was recorded at D30 (38.01±17.68; P<0.01) before the third injection, and D180 (25.91±15.33; P<0.01) check-points comparing to baseline (67.12±15.99). Similarly, remarkable reduction in Lequesne Index was shown at D30 (5.91±4.01; P<0.01) in 1214 patients before the third injection, and D180 (3.59±3.45; P<0.01) (with 938 patients) when compared to the baseline (11.60±5.13). Patients also consumed less concomitant medications after the treatment course. The beneficial effects were maintained for up to six months. Intra-articular injection of a double HA preparation of low molecular weight and high molecular weight of different concentrations was well tolerated, and generated satisfactory results in terms of pain control, joint function improvement and concomitant medication reduction for the management of knee OA.