Intra-Articular Hyaluronan Treatment of Patients with Knee Osteoarthri- tis Waiting for Replacement Surgery

Aim: To determine whether hyaluronan (HA) delays and/or reduces the knee replacement surgery (KRS) in patients with osteoarthritis (OA). Material and Methods: A prospective, single-center, double-blind, randomized, placebo-controlled, pilot clinical trial with two treatment groups [HA (Adant ® ) treatment group and placebo treatment group] was conducted. The intra-articular treatments (HA or placebo) consisted of two cycles of five weekly injections with a 24-week interval between each cycle. The efficacy variable was determined by change in pain, articular mobility and functional capacity as measured by WOMAC. All efficacy variables have been analyzed for the intention-to-treat population. Results: 52 patients (10M/42F) were enrolled in the study (HA group: 26; placebo group: 26). Time until KRS in the HA group subjects (368.8 days) was longer than that in the placebo group (253.9 days). The change in the WOMAC stiffness subscale at 24 weeks, compared to the baseline score, was –22.4 in the HA group and -2.2 in the placebo group (p = 0.081). The change in the physical function WOMAC subscale, compared to the baseline score, was statistically significant at 24 weeks (HA group = -24.7 placebo group = -4.4 p = 0.019). Similar results were found in the change in the total WOMAC index score (HA group = -23.9 vs placebo group = -5.6 p = 0.044). Conclusion: The use of intra-articular HA to treat OA patients on the waiting list for KRS does not delay surgery. However, it could improve the physical condition of patients while they are waiting by surgery.