A multi-centre, open label, long-term follow-up study to evaluate the benefits of a new viscoelastic hydrogel (Hymovis (R)) in the treatment of knee osteoarthritis

作者：Benazzo F; Perticarini L^*; Padolino A; Castelli A; Gifuni P; Lovato M; Manzini C; Giordan N

来源：European Review for Medical and Pharmacological Sciences, 2016, 20(5): 959-968.

• Knee
• Osteoarthritis
• Hyaluronic acid
• Viscosupplementation

OBJECTIVE: To evaluate the long-term efficacy and safety of Hymovis (R) in the symptomatic treatment of knee osteoarthritis (OA).
PATIENTS AND METHODS: This is a prospective, multi-center, open label, phase III clinical study. Two intra-articular injections (3 mL) of Hymovis (R) (8 mg/mL HYADD (R) 4) were administered 1 week apart at the beginning of the study on day 0 and day 7 and after 6 months from baseline, on day 182 and 189. Follow-up assessment were conducted for 52 weeks. 50 subjects, > 40 years old, with knee OA, with clinical and radiological confirm, complain pain in the target knee were enrolled. The variables considered were: WOMAC questionnaire, Joint Space Width (JSW), OMERACT OARSI responder criteria, EQ-5D questionnaire, rescue medication consumption.
RESULTS: After the injections of Hymovis (R), pain perceived by the patient when walking on a flat surface (WOMAC A1 score) significantly improves at the end of the study respect to the baseline. WOMAC stiffness, physical function and total score significantly improve during the study since 3 months after treatment, and it is maintained up to the end of the study (p < 0.001). By the x-ray analysis of knee, a radiological progression of OA was observed in the 26% of patients at the end of the study, while 88% of patients result to be responder to the therapy classified as per OMERACT-OARSI criteria. The EQ-5D weighted index increased significantly, against baseline, at each study time point (p < 0.001). Investigator's and patient's global assessment of the disease measured by the VAS both show a marked improvement in patient's health conditions.
CONCLUSIONS: Results from this study confirm that Hymovis (R) alleviate the knee pain since the first treatment cycle. The patients treated with two cycles of intra-articular injections of Hymovis (R) have a progressive pain reduction that is maintained up to one year after the treatment start with improve of all the scores considered in this study. Hymovis (R) is effective and safe in symptomatic treatment of painful knee OA.

• 出版日期2016-3