THE EFFICACY OF HYLAN G-F 20 AND SODIUM HYALURONATE IN THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE – A PROSPECTIVE RANDOMIZED CLINICAL TRIAL

Abstract

Aim: To compare the clinical effectiveness, functional outcome and patient satisfaction following intra articular injection with Hylan G-F-20 and Sodium Hyaluro-nate in patients with osteoarthritis (OA) of the knee.

Methods: In this independent study, 382 consecutive patients with OA of the knee were prospectively randomized into two groups to receive Hylan G-F-20 -Syn-visc (n=196) or Sodium Hyaluronate -Hyalgan (n=186) and reviewed by blinded independent assessors at pre injection, 6 weeks, 3, 6, 12 months. Knee pain, patient satisfaction was measured on a VAS. Functional outcome was assessed using WOMAC, UCLA, Tegner, Oxford knee score and EuroQol- 5D scores. Mean follow up was 14 months.

Results: Patients in both groups predominantly had grade III OA. Knee pain on VAS improved from 6.7 to 3.2 by 6 weeks (p=0.02) and was sustained until 12 months (3.7, p=0.04) with Synvisc. In the Hyal-gan group, pain improved from 6.6 to 5.7 at 6 weeks (p> 0.05) and to 4.1 at 3 months (p=0.04) but was sustained only until 6 months (5.9, p> 0.05). Improvements in the WOMAC pain and physical activity subscales were significantly superior in the Synvisc group at 3 months (p=0.02), 6 months (p=0.01) and 12 months (p=0.02). General patient satisfaction was better in the Synvisc group at all times although statistically significant at 3 months (p=0.01) and 6 months (p=0.02). There was local increase in knee pain in one patient who received Synvisc, which settled by 4 weeks. Total treatment cost was 23% more in the Hyalgan group due to the two additional visits.

Conclusion: Although both treatments offered significant pain reduction, it was achieved earlier and sustained for a longer period in patients with Synvisc with early increase in activity levels. However, a local reaction of pseudo sepsis was observed with Synvisc in one patient. The total treatment cost, both for the patient and the hospital are higher with Hyalgan. From this study, it appears that the clinical effectiveness and general patient satisfaction are better amongst patients who received Synvisc.