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General Orthopaedics

A PROSPECTIVE RANDOMISED CONTROLLED CLINICAL TRIAL COMPARING THE EFFICACY OF HYLAN G-F 20 AND SODIUM HYALURONATE IN THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE

British Orthopaedic Association (BOA) 2006



Abstract

Aim

To compare the clinical effectiveness, functional outcome and patient satisfaction following intra articular injection with Synvisc¯ and Hyalgan¯ in patients with osteoarthritis (OA) of the knee.

Methods

348 consecutive patients were randomised into two groups to receive either Hylan G-F 20 -Synvisc (n= 181) or Sodium Hyaluronate -Hyalgan (n=167). All patients were prospectively reviewed by independent assessors blinded for the treatment. Knee pain on a VAS were recorded. The functional outcome was assessed using Tegner, UCLA, Oxford knee score and EuroQol-5D scores. VAS was used to quantify patient satisfaction. Mean follow-up was 12 months.

Results

Mean age 66.7 yrs. Patients predominantly had grade III OA. Knee pain 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 Hyalgan 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). Similarly, the Tegner, UCLA and Oxford knee scores were significantly better in the Synvisc group at 6 weeks (p=0.02) and 6 months (p=0.03) and 12 months (p=0.04). EQ-5D description scores were higher in the Synvisc group at 6 months (p=0.03) and 1 year (p=0.04). There was local increase in knee pain in one patient (Synvisc), which settled by 4 weeks. Patient compliance was 99.2% in the Synvisc group as compared to 92.2% in the Hyalgan. Treatment cost was 23% more in the Hyalgan group.

Conclusion

Although both treatments offered significant pain reduction, it was earlier and sustained for a longer period in patients with Synvisc. Patients treated with Synvisc have demonstrated an early increase in activity levels. Local reaction of pseudo sepsis was observed with Synvisc in one patient. Total treatment cost, both for patient and hospital, is higher with Hyalgan.