Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle.

BACKGROUND

The potential benefit of hyaluronans in alleviating pain associated with osteoarthritis (OA) in joints other than the knee is of increasing interest. This double-blind, randomized, controlled study examined the safety and efficacy of intraarticular sodium hyaluronate (Hyalgan) in the treatment of pain associated with ankle OA.

MATERIALS AND

METHODS

Thirty consecutive patients with ankle OA documented by X-ray were randomized to treatment with five weekly injections of either sodium hyaluronate 2 mL (HYL) or phosphate-buffered saline 2 mL (control) in the tibiotalar joint. The primary endpoint was pain on movement and weightbearing using the Ankle Osteoarthritis Scale (AOS) 3 months after injection (a 100-mm visual analog scale [VAS]). Additional measures included the Western Ontario and McMaster Universities (WOMAC) OA Index and patient global assessment through 6 months; the Short Form-12 (SF-12) Health Survey at 3 months and 6 months; and all reported adverse events (AEs).

RESULTS

The study groups differed only in age, baseline WOMAC pain, and AOS total scores; 80% of the HYL and 73% of the control patients completed the study. At Month 3, the primary endpoint of the study, the HYL group demonstrated a significantly greater improvement from baseline in AOS total score than did the control group (HYL: -17.4 +/- 5.0 mm;

CONTROL: -5.1 +/- 4.0 mm; p = 0.0407). The incidence of AEs was low, with no significant differences between the groups. There were no post-injection flares.

CONCLUSION

Our study suggests that sodium hyaluronate may be a safe and effective option for pain associated with ankle OA, although larger studies are needed.