Comparison of different dose regimens of intra-articular HA injections in the osteoarthritic ankle joint

Intra-articular sodium hyaluronate injections in the osteoarthritic ankle joint: Effects, safety and dose dependency.

Article specifications

This prospective randomized single blinded clinical trial was published in 2010 Foot and ankle surgery (IF 2010:1.147) by Dutch orthopedics. In this study the effects, safety and dose dependency of intra-articular hyaluronic acid injection in patients with ankle osteoarthritis were evaluated.  26 Patients, 18 male and 8 female with a median age of 46 (range 21–84) years were randomised to one of the four treatment groups. At baseline (week 0) four dosages were randomly allocated from the storage at the outpatient clinic and injected Orthovisc in the ankle joint, i.e. 1, 2, 3 ml, and 3 weekly injections of 1 ml (3× 1 ml). Follow-up evaluations were performed at 7, 15 and 27 weeks after the (first) injection.

Results

The results suggest that intra-articular injections of the ankle joint with HA result in pain reduction, with superior results for the 3_ 1 ml regimen compared to single dosages of 1, 2 and 3 ml. Most apparent improvement was observed for the primary outcome measure ‘pain during walking activities’. Additionally, in the 3_ 1 ml, categorical analysis of the 4-point scale of ‘general pain’ showed that the number of patients who experienced improvement was major compared to that of the single dose groups at all time intervals, though not always statistically significant. The 3× 1 ml dose group showed statistically significant decreases at week 7 for ‘pain during walking’ and ‘pain at rest’. At week 15 decreases were significant for ‘pain at rest’. There was no significant decrease of VAS-scores in any of the single dose groups. Seven patients experienced temporary local swelling and increased pain in the injected ankle. In conclusion, the results of this study indicate that high molecular weight hyaluronic acid (Orthovisc1) can be injected safely in the ankle joint and pain relief is observed with a 3-weekly dose regimen of 1 ml. The treatment shows potential to result in short-term (7 weeks) as well as long-term (27 weeks) pain reduction. This study showed no effectiveness for a single dose application for Orthovisc1.