Evaluate the efficacy of intra-articular hyaluronan (Synvisc(R)) to reduce pain and improve function in people with hallux limitus

Efficacy of intra-articular hyaluronan (Synvisc(R)) for the treatment of osteoarthritis affecting the first metatarsophalangeal joint of the foot (hallux limitus): study protocol for a randomised placebo controlled trial.

Article specifications

This clinical study was published in 2009 in Journal of J Foot Ankle Res. (IF 2009:0.76) by Australian specialists. This article describes the design of a randomised placebo controlled trial to evaluate the efficacy of intra-articular hyaluronan (Synvisc(R)) to reduce pain and improve function in people with hallux limitus. One hundred and fifty community-dwelling men and women aged 18 years and over with hallux limitus (who satisfy inclusion and exclusion criteria) will be recruited. Participants will be randomised, using a computer-generated random number sequence, to receive a single intra-articular injection of up to 1 ml hyaluronan (Synvisc(R)) or sterile saline (placebo) into the first MPJ.

 

Result

This study is the first randomised placebo controlled trial to evaluate the efficacy of intra-articular hyaluronan (Synvisc(R)) for the treatment of osteoarthritis of the first MPJ (hallux limitus). The study has been pragmatically designed to ensure that the study findings can be implemented into clinical practice if this form of treatment is found to be an effective treatment strategy.