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OP0008 Structure modification in osteoarthritis with intra-articular sodium hyaluronate of mol. 500–730 kda
  1. RW Jubb1,
  2. S Piva2,
  3. L Beinat2,
  4. J Dacre3,
  5. P Gishen4 On behalf of the UK Hyalgan Study Group
  1. 1Rheumatology Department, UHB Trust, Birmingham
  2. 2Medical Department, Fidia SpA, Abano Terme, Italy
  3. 3UCL London
  4. 4Radiology Department, King’s College Hospital, London, UK

Abstract

Background Several Hyaluronan based products are available for intra-articular administration. These products differ in their composition and contain either natural hyaluronan of differing molecular weight or chemically crosslinked hyaluronan. Numerous clinical studies have shown that a series of 3–5 weekly intra-articular injections of hyaluronan of molecular weight 500–730 kDa (Hyalgan) reduces pain and improves function in patients with osteoarthritis of the knee and that this effect can be long lasting (6–12 months). Moreover, there is some evidence from pilot clinical studies to suggest that this product may slow osteoarthritis.

Objectives The primary objective of the present study was to examine the structure-modifying activity of intra-articular hyaluronan of molecular weight 500–730 kDa.(Hyalgan).

Methods A multicentre, randomised, placebo-controlled, double-blind (masked observer) study in patients with primary knee osteoarthritis (ACR criteria) was conducted in 17 centres in the UK. The primary end point was the change in radiological joint space between baseline and one year in the medial tibio-femoral compartment, measured by digital image analysis. Weight-bearing antero-posterior radiographs were taken using a standardised technique. Patients were randomly assigned to receive 3 courses of 3 intra-articular injections of hyaluronan or 2 ml of placebo (saline solution) during the one year study. Uncontrolled use of analgesics and NSAIDs were allowed.

Results 408 patients with knee osteoarthritis (II-III Kellgren-Lawrence) were enrolled in the trial and 319 patients completed the one year study period. Mean patient age was 64.2 yrs (sd = 9.3), 68.4% of patients were female. The two groups, placebo and control, were comparable at entry for disease state and demographics. The change in joint space width between baseline and one year in the two groups was compared by analysis of variance. The group of patients with greater joint space at entry, treated with hyaluronan, showed statistically reduced progression of joint space narrowing. In the hyaluronan group the mean loss was only -0.22 (sd = 1.1), while in the placebo group the mean loss was -0.60 (sd = 1.1). This was statistically significant, p < 0.05.

Conclusion Repeat treatment cycles of intra-articular hyaluronan of molecular weight 500–730 kDa (Hyalgan) result in a statistically significant delay in radiological joint space narrowing within one year, in patients with osteoarthritis of the knee.

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