The Knee
Volume 12, Issue 1 , Pages 57-62, January 2005

Intra-articular hylan G-F 20 (Synvisc®) in the management of patellofemoral osteoarthritis of the knee (POAK)

  • Shane Clarke

      Affiliations

    • Corresponding Author InformationCorresponding author. Tel.: +44-117-928-7263; fax: +44-117-928-7236.
    • Rheumatology Unit, University Department of Medicine, Bristol Royal Infirmary, Bristol BS2 8HW, UK
  • ,
  • Vanessa Lock

      Affiliations

    • Rheumatology Unit, University Department of Medicine, Bristol Royal Infirmary, Bristol BS2 8HW, UK
  • ,
  • John Duddy

      Affiliations

    • Rheumatology Unit, University Department of Medicine, Bristol Royal Infirmary, Bristol BS2 8HW, UK
  • ,
  • Mohammed Sharif

      Affiliations

    • Rheumatology Unit, University Department of Medicine, Bristol Royal Infirmary, Bristol BS2 8HW, UK
  • ,
  • John H. Newman

      Affiliations

    • Department of Orthopaedic Surgery, Bristol Royal Infirmary, Bristol BS2 8HW, UK
  • ,
  • John R. Kirwan

      Affiliations

    • Rheumatology Unit, University Department of Medicine, Bristol Royal Infirmary, Bristol BS2 8HW, UK

Received 1 November 2003; received in revised form 5 February 2004; accepted 14 March 2004. published online 19 August 2004.

Abstract 

The clinical effect of intra-articular viscosupplementation has been assessed in patients suffering tibiofemoral osteoarthritis and review of the data suggest pain relief extending to 12 months in such patients. There are no prospective trials of viscosupplementation targeting patients with patellofemoral osteoarthritis (POAK) of the knee, which is frequent, associated with anterior knee pain and often disabling. This pilot study addressed the therapeutic and adverse effects of intra-articular (IA) hylan in patients with evidence of lone POAK. Forty-three outpatients were recruited to receive a (three-injection) course of IA hylan G-F 20 (Synvisc). Patient and clinician global rating and pain on stair climbing improved significantly from 4 weeks post initial injection to 26 weeks. Secondary outcome measures (including the Oxford Knee Outcome Score) were also recorded. Adverse knee events occurred in 18.6% of patients within 48 h, but only two failed to complete the course of injections because of adverse knee events. One hundred and four patients would be required for a randomised controlled trial of IA hylan to effectively demonstrate an effect size of 0.5 (a 15-mm difference between placebo and treatment arm over a 100-mm visual analogue pain scale) with 95% confidence and 90% power, to detect a 15-mm change in VAS (effect size 0.5) with 95% confidence and 90% power. This would require a RCT of 104 patients to detect a 15-mm change in VAS (effect size 0.5) with 95% confidence and 90% power.

Keywords:  Knee, Patellofemoral Osteoarthritis, Viscosupplementation, Hylans

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PII: S0968-0160(04)00076-6

doi:10.1016/j.knee.2004.03.002

The Knee
Volume 12, Issue 1 , Pages 57-62, January 2005