Efficacy of Three Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Function in Patients With Knee Osteoarthritis (OA)
Condition: Hyaluronate; Osteoarthritis; Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated, provide rapid
      pain relief as early as 1 and 2 weeks after the first injection, and improve function in
      patients with knee osteoarthritis. The treatment effects can last for 6 months.
    

Detailed description: 
      Background: Viscosupplementation with intra-articular hyaluronate injections is a safe and
      effective treatment of knee osteoarthritis. There are several forms of hyaluronate with
      different origin, method of production, molecular weight, dosing instructions and possibly
      clinical outcomes. Most current hyaluronate products are avian in origin, and only few are
      bioengineered via bacterial fermentation. The purpose of this study was to evaluate the
      efficacy and safety of 3 weekly injections of a bacterial-sourced hyaluronate (Hya-Joint) in
      patients with knee osteoarthritis.

      Methods: As a prospective randomized observer-blind study done in a university-affiliated
      tertiary care medical center, patients with knee osteoarthritis for at least 6 months were
      enrolled. Eligible patients were randomized to receive three weekly intraarticular injections
      of either bacterial-sourced hyaluronate (Hya-Joint) or avian-derived hyaluronate (Hyalgan)
      into the target knee. The primary outcome was the visual analog scale (VAS) change from
      baseline for knee pain at 6-month follow-up. Secondary outcome measures included Lequesne
      index, timed up and go test (TUG), patients' global satisfaction and analgesics consumption.

      Results: A total of 95 participants were randomly assigned and 89 participants completed the
      study. Both groups had significant improvements in pain as early as 1 and 2 weeks after the
      first injection, and the pain-reduction effects could last for 6 months, with no
      between-group differences. The Lequesne index scores and results of TUG tests improved
      significantly from baseline in both group at all follow-up visits (p<0.001 for each test
      compared with baseline), with no significant between-group differences at 1-month and 6-month
      follow-up. However, significantly greater improvements favoring the Hya-Joint group were
      noted at 3-month follow-up (p<0.05). No between-group differences were seen regarding the use
      of analgesics. Both groups reported high satisfaction at 6-month follow-up. No serious
      adverse events occurred.

      Conclusions: Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated,
      provide rapid pain relief as early as 1 and 2 weeks after the first injection, and improve
      function in patients with knee osteoarthritis. The treatment effects can last for 6 months.
    

Intervention name(s): Hya-Joint; Hyalgan
Intervention type(s): Procedure; Procedure
Intervention description(s): The Hya-Joint group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hya-Joint, derived from Streptococcus zooepidemicus and produced by a highly purified biologic fermentation process, molecular weight 650-1200 kDa),into the target knee.; The control group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan, extracted from chicken combs, molecular weight 500-730kDa) into the knee joints.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Balance; Hyaluronate; Osteoarthritis; Viscosupplementation