The Effectiveness and Safety of Triple 2ml Hyaluronic Acid Intra-articular Injection (Suplasyn®) in Managing Symptomatic Primary Osteoarthritis of the Knee in Real-life Practice: ESTIK Survey

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective cases-report

Study drug and medical condition

• Name of medicine, other:
  Suplasyn
• Medical condition to be studied:
  Osteoarthritis

Population studied

• Short description of the study population:
  Patients over 18 years old with Primary Knee Osteoarthritis (Kellgren’s grades I to III) without effusion.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Knee Osteoarthritis patients
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  In this case, it is appropriate to evaluate, under real-life conditions, the short-term and long-term effectiveness of triple Suplasyn® 2ml intra-articular injections and to how the extended treatment regime may impact patient satisfaction or treatment safety.
• Outcomes:
  To assess changes in clinical outcome of patients with OA recommended with a triple Suplasyn® 2ml injection for viscosupplementation. - To evaluate the safety profile and adverse events (AEs) of Suplasyn® 2ml injections.- To evaluate the concomitant consumption of permitted rescue medications (analgesics, NSAIDS) throughout the study.- To evaluate characteristics of the beneficiary population (Intended to treat).
• Data analysis plan:
  The primary efficacy endpoint is the change from baseline in the Oxford knee score assessing the function of the OA knee at 4 and 26 weeks and the change from baseline in the patient-rated knee OA pain assessment (100 mm visual analogue scale/VAS) at 4 and 26 weeks.Both scores obtained with the Oxford Knee Score and Pain VAS will be registered at 1 and 6 months following viscosupplementation of the knee.Continuous variables will be expressed as mean ± Standard Deviation (SD) while categorical binary variables will be presented as percentages. Both primary and secondary objectives will be analyzed with tests for repeated measures to determinate the evolution of the variables throughout study visits. P values <0.05 will be considered as statistically significant.