The Effectiveness and Safety of Single 6ml Hyaluronic Acid Intra-articular Injection (Suplasyn® 1-shot) in Managing Symptomatic Primary Osteoarthritis of the Knee in Real-life Practice: ESSIK 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 1-shot
• 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:
  Adults (18 to < 46 years)

  Adults (46 to < 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:
  The intention is to assess the efficacy and safety of the treatment in real-life practice. Our primary target is to obtain and verify long-term outcomes from a naturalistic primary care experience.
• Outcomes:
  To assess changes in clinical outcome of patients with OA recommended with a single injection with Suplasyn® 1-shot viscosupplementation for knee OA during a 26 weeks follow-up. - To evaluate the safety profile and adverse events (AEs) of Suplasyn® 1-shot injection.- 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 and the change from baseline in the patient-rated knee OA pain assessment 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.Secondary objectives correspond to the evaluation of the safety profile and adverse events (AEs) of Suplasyn® 1-shot 6ml injection, assessment of concomitant consumption of permitted rescue medications (analgesics, NSAIDs) throughout the study and the known the characteristics of the beneficiary population (intend-to-treat).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.