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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/28698
• EU PAS number:
  EUPAS11712
• Study ID:
  28698
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Armenia

  Croatia

  Czechia

  Kazakhstan

  Saudi Arabia

  Slovenia

  Uzbekistan
• Study description:
  The current study is designed to assess the effectiveness and safety of Suplasyn® 2ml injections in a 26-week, international, multicenter, non-interventional observational study of patients recommended with one 2 ml intra-articular injection of Suplasyn® per week for three consecutive weeks with for the treatment of knee osteoarthritis. 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. Rationale for using viscosupplementation is to restore the protective viscoelasticity of synovial hyaluronic acid, decrease pain and improve mobility. Immediate benefit of viscosupplementation is the relief of pain while long-term benefits results are believed to include the return of joint mobility by the restoration of trans-synovial flow and the metabolic and rheological homeostasis of the joint. Short duration of HA within the joint does not fully explain the indisputable long-term clinical efficacy seen in practice.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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Krnov Hospital

Multiple centres: 24 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 16/06/2014

Study start date

Actual: 08/07/2014

Date of interim report, if expected

Planned: 12/12/2016

Date of final study report

Planned: 12/12/2016

Actual: 27/02/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Mylan Institutional International

Study protocol

Initial protocol

ESTIK Protocol_Adapted_130614

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable