Osteoarthritis, Knee Clinical Trial
Official title:
Prospective, Multicentre Study to Evaluate the Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients Suffering From Osteoarthritis of the Knee
A Phase III, prospective, multicentre, non-controlled, with consecutive participant
enrollment in order to evaluate the efficacy, safety and duration of the effects of the
viscosupplementation with a preparation of sodium hyaluronate 2% (SH2%) from Tedec-Meiji
Farma S.A. over 12 months. Adult patients diagnosed with primary osteoarthritis of the knee
according to American College of Rheumatology (ACR) criteria with radiological grades II and
III according to Kellgren-Lawrence scale (KL) will receive a single injection of SH2% and
will be followed for 1 year with follow up visits at 6 and 12 months.
At 6 months patients could be offered a second injection whenever and when they comply with
the criteria established for re-treatment and will be followed for additional 6 months
Prospective, multicentre and non-controlled study. Each patient will receive a single
injection of SH 2% and will be followed for 1 year with follow up visits at 6 and 12 months
At 6 months follow up visit patients will be offered a second injection whenever and when
they comply with the criteria established for re-treatment and will be followed for
additional 6 months From the pre-inclusion V0 up to the V1 (beginning of treatment), there
will be a wash-out period of 2 weeks during which only paracetamol will be allowed for
osteoarthritis (OA) pain relief (maximum dose allowed:3g/day).
Paracetamol will be discontinued at least 24h before follow up visits (Treatment
administration, 6 months of follow up and 12 months of follow up).
Clinical evaluation will be done every visits through VAS, WOMAC and Patient's Global
Assessment/ Investigator's Global Assessment (PGA/IGA)
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