Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee

Random, Phase IV, Multicentre, Double Blind, Placebo Controlled, Parallel Study to Assess Long-term Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid (ADANT®) in Patients With Knee OA of the Knee

The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.

To evaluate the efficacy and safety of repeated injections of hyaluronic acid compared with placebo over a period of 40 months.

Inclusion Criteria:

• Patient > 45 years of age
• Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
• Joint Space Width (JSW) > 2mm
• Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation

Exclusion Criteria:

• Overweight patients (body mass index > 32).
• Pregnant and lactating women. Women of child-bearinge age not using effective contraception
• Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
• AINE administration within the 14 days prior to their inclusion in the study.
• Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
• Immunocompromised patients or patients receiving systemic immunosuppressive therapy.
• Patients with known sensitivity to HA, parcetamol or AINEs permitted as rescue medication.
• Patients who have received any investigational drug within 30 days prior to visit 1, or who are scheduled for the administration of an investigational drug other than the protocol product during this study.
• Patients with severely impaired central nervous system.
• Patients with coagulation alterations, despite receiving treatment.
• Patients with secondary osteoarthritis of the knee
• Patients having previously received surgery, including arthroscopy
• Patients with articular inflammatory disease