Efficacy and Safety of 3 Different Dosage Regimens of Hyaluronic Acid in Patients With Knee Osteoarthritis (OA)

Pilot, Unicentre, Randomized, Parallel, Controlled Study to Evaluate the Efficacy and Safety of Three Different Intraarticular Dosage Regimens of Adant® in Patients With Osteoarthritis of the Knee

The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.

Inclusion Criteria:

• Outpatient>45 years of age diagnosed with primary osteoarthritis according to ACR and Kellgren criteria
• Knee pain ≥ 55 mm and ≤90 mm measured by Visual Analogue Scale (VAS) 100 mm
• Ability to understand and follow study procedures
• Written informed consent

Exclusion Criteria:

• Patients with secondary osteoarthritis of the knee according to ACR criteria.
• Severe inflammation of the knee diagnosed by physical examination or a sedimentation speed rate < 40 mm/h and serum rheumatoid factor titre < 1:40
• Patients having previously received surgery, including arthroscopy
• Patients with joint inflammatory disease (spondilitis, systemic rheumatoid arthritis), microcrystalline arthropathies (chondrocalcinosis, gout, fibromyalgia) and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment
• Previous administration of any of the following treatments: hyaluronic acid ia (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study