Clinical trial: Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee (NCT00669032)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? 1