Clinical trial: Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis (NCT01806207)

Eligibility criteria:
Inclusion Criteria:

          -  Osteoarthritis according to ACR (American College of Radiology) criteria for the knee

          -  WOMAC pain score in the range 7 to 17

          -  Significant knee pain for the majority of days during the past 3 months

          -  Patient normally active, not bedridden or confined to a wheelchair and able to walk 50
             meters without the help of a walker, crutches or a cane

          -  Patient has attempted but not responded adequately to non-pharmacological therapy(ies)

          -  Patient co-operative and able to communicate effectively with the investigators

          -  Signed informed consent obtained

        Exclusion Criteria:

          -  Bilateral knee osteoarthritis

          -  Osteoarthritis or clinically significant pain from other part of the musculoskeletal
             system than the study knee

          -  Kellgren Lawrence radiographic score grade IV for the study knee

          -  Change in physical therapy/occupational therapy for the knee within the last 3 months

          -  Treatment with nonsteroidal antiinflammatory drugs (NSAIDs) (including topical agents
             for the study knee) during the last week (or 5 half-lives of the drug, whichever is
             longer) prior to baseline visit

          -  Treatment with non-NSAID topicals such as capsaicin for the knee within the last 3
             days

          -  Intra-articular injection with corticosteroids in the study knee within the last 3
             months

          -  Use of systemic steroids (excluding inhalation steroids) within the last 3 months

          -  Intra-articular injections with hyaluronic acid in the study knee within the last 9
             months

          -  Treatment with glucosamine/chondroitin sulfate within the last 3 months

          -  Treatment with pain relievers except for paracetamol up to 4g/day

          -  Treatment with anticoagulant (except for acetylsalicylic acid max. 325 mg/day)

          -  Arthroscopy or any other surgical procedure in the study knee within the last 12
             months

          -  Planned arthroscopy or any other surgical procedure during the study period

          -  Any medical condition which in the opinion of the investigator makes the patient
             unsuitable for inclusion (e.g. severe progressive chronic disease, malignancy,
             bleeding disorder, fibromyalgia)

          -  Systemic active inflammatory condition or infection, such as Rheumatoid arthritis,
             inflammatory arthritis, ankylosing spondylitis, psoriatic arthritis, reactive
             arthritis, gout/acute pseudogout or any other connective tissue disease

          -  Septic arthritis in the study knee within the last 3 months

          -  Active skin disease or infection in the area of the injection site

          -  Significant venous or lymphatic stasis present in the legs

          -  Pregnant or breast-feeding woman or woman of child-bearing potential not practicing
             adequate contraception

          -  Subjects that in the opinion of the investigator are unsuitable for inclusion (e.g.
             subjects not likely to avoid other therapies, subjects not likely to stay in the study
             during the whole study period, or subjects likely to be unreliable)

          -  Concurrent participation in any other clinical study or participation within the
             preceding 30 days
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 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? Contradiction