Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis

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…