Durolane Versus Methylprednisolone in Knee Osteoarthritis

Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee

The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.

Inclusion Criteria:

• Subject (female or male) 35-80 years of age
• Unilateral knee pain
• Radiographic evidence of OA
• WOMAC pain score of 7-17
• Subject normally active
• Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies);
• Subject cooperative and able to communicate effectively with the investigators;
• Body mass index ≤ 40 kg/m2;
• Signed informed consent obtained.

Exclusion Criteria:

• Knee effusion
• Contralateral knee OA
• Clinically significant joint pain from joints other than the knee
• Previous intra-articular steroid injection into the study knee within the last 3 months;
• Previous intra-articular HA injection into the study knee within the last 9 months;
• Previous allergic type reaction to a HA product, a steroid, or lidocaine/related anesthetics;
• Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit;
• Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months;
• Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
• Change in physical therapy for the knee within the last three months
• Arthroscopy or other surgical procedure in the study knee within the past 12 months;
• Any planned arthroscopy or other surgical procedure during the study period;
• Previous history or presence of active septic arthritis
• Active skin disease or infection in the area of the injection site;
• Systemic active inflammatory condition or infection
• Bleeding diathesis or use of anticoagulants
• Current uncontrolled diabetes mellitus;
• Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
• Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception;
• Involvement in other clinical trials