Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

A Multi Center, Randomized, Double Blind, Saline Controlled Study of a Single Injection of Durolane® Versus a Single Injection of Phosphate Buffered Saline (PBS) to Treat Pain Associated With Osteoarthritis of the Knee

The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee.

Inclusion Criteria:

• Body Mass Index (BMI) ≤ 35 kg/m2
• Symptomatic osteoarthritis (OA) of the knee
• K L severity grade 1 or 2
• If bilateral OA, contralateral knee K L severity grade 0 or 1

Exclusion Criteria:

• Has clinically apparent tense effusion of the index knee
• Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
• Has any painful orthopedic disorders of the back or hip
• Has a joint disorder other than osteoarthritis in the index knee