Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee

A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate to Provide Symptomatic Relief of Osteoarthritis of the Knee

The purpose of this study is to determine whether intra-articular injection of Monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

This randomized, double-blind, placebo controlled prospective study will assess the safety and effectiveness of a single intra-articular injection of Monovisc® in providing symptomatic relief of pain caused by idiopathic osteoarthritis (OA) of the knee as compared to a placebo comparator injection of sterile saline.

Main Inclusion Criteria:

• Male or Female
• Age 35 to 75 years
• Body Mass Index (BMI) 20 to 40 kg/m2
• Willing and able to provide informed consent
• Willing to limit analgesic use to acetaminophen 7 days prior to and 12 weeks after injection
• Not pregnant or lactating
• Previous conservative treatment regimen for osteoarthritis (OA)
• Diagnosis of idiopathic OA of the index knee
• OA symptoms for >= 6 months
• Index knee Kellgren-Lawrence (K-L) grade of II or III
• Index knee Baseline Summed WOMAC Pain Score >= 200mm and < 400mm after NSAID washout
• Contralateral Knee K-L grade 0, I or II
• Contralateral Knee Baseline WOMAC Pain Score < 150mm after NSAID washout

Main Exclusion Criteria:

• Joint disorders which could interfere with treatment effectiveness
• Joint disorders which could interfere with study assessments
• Arthroscopy of either knee within 3 months of screening
• Open surgery of index knee within 12 months of screening
• Open surgery of contralateral knee within 3 months of screening
• Injection of Hyaluronic Acid (HA) in either knee within 6 months of screening
• Injection of steroid in index knee within 3 months of screening
• Any pre-treatment contraindication for injection or aspiration of the index knee, including cutaneous infection, intra-articular infection, knee deformity or condition which may jeopardize sterility or delivery of injection
• Synovial fluid aspirate volume > 20 milliliters (mL)
• Visual appearance of synovial fluid that contraindicates injection
• Index knee range of motion < 90 degrees
• Subject participation in other research study within 30 days of screening
• Subject unwilling to maintain active lifestyle, exercise program and body weight similar to that during 3 months prior to screening for duration of study
• Unwilling to maintain constant dosage of oral glucosamine or chondroitin sulfate for duration of study, if applicable
• Other medication or treatments that could interfere with study injection or assessments
• Allergy to gram positive bacterial products or intolerance of acetaminophen
• Active fibromyalgia
• Peripheral neuropathy severe enough to interfere with evaluation of either knee
• Vascular insufficiency severe enough to interfere with evaluation of the subject
• Hemiparesis involving either lower extremity
• Systemic bleeding disorder
• Other conditions which may adversely affect the success of the procedure