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

Launched by ANIKA THERAPEUTICS, INC. · Apr 2, 2008

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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