NCT00653432

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Anika Therapeutics, Inc. · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Monovisc®	Intra-articular injection
OTHER	Saline	0.9% Sterile Saline

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2008-04-07
• Last updated: 2023-07-11
• Results posted: 2020-09-01

Locations

31 sites across 2 countries: United States, Canada