NCT00642382

Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis

Randomized, Double Blind,Saline-Controlled, Multi-Center, Prospective Study to Evaluate the Safety and Effectiveness of Carticept's Agilus Device for the Treatment of Ankle Osteoarthritis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Cartiva, Inc. · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.

Detailed description

The objective of this study is to compare the safety and effectiveness of Agilus to a saline injection (control) in the treatment of mild to moderate ankle osteoarthritis. This is a multi-center, randomized, double blind, saline controlled, prospective study with two (2) treatment groups. The active group will receive one injection of Agilus per week for three consecutive weeks for a total of three injections. The control group will receive one injection of normal saline per week for three consecutive weeks for a total of three injections. Follow up visits will occur at 4 weeks, 12 weeks and 26 weeks following the third injection.

Conditions

• OSTEOARTHRITIS

Interventions

Type	Name	Description
DEVICE	Agilus	Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.
DEVICE	Normal saline	Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-10-01
• Completion: 2008-12-01
• First posted: 2008-03-25
• Last updated: 2017-08-17
• Results posted: 2017-08-17

Locations

19 sites across 1 country: United States