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

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

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.

Inclusion Criteria:

• 18 years or older
• Chronic, unilateral ankle pain(i.e., in only one ankle) for at least 6 months
• Diagnosis of ankle OA confirmed by radiographs (X-ray)and clinical exam
• Are normally active, without aid of mobility devices(such as crutch, walker or cane)

Exclusion Criteria:

• Have used oral steroids within 30 days (inhaled or topical steroids are acceptable)
• Have received intra-articular injections of hyaluronic acid in any joint in the last 9 months
• Have received steroid injections in any joint in last 3 months
• Have had previous surgery or arthroscopy on the affected ankle in the last 12 months