• The comparison between the Agilus injection and the saline control injection groups in the proportion of subjects experiencing a reduction in the assessment of pain determined by the AOS subscale for pain. [ Time Frame: At 4, 12 and 26 weeks post 3rd injection ] [ Designated as safety issue: No ]
  

• Secondary effectiveness parameters that will be evaluated include the following that evaluate pain, function, subject's global assessment, quality of life and an individual subject responder analysis. [ Time Frame: At 4, 12 and 26 weeks post 3rd injection ] [ Designated as safety issue: No ]
  

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