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

Cartiva

Status

Terminated

Conditions

OSTEOARTHRITIS

Treatments

Device: Agilus

Device: Normal saline

Study type

Interventional

Funder types

Industry

Identifiers

NCT00642382

CMI-CP-Ankle-001

Details and patient eligibility

About

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

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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