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

Not Applicable

Terminated

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Active	Agilus	Agilus (Hyaluronic Acid)
Control	Normal saline	Normal Saline

Primary Outcome Measures

Name	Time	Method
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.	At 4, 12 and 26 weeks post 3rd injection

Secondary Outcome Measures

Name	Time	Method
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.	At 4, 12 and 26 weeks post 3rd injection

Locations (19): Orthopedic Associates of Grand Rapids
🇺🇸
Grand Rapids, Michigan, United States
Minnesota Sports Medicine
🇺🇸
Eden Prairie, Minnesota, United States
Dartmouth Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Pinnacle Research
🇺🇸
Royal Palm Beach, Florida, United States
Orthopaedic Associates of Hartford
🇺🇸
Farmington, Connecticut, United States
Brigham Foot and Ankle Center
🇺🇸
Boston, Massachusetts, United States
Orthocarolina
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Charlotte, North Carolina, United States
Rush University Medical Center
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Chicago, Illinois, United States
Greater Chesapeake Orthopaedic Association
🇺🇸
Baltimore, Maryland, United States
Institute For Foot and Ankle Reconstruction At Mercy
🇺🇸
Baltimore, Maryland, United States
University of Missouri
🇺🇸
Columbia, Missouri, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
UMDNJ
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Newark, New Jersey, United States
Orthopedic Foot and Ankle Center
🇺🇸
Columbus, Ohio, United States
Desert Orthopaedic Center
🇺🇸
Las Vegas, Nevada, United States
Bone and Joint Clinic Houston
🇺🇸
Houston, Texas, United States
University of Texas Health Science Center At Houston
🇺🇸
Houston, Texas, United States
University of Rochester
🇺🇸
Rochester, New York, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States