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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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OSTEOARTHRITIS

Intervention / Treatment
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* Device: Agilus
* Device: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Agilus (Hyaluronic Acid) | Device: Agilus<br>* Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.<br>* Other names: Hyaluronic Acid;|
| Placebo Comparator: Control<br>Normal Saline | Device: Normal saline<br>* Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Hyaluronic Acid