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

Cartiva, Inc.17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

OSTEOARTHRITIS

Interventions

AgilusDEVICE

Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.

Normal salineDEVICE

Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (19)

Orthopaedic Associates of Hartford

Farmington, Connecticut, United States

Pinnacle Research

Royal Palm Beach, Florida, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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