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

July 18, 2017 updated by: Cartiva, Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Orthopaedic Associates of Hartford
    • Florida
      • Royal Palm Beach, Florida, United States, 33411
        • Pinnacle Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Institute for Foot and Ankle Reconstruction at Mercy
      • Baltimore, Maryland, United States, 21218
        • Greater Chesapeake Orthopaedic Association
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham Foot and Ankle Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Orthopedic Associates of Grand Rapids
    • Minnesota
      • Eden Prairie, Minnesota, United States, 55344
        • Minnesota Sports Medicine
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Desert Orthopaedic Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07101
        • UMDNJ
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • OrthoCarolina
    • Ohio
      • Columbus, Ohio, United States, 43231
        • Orthopedic Foot and Ankle Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77030
        • Bone and Joint Clinic Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: At 4, 12 and 26 weeks post 3rd injection
At 4, 12 and 26 weeks post 3rd injection

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: At 4, 12 and 26 weeks post 3rd injection
At 4, 12 and 26 weeks post 3rd injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cartiva, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Actual)

August 17, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMI-CP-Ankle-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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