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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Carticept Medical, Inc
ClinicalTrials.gov Identifier:
NCT00642382
First received: March 19, 2008
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
OSTEOARTHRITIS
Device: Agilus
Device: Normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Carticept Medical, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Other Name: Normal Saline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642382

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

No publications provided

Responsible Party: Carticept Medical, Inc
ClinicalTrials.gov Identifier: NCT00642382     History of Changes
Other Study ID Numbers: CMI-CP-Ankle-001
Study First Received: March 19, 2008
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Carticept Medical, Inc:
Osteoarthritis
Hyaluronic Acid

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014