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

This study has been terminated.
(For safety concerns)
Information provided by (Responsible Party):
Cartiva, Inc. Identifier:
First received: March 19, 2008
Last updated: November 15, 2016
Last verified: November 2016
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
Device: Agilus
Device: Normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 Cartiva, 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 ]

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 ]

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.

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.

Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00642382

  Show 19 Study Locations
Sponsors and Collaborators
Cartiva, Inc.
Principal Investigator: Judith Baumhauer, MD University of Rochester
  More Information

Responsible Party: Cartiva, Inc. Identifier: NCT00642382     History of Changes
Other Study ID Numbers: CMI-CP-Ankle-001
Study First Received: March 19, 2008
Last Updated: November 15, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Cartiva, Inc.:
Hyaluronic Acid

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on May 22, 2017