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

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ClinicalTrials.gov Identifier: NCT00642382
Recruitment Status : Terminated (For safety concerns)
First Posted : March 25, 2008
Results First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Cartiva, Inc.

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

Condition or disease Intervention/treatment Phase
OSTEOARTHRITIS Device: Agilus Device: Normal saline Not Applicable

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  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : April 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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 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.



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642382


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

Responsible Party: Cartiva, Inc.
ClinicalTrials.gov Identifier: NCT00642382     History of Changes
Other Study ID Numbers: CMI-CP-Ankle-001
First Posted: March 25, 2008    Key Record Dates
Results First Posted: August 17, 2017
Last Update Posted: August 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cartiva, 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
Viscosupplements
Protective Agents