Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis - Full Text View

Sponsor:	Carticept Medical, Inc
Information provided by:	Carticept Medical, Inc
ClinicalTrials.gov Identifier:	NCT00642382

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Hyaluronic acid Hyaluronate Sodium

U.S. FDA Resources

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: Active Comparator 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.
Control: Placebo Comparator 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.

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

Show 19 Study Locations

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 ( Katie Wedbush )
Study ID Numbers:	CMI-CP-Ankle-001
Study First Received:	March 19, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00642382 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Carticept Medical, Inc:

Osteoarthritis
Hyaluronic Acid

Additional relevant MeSH terms:

Immunologic Factors
Musculoskeletal Diseases
Hyaluronic Acid
Osteoarthritis
Joint Diseases

Arthritis
Physiological Effects of Drugs
Adjuvants, Immunologic
Rheumatic Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009