Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis
This study has been terminated.
Sponsor:
Carticept Medical, Inc
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
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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
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Hide Study LocationsLocations
| 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 May 23, 2013