Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis
NCT ID: NCT00642382
Last Updated: 2017-08-17
Study Results
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View full resultsBasic Information
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TERMINATED
NA
17 participants
INTERVENTIONAL
2008-04-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active
Agilus (Hyaluronic Acid)
Agilus
Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.
Control
Normal Saline
Normal saline
Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.
Interventions
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Agilus
Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.
Normal saline
Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
95 Years
ALL
No
Sponsors
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Cartiva, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Judith Baumhauer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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Orthopaedic Associates of Hartford
Farmington, Connecticut, United States
Pinnacle Research
Royal Palm Beach, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Institute For Foot and Ankle Reconstruction At Mercy
Baltimore, Maryland, United States
Greater Chesapeake Orthopaedic Association
Baltimore, Maryland, United States
Brigham Foot and Ankle Center
Boston, Massachusetts, United States
Orthopedic Associates of Grand Rapids
Grand Rapids, Michigan, United States
Minnesota Sports Medicine
Eden Prairie, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Desert Orthopaedic Center
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
UMDNJ
Newark, New Jersey, United States
University of Rochester
Rochester, New York, United States
Orthocarolina
Charlotte, North Carolina, United States
Orthopedic Foot and Ankle Center
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Bone and Joint Clinic Houston
Houston, Texas, United States
University of Texas Health Science Center At Houston
Houston, Texas, United States
Countries
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Other Identifiers
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CMI-CP-Ankle-001
Identifier Type: -
Identifier Source: org_study_id
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