Study Stopped
For safety concerns
Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis
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
1 other identifier
interventional
17
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2008
Shorter than P25 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
August 17, 2017
CompletedAugust 17, 2017
July 1, 2017
6 months
March 19, 2008
January 30, 2017
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
At 4, 12 and 26 weeks post 3rd injection
Secondary Outcomes (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.
At 4, 12 and 26 weeks post 3rd injection
Study Arms (2)
Active
ACTIVE COMPARATORAgilus (Hyaluronic Acid)
Control
PLACEBO COMPARATORNormal Saline
Interventions
Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.
Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cartiva, Inc.lead
Study Sites (19)
Orthopaedic Associates of Hartford
Farmington, Connecticut, 06032, United States
Pinnacle Research
Royal Palm Beach, Florida, 33411, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Institute For Foot and Ankle Reconstruction At Mercy
Baltimore, Maryland, 21202, United States
Greater Chesapeake Orthopaedic Association
Baltimore, Maryland, 21218, United States
Brigham Foot and Ankle Center
Boston, Massachusetts, 02115, United States
Orthopedic Associates of Grand Rapids
Grand Rapids, Michigan, 49525, United States
Minnesota Sports Medicine
Eden Prairie, Minnesota, 55344, United States
University of Missouri
Columbia, Missouri, 65212, United States
Desert Orthopaedic Center
Las Vegas, Nevada, 89121, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
UMDNJ
Newark, New Jersey, 07101, United States
University of Rochester
Rochester, New York, 14642, United States
Orthocarolina
Charlotte, North Carolina, 28203, United States
Orthopedic Foot and Ankle Center
Columbus, Ohio, 43231, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19106, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Bone and Joint Clinic Houston
Houston, Texas, 77030, United States
University of Texas Health Science Center At Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Clinical Operations
- Organization
- Cartiva, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Judith Baumhauer, MD
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 25, 2008
Study Start
April 1, 2008
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
August 17, 2017
Results First Posted
August 17, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share