Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis
The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.
|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|
- 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 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 ]
|Study Start Date:||April 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Active
Agilus (Hyaluronic Acid)
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
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642382
Show 19 Study Locations
|Principal Investigator:||Judith Baumhauer, MD||University of Rochester|