Status:
TERMINATED
Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis
Lead Sponsor:
Cartiva, Inc.
Conditions:
OSTEOARTHRITIS
Eligibility:
All Genders
18-95 years
Phase:
NA
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.
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, rand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00642382
Start Date
April 1 2008
End Date
December 1 2008
Last Update
August 17 2017
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Orthopaedic Associates of Hartford
Farmington, Connecticut, United States, 06032
2
Pinnacle Research
Royal Palm Beach, Florida, United States, 33411
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
4
Institute For Foot and Ankle Reconstruction At Mercy
Baltimore, Maryland, United States, 21202