Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis

OSTEOARTHRITIS Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00642382
• Other study ID #: CMI-CP-Ankle-001
• Status: Terminated
• Phase: Phase 3
• First received: March 19, 2008
• Last updated: November 15, 2016
• Start date: April 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2016
• Source: Cartiva, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• OSTEOARTHRITIS

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Greater Chesapeake Orthopaedic Association	Baltimore	Maryland
United States	Institute For Foot and Ankle Reconstruction At Mercy	Baltimore	Maryland
United States	Brigham Foot and Ankle Center	Boston	Massachusetts
United States	Orthocarolina	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Missouri	Columbia	Missouri
United States	Orthopedic Foot and Ankle Center	Columbus	Ohio
United States	Minnesota Sports Medicine	Eden Prairie	Minnesota
United States	Orthopaedic Associates of Hartford	Farmington	Connecticut
United States	Orthopedic Associates of Grand Rapids	Grand Rapids	Michigan
United States	Bone and Joint Clinic Houston	Houston	Texas
United States	University of Texas Health Science Center At Houston	Houston	Texas
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 Pennsylvania	Philadelphia	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of Rochester	Rochester	New York
United States	Pinnacle Research	Royal Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cartiva, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No