Clinical trial NCT00642382: Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: OSTEOARTHRITIS
Keywords: Osteoarthritis
Hyaluronic Acid
Lead sponsor: Cartiva, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: At 4, 12 and 26 weeks post 3rd injection
Secondary outcomes:
measure: 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.
timeFrame: At 4, 12 and 26 weeks post 3rd injection
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Orthopaedic Associates of Hartford
state: Connecticut
city: Royal Palm Beach
country: United States
facility: Pinnacle Research
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Institute For Foot and Ankle Reconstruction At Mercy
state: Maryland
city: Baltimore
country: United States
facility: Greater Chesapeake Orthopaedic Association
state: Maryland
city: Boston
country: United States
facility: Brigham Foot and Ankle Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Orthopedic Associates of Grand Rapids
state: Michigan
city: Eden Prairie
country: United States
facility: Minnesota Sports Medicine
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Las Vegas
country: United States
facility: Desert Orthopaedic Center
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Newark
country: United States
facility: UMDNJ
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Orthocarolina
state: North Carolina
city: Columbus
country: United States
facility: Orthopedic Foot and Ankle Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: Bone and Joint Clinic Houston
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center At Houston
state: Texas
Study officials:
affiliation: University of Rochester
name: Judith Baumhauer, MD
role: PRINCIPAL_INVESTIGATOR
References: