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

Primary Purpose

OSTEOARTHRITIS

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Agilus
Normal saline
Sponsored by
Cartiva, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OSTEOARTHRITIS focused on measuring Osteoarthritis, Hyaluronic Acid

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopaedic Associates of Hartford
  • Pinnacle Research
  • Rush University Medical Center
  • Institute For Foot and Ankle Reconstruction At Mercy
  • Greater Chesapeake Orthopaedic Association
  • Brigham Foot and Ankle Center
  • Orthopedic Associates of Grand Rapids
  • Minnesota Sports Medicine
  • University of Missouri
  • Desert Orthopaedic Center
  • Dartmouth Hitchcock Medical Center
  • UMDNJ
  • University of Rochester
  • Orthocarolina
  • Orthopedic Foot and Ankle Center
  • University of Pennsylvania
  • Rhode Island Hospital
  • Bone and Joint Clinic Houston
  • University of Texas Health Science Center At Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Control

Arm Description

Agilus (Hyaluronic Acid)

Normal Saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 19, 2008
Last Updated
July 18, 2017
Sponsor
Cartiva, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00642382
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
For safety concerns
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cartiva, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSTEOARTHRITIS
Keywords
Osteoarthritis, Hyaluronic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
Agilus (Hyaluronic Acid)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Normal Saline
Intervention Type
Device
Intervention Name(s)
Agilus
Other Intervention Name(s)
Hyaluronic Acid
Intervention Description
Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.
Intervention Type
Device
Intervention Name(s)
Normal saline
Intervention Description
Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Baumhauer, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Associates of Hartford
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Pinnacle Research
City
Royal Palm Beach
State/Province
Florida
ZIP/Postal Code
33411
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Institute For Foot and Ankle Reconstruction At Mercy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Greater Chesapeake Orthopaedic Association
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Brigham Foot and Ankle Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Orthopedic Associates of Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Minnesota Sports Medicine
City
Eden Prairie
State/Province
Minnesota
ZIP/Postal Code
55344
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Desert Orthopaedic Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
UMDNJ
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Orthocarolina
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Orthopedic Foot and Ankle Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Bone and Joint Clinic Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center At Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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