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

NCT00642382 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-08-17

Study results available
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Summary

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

Conditions

Interventions

DEVICE

Agilus

Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.

DEVICE

Normal saline

Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.

Sponsors & Collaborators

  • Cartiva, Inc.

    lead INDUSTRY

Principal Investigators

  • Judith Baumhauer, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-10-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00642382 on ClinicalTrials.gov