A Double-blind RCT of a Single Dose of Hyaluronan in the Treatment of Osteoarthritis of the Ankle

March 19, 2012 updated by: Henry DeGroot, M.D.

A Double-blind, Randomized, Placebo-controlled Study of the Relative Efficacy of a Single Dose of Hyaluronan in the Treatment of Osteoarthritis of the Ankle

To compare the therapeutic effect of single intra-articular injection of hyaluronate with a single intra-articular injection of normal saline (placebo) for osteoarthritis of the ankle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, prospective, double-blind (blinded observer) , saline solution-controlled, parallel experimental design. The study device is SUPARTZ (Seikagaku Corporation, Tokyo, Japan) a brand of sodium hyaluronate.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • The office of Dr. Henry DeGroot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To be eligible, subjects had to be at least 18 years old, not pregnant, and have pain and osteoarthritis of the ankle of at least stage 2 on the Kellgren and Lawrence scale.
  • Their AOFAS score had to be 90 points or less out of a possible 100 points.
  • Eligible subjects had to be willing to discontinue all pain medications and NSAIDs other than the rescue pain medications provided in the study.

Exclusion Criteria:

  • Persons with systemic inflammatory condition or infection of the ankle or nearby soft tissues,
  • an injection of steroid or surgery on the involved joint within 6 months,
  • local cellulitis, rash, skin condition
  • diabetic or neuropathic Charcot arthropathy,
  • significant vascular insufficiency,
  • current treatment with anticoagulants,
  • lower extremity pain syndromes, sciatica, sprains, plantar fasciitis,
  • significant ankle instability or malalignment,
  • any known allergy to any of the components of either injection, known or suspected allergy to birds or bird products,
  • disabling degenerative joint disease of the ipsilateral hip, knee or foot were ineligible for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: supartz
active intervention arm
Device: hyaluronate intra-articular injection
joint injection in ankle with hyaluronate
Other Names:
  • Supartz
Placebo Comparator: saline injection
placebo intervention arm
Device: placebo injection
joint injection with saline solution for placebo
Other Names:
  • saline injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AOFAS score, difference from mean at 6 weeks and 12 weeks
Time Frame: 6 weeks 12 weeks
American Orthopaedic Foot and Ankle score
6 weeks 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry DeGroot, M.D.

Investigators

  • Principal Investigator: Henry DeGroot, MD, Newton-Wellesley Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N08-429

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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