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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01243814
First Posted: November 19, 2010
Last Update Posted: March 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Henry DeGroot, M.D.
  Purpose
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.

Condition Intervention
Osteoarthritis Device: hyaluronate intra-articular injection Device: placebo injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Henry DeGroot, M.D.:

Primary Outcome Measures:
  • AOFAS score, difference from mean at 6 weeks and 12 weeks [ Time Frame: 6 weeks 12 weeks ]
    American Orthopaedic Foot and Ankle score


Enrollment: 69
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: supartz
active intervention arm
Device: hyaluronate intra-articular injection
joint injection in ankle with hyaluronate
Other Name: Supartz
Placebo Comparator: saline injection
placebo intervention arm
Device: placebo injection
joint injection with saline solution for placebo
Other Name: saline injection

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243814


Locations
United States, Massachusetts
The office of Dr. Henry DeGroot
Newton, Massachusetts, United States, 02462
Sponsors and Collaborators
Henry DeGroot, M.D.
Investigators
Principal Investigator: Henry DeGroot, MD Newton-Wellesley Hospital
  More Information

Responsible Party: Henry DeGroot, M.D., Henry DeGroot
ClinicalTrials.gov Identifier: NCT01243814     History of Changes
Other Study ID Numbers: N08-429
First Submitted: November 18, 2010
First Posted: November 19, 2010
Last Update Posted: March 20, 2012
Last Verified: November 2010

Keywords provided by Henry DeGroot, M.D.:
hyaluronate
hyaluronic acid
viscosupplementation

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents