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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:
Information provided by:
Henry DeGroot, M.D.
ClinicalTrials.gov Identifier:
NCT01243814
First received: November 18, 2010
Last updated: March 19, 2012
Last verified: November 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Henry DeGroot, M.D., Henry DeGroot
ClinicalTrials.gov Identifier: NCT01243814     History of Changes
Other Study ID Numbers: N08-429
Study First Received: November 18, 2010
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013