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

Completed · Not applicable · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID: NCT01243814
Run by: Henry DeGroot, M.D.
People needed: 69
Starts: 2009-10-01
Expected to finish: 2010-09-01
Last updated by the study team: 2012-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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