Status:
COMPLETED
A Double-blind RCT of a Single Dose of Hyaluronan in the Treatment of Osteoarthritis of the Ankle
Lead Sponsor:
Henry DeGroot, M.D.
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01243814
Start Date
October 1 2009
End Date
September 1 2010
Last Update
March 20 2012
Active Locations (1)
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1
The office of Dr. Henry DeGroot
Newton, Massachusetts, United States, 02462