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

Henry DeGroot, M.D.1 site in 1 country69 target enrollmentOctober 2009

ConditionsOsteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Henry DeGroot, M.D.
Enrollment: 69
Locations: 1
Primary Endpoint: AOFAS score, difference from mean at 6 weeks and 12 weeks
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 brand of sodium hyaluronate.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

September 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Henry DeGroot, M.D.

Eligibility 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.