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

Henry DeGroot, M.D.

Status

Completed

Conditions

Osteoarthritis

Treatments

Device: placebo injection

Device: hyaluronate intra-articular injection

Study type

Interventional

Funder types

Other

Identifiers

NCT01243814

N08-429

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.