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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: hyaluronate intra-articular injection
* Device: placebo injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: supartz<br>active intervention arm | Device: hyaluronate intra-articular injection<br>* joint injection in ankle with hyaluronate<br>* Other names: Supartz;|
| Placebo Comparator: saline injection<br>placebo intervention arm | Device: placebo injection<br>* joint injection with saline solution for placebo<br>* Other names: saline injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOFAS score, difference from mean at 6 weeks and 12 weeks | American Orthopaedic Foot and Ankle score | 6 weeks 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyaluronate, hyaluronic acid, viscosupplementation