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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01243814

Enrollment

Registered

2010-11-19

Start date

2009-10-31

Completion date

2010-09-30

Last updated

2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

hyaluronate, hyaluronic acid, viscosupplementation

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.

Interventions

DEVICEhyaluronate intra-articular injection

joint injection in ankle with hyaluronate

DEVICEplacebo injection

joint injection with saline solution for placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
AOFAS score, difference from mean at 6 weeks and 12 weeks	6 weeks 12 weeks	American Orthopaedic Foot and Ankle score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026