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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Device: hyaluronate intra-articular injection; Device: placebo injection

• Registration Number: NCT01243814
• Lead Sponsor: Henry DeGroot, M.D.

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-11
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supartz	hyaluronate intra-articular injection	active intervention arm
saline injection	placebo injection	placebo intervention arm

Primary Outcome Measures

Name	Time	Method
AOFAS score, difference from mean at 6 weeks and 12 weeks	6 weeks 12 weeks	American Orthopaedic Foot and Ankle score

Trial Locations

Locations (1)

The office of Dr. Henry DeGroot; 🇺🇸 Newton, Massachusetts, United States