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

NCT ID: NCT01243814

Last Updated: 2012-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-09-30

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

supartz

active intervention arm

Group Type: ACTIVE_COMPARATOR

hyaluronate intra-articular injection

Intervention Type: DEVICE

joint injection in ankle with hyaluronate

saline injection

placebo intervention arm

Group Type: PLACEBO_COMPARATOR

placebo injection

Intervention Type: DEVICE

joint injection with saline solution for placebo

Interventions

hyaluronate intra-articular injection

joint injection in ankle with hyaluronate

Intervention Type: DEVICE

placebo injection

joint injection with saline solution for placebo

Intervention Type: DEVICE

Other Intervention Names

Supartz; saline injection

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry DeGroot, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Henry DeGroot

Principal Investigators

Henry DeGroot, MD

Role: PRINCIPAL_INVESTIGATOR

Newton-Wellesley Hospital

Locations

The office of Dr. Henry DeGroot

Newton, Massachusetts, United States

Countries

United States

Other Identifiers

N08-429

Identifier Type: -

Identifier Source: org_study_id