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

NCT01243814 | Completed

• 1 other identifier: N08-429
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

hyaluronate; hyaluronic acid; viscosupplementation

Outcome Measures

Primary Outcomes (1)

• AOFAS score, difference from mean at 6 weeks and 12 weeks

  American Orthopaedic Foot and Ankle score

  6 weeks 12 weeks

Study Arms (2)

supartz

ACTIVE COMPARATOR

active intervention arm

Device: hyaluronate intra-articular injection

saline injection

PLACEBO COMPARATOR

placebo intervention arm

Device: placebo injection

Interventions

hyaluronate intra-articular injection DEVICE

joint injection in ankle with hyaluronate

Also known as: Supartz

supartz

placebo injection DEVICE

joint injection with saline solution for placebo

Also known as: saline injection

saline injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry DeGroot, M.D.: lead

Study Sites (1)

The office of Dr. Henry DeGroot

Newton, Massachusetts, 02462, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Henry DeGroot, MD

  Newton-Wellesley Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 20, 2012

Record last verified: 2010-11

Locations

US (1)