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

• Sponsor: Henry DeGroot, M.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01243814
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Device: hyaluronate intra-articular injection; Device: placebo injection	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: supartz active intervention arm	Device: hyaluronate intra-articular injection; joint injection in ankle with hyaluronate; Other Names: Supartz
Placebo Comparator: saline injection placebo intervention arm	Device: placebo injection; joint injection with saline solution for placebo; Other Names: saline injection

Outcome Measures

Primary Outcome Measures

1. AOFAS score, difference from mean at 6 weeks and 12 weeks [6 weeks 12 weeks]

   American Orthopaedic Foot and Ankle score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The office of Dr. Henry DeGroot	Newton	Massachusetts	United States	02462

Sponsors and Collaborators

• Henry DeGroot, M.D.

Investigators

• Principal Investigator: Henry DeGroot, MD, Newton-Wellesley Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01243814
• Other Study ID Numbers: N08-429
• First Posted: Nov 19, 2010
• Last Update Posted: Mar 20, 2012
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: hyaluronate; hyaluronic acid; viscosupplementation
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Mar 20, 2012