NCT01243814

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Henry DeGroot, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	hyaluronate intra-articular injection	joint injection in ankle with hyaluronate
DEVICE	placebo injection	joint injection with saline solution for placebo

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-11-19
• Last updated: 2012-03-20

Locations

1 site across 1 country: United States