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Hydros Joint Therapy and Hydros TA Joint Therapy for Pain Associated With Knee Osteoarthritis (OA)

2014-08-27 03:13:16 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and performance of Hydros Joint Therapy (Hydros) and Hydros TA Joint Therapy (Hydros TA) for treatment of pain from osteoarthritis of the knee, in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

Description

The objective of the study is to evaluate Hydros and Hydros TA treated subject for reduction of osteoarthritis symptoms, compared to a commercial control, as assessed by the WOMAC Osteoarthritis Index.

The WOMAC Osteoarthritis Index is a validated assessment instrument that is self-administered and designed to subjectively elicit patient symptoms of osteoarthritis in the knee in the areas of pain, stiffness, and physical function. The WOMAC Osteoarthritis Index with its Pain Subscale has been used extensively as an effectiveness endpoint in clinical trials of viscosupplements.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Osteoarthritis of the Knee

Intervention

Hydros Joint Therapy, Hydros TA Joint Therapy, Synvisc-One

Location

London Health Sciences Centre Research
London
Ontario
Canada
N6A 4G5

Status

Recruiting

Source

Carbylan BioSurgery, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:16-0400

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