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

Carbylan Therapeutics, Inc.98 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Osteoarthritis of the Knee

Interventions

Hydros Joint TherapyDEVICE

Single intra-articular injection.

Hydros-TA Joint TherapyDEVICE

Single intra-articular injection

Synvisc-OneDEVICE

Single intra-articular injection.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Osteoarthritis grade 2 or 3 in one knee using Kellgren-Lawrence Grading for OA radiologically and verified within the prior 6 months. Exclusion Criteria: * Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease. * Generalized symptomatic OA in lower extremity joints other than the knees. * Active infection in either knee joint or adjacent tissues. * Any contraindications for intra-articular injection or aspiration. * Knee surgery or trauma within 3 months prior to enrollment. * Intra-articular steroid injection in the knee and/or use of systemic (oral) corticosteroids within 3 months prior to enrollment. * Intra-articular hyaluronan injection in the treatment knee within 6 months prior to enrollment. * Body Mass Index (BMI) greater than 35.

Locations (1)

London Health Sciences Centre Research

London, Ontario, Canada

Outcomes

Primary Outcomes

WOMAC VAS Pain over 26 weeks

Time frame: 26 weeks post treatment

Secondary Outcomes

WOMAC VAS Stiffness and Function over 26 weeks

Time frame: 26 weeks post treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.