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

A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of Hydros Joint Therapy and Hydros-TA Joint Therapy for Management of Pain Associated With Osteoarthritis in the Knee

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01134406

Enrollment

Registered

2010-06-02

Start date

2010-04-30

Completion date

2011-10-31

Last updated

2011-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis, knee

Brief 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.

Detailed 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.

Interventions

DEVICEHydros Joint Therapy

Single intra-articular injection.

DEVICEHydros-TA Joint Therapy

Single intra-articular injection

DEVICESynvisc-One

Single intra-articular injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
WOMAC VAS Pain over 26 weeks	26 weeks post treatment

Secondary

Measure	Time frame
WOMAC VAS Stiffness and Function over 26 weeks	26 weeks post treatment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026