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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Device: Hydros Joint Therapy
* Device: Hydros-TA Joint Therapy
* Device: Synvisc-One


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydros Joint Therapy<br>Experimental viscosupplement. | Device: Hydros Joint Therapy<br>* Single intra-articular injection.<br>* Other names: Hydros;|
| Experimental: Hydros-TA Joint Therapy<br>Experimental viscosupplement. | Device: Hydros-TA Joint Therapy<br>* Single intra-articular injection<br>* Other names: Hydros-TA;|
| Active Comparator: Synvisc-One<br>Commercial control. | Device: Synvisc-One<br>* Single intra-articular injection.<br>* Other names: Hylan G-F 20;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC VAS Pain over 26 weeks |  | 26 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC VAS Stiffness and Function over 26 weeks |  | 26 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, knee