Hydros Joint Therapy and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis (OA)
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ClinicalTrials.gov Identifier: NCT01134406 |
Recruitment Status :
Completed
First Posted : June 2, 2010
Last Update Posted : November 3, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis of the Knee | Device: Hydros Joint Therapy Device: Hydros-TA Joint Therapy Device: Synvisc-One | Phase 2 |
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 (Clinical Trial) |
Actual Enrollment : | 98 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Hydros Joint Therapy
Experimental viscosupplement.
|
Device: Hydros Joint Therapy
Single intra-articular injection.
Other Name: Hydros |
Experimental: Hydros-TA Joint Therapy
Experimental viscosupplement.
|
Device: Hydros-TA Joint Therapy
Single intra-articular injection
Other Name: Hydros-TA |
Active Comparator: Synvisc-One
Commercial control.
|
Device: Synvisc-One
Single intra-articular injection.
Other Name: Hylan G-F 20 |
- WOMAC VAS Pain over 26 weeks [ Time Frame: 26 weeks post treatment ]
- WOMAC VAS Stiffness and Function over 26 weeks [ Time Frame: 26 weeks post treatment ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134406
Canada, Ontario | |
London Health Sciences Centre Research | |
London, Ontario, Canada, N6A 4G5 |
Responsible Party: | Carbylan Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT01134406 |
Other Study ID Numbers: |
COR 1.0 |
First Posted: | June 2, 2010 Key Record Dates |
Last Update Posted: | November 3, 2011 |
Last Verified: | November 2011 |
Osteoarthritis knee |
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Hylan Viscosupplements Protective Agents Physiological Effects of Drugs |