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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
Sponsor:
Information provided by (Responsible Party):
Carbylan Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Device: Hydros Joint Therapy Device: Hydros-TA Joint Therapy Device: Synvisc-One Phase 2

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. WOMAC VAS Pain over 26 weeks [ Time Frame: 26 weeks post treatment ]

Secondary Outcome Measures :
  1. WOMAC VAS Stiffness and Function over 26 weeks [ Time Frame: 26 weeks post treatment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Ontario
London Health Sciences Centre Research
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
Carbylan Therapeutics, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Carbylan Therapeutics, Inc.:
Osteoarthritis
knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Hylan
Viscosupplements
Protective Agents
Physiological Effects of Drugs