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

Sponsor
Carbylan Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01134406
Collaborator
(none)
98
Enrollment
1
Location
3
Arms
18
Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Apr 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hydros Joint Therapy

Experimental viscosupplement.

Device: Hydros Joint Therapy
Single intra-articular injection.
Other Names:
  • Hydros

    		•
    Experimental: Hydros-TA Joint Therapy

    Experimental viscosupplement.

    Device: Hydros-TA Joint Therapy
    Single intra-articular injection
    Other Names:
  • Hydros-TA

    		•
    Active Comparator: Synvisc-One

    Commercial control.

    Device: Synvisc-One
    Single intra-articular injection.
    Other Names:
  • Hylan G-F 20

    		•

    Outcome Measures

    Primary Outcome Measures

    1. WOMAC VAS Pain over 26 weeks [26 weeks post treatment]

    Secondary Outcome Measures

    1. WOMAC VAS Stiffness and Function over 26 weeks [26 weeks post treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 London Health Sciences Centre Research London Ontario Canada N6A 4G5

    Sponsors and Collaborators

    • Carbylan Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carbylan Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01134406
    Other Study ID Numbers:
    • COR 1.0
    First Posted:
    Jun 2, 2010
    Last Update Posted:
    Nov 3, 2011
    Last Verified:
    Nov 1, 2011
    Keywords provided by Carbylan Therapeutics, Inc.
    Osteoarthritis
    knee
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Hylan

    Study Results

    No Results Posted as of Nov 3, 2011