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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carbylan BioSurgery, Inc.
ClinicalTrials.gov Identifier:
NCT01134406
First received: May 5, 2010
Last updated: November 2, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Osteoarthritis of the Knee
 Device: Hydros Joint Therapy
Device: Hydros-TA Joint Therapy
Device: Synvisc-One
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Carbylan BioSurgery, Inc.:

Primary Outcome Measures:
  • WOMAC VAS Pain over 26 weeks [ Time Frame: 26 weeks post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC VAS Stiffness and Function over 26 weeks [ Time Frame: 26 weeks post treatment ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134406

Locations
Canada, Ontario
London Health Sciences Centre Research
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
Carbylan BioSurgery, Inc.
  More Information

No publications provided

Responsible Party: Carbylan BioSurgery, Inc.
ClinicalTrials.gov Identifier: NCT01134406     History of Changes
Other Study ID Numbers: COR 1.0
Study First Received: May 5, 2010
Last Updated: November 2, 2011
Health Authority: Canada: Health Canada
Belgium: Institutional Review Board
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Carbylan BioSurgery, Inc.:
Osteoarthritis
knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013