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Safety and Effectiveness Study of Hyaluronic Acid for Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT00653432
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:
Anika Therapeutics, Inc.

Brief Summary:
The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: MONOVISC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: A
Hyaluronic acid
Device: MONOVISC
Intra-articular injection
Other Name: Sodium hyaluronate




Primary Outcome Measures :
  1. WOMAC Pain [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Global Assessment [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic osteoarthritis of the knee

Exclusion Criteria:

  • Disorders which could interfere with assessments

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): NCT00653432


Locations
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United States, Georgia
Resurgens Orthopedics
Cumming, Georgia, United States, 30041
Sponsors and Collaborators
Anika Therapeutics, Inc.

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Responsible Party: Inna Radzihovsky / Clinical Affairs Manager, Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00653432     History of Changes
Other Study ID Numbers: AM-0702
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: June 2010

Keywords provided by Anika Therapeutics, Inc.:
Treatment
Osteoarthritis

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents