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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00653432
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : June 22, 2010
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
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

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.

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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

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 identifier (NCT number): NCT00653432

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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. Identifier: NCT00653432    
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.:
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents