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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00653432
First Posted: April 7, 2008
Last Update Posted: October 16, 2017
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.
Information provided by:
Anika Therapeutics, Inc.
  Purpose
The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

Condition Intervention
Osteoarthritis Device: MONOVISC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Anika Therapeutics, Inc.:

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

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

Estimated Enrollment: 350
Study Start Date: January 2008
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Hyaluronic acid
Device: MONOVISC
Intra-articular injection
Other Name: Sodium hyaluronate

  Eligibility

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.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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
United States, Georgia
Resurgens Orthopedics
Cumming, Georgia, United States, 30041
Sponsors and Collaborators
Anika Therapeutics, Inc.
  More Information

Responsible Party: Inna Radzihovsky / Clinical Affairs Manager, Anika Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00653432     History of Changes
Other Study ID Numbers: AM-0702
First Submitted: March 5, 2008
First Posted: April 7, 2008
Last Update Posted: October 16, 2017
Last Verified: June 2010

Keywords provided by Anika Therapeutics, Inc.:
Treatment
Osteoarthritis

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