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Osteoarthritis Initiative (OAI): A Knee Health Study

This study is ongoing, but not recruiting participants.
Study NCT00080171.   Last updated on September 3, 2008.   Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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Descriptive Information Fields
Brief Title  Osteoarthritis Initiative (OAI): A Knee Health Study
Official Title  Osteoarthritis Initiative (OAI): A Knee Health Study
Brief Summary

Knee osteoarthritis (OA) is the most common cause of disability in adults. The "Osteoarthritis Initiative (OAI): A Knee Health Study" is a nationwide research study that will help researchers gather more information about the physical changes that occur prior to the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to examine people who have knee OA or are at high risk for knee OA; information will be used to better understand how to prevent and treat knee OA.

Detailed Description

Knee OA causes more health problems and medical expenses that any other form of arthritis. Symptoms of OA can range from stiffness and mild pain to severe joint pain and even disability. Previous research has shown that certain factors, such as knee pain, prior knee injury or knee surgery, OA of the hand, or obesity, may lead to knee OA. The OAI is a multicenter, observational study of knee OA that will collect information on potential biomarkers for OA and trends in OA onset and progression.

The OAI will recruit and follow participants who have knee OA or are at high risk for developing knee OA for at least a four-year period at one of four clinical centers. Blood and urine collection, magnetic resonance imaging (MRI), and X-rays will be completed at each of four annual follow-up visits. A questionnaire and physical examination at screening will assess for risk factors for the development and progression of knee OA. Levels of knee pain and physical disability will be assessed at study start and at each of the follow-up visits by questionnaire and examination.

Study Phase
Study Type  Observational
Study Design  Cohort, Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Osteoarthritis
Knee Osteoarthritis
Intervention 
MEDLINE PMIDs
Links Click here for the Osteoarthritis Initiative [OAI] Web site. This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  5000
Start Date  February 2004
Completion Date June 2009
Eligibility Criteria 

Inclusion Criteria:

Must meet one of the following criteria:

  • Overweight
  • Previous knee injury or surgery
  • Knee pain during the past year. Participants do not need to have current knee pain to take part in the study.
  • Parent or sibling who had knee replacement

Exclusion Criteria:

  • Rheumatoid arthritis
  • Joint replacements in both knees
  • Unable to walk without assistance
  • Unable to undergo MRI of the knee
Gender Both
Ages 45 Years to 79 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00080171
Organization ID NIAMS-109
Secondary IDs ††
Study Sponsor  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators †† GlaxoSmithKline
Merck
Novartis
Pfizer
Investigators 
Study Director:     Gayle Lester, PhD     National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)    
Information Provided By National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Verification Date September 2008
First Received Date  March 24, 2004
Last Updated Date September 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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