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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. |
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| 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. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Cohort, Prospective | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Osteoarthritis Knee Osteoarthritis |
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| Intervention † | |||||
| MEDLINE PMIDs | |||||
| Links | Click here for the Osteoarthritis Initiative [OAI] Web site. ![]() |
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| 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:
Exclusion Criteria:
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| 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 |
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| Investigators † |
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| 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 | ||||