Osteoarthritis Initiative (OAI): A Knee Health Study
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ClinicalTrials.gov Identifier: NCT00080171 |
Recruitment Status :
Completed
First Posted : March 25, 2004
Last Update Posted : September 29, 2020
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Condition or disease |
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Osteoarthritis Knee Osteoarthritis |
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 an eight-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 Type : | Observational |
Actual Enrollment : | 4796 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Osteoarthritis Initiative (OAI): A Knee Health Study |
Study Start Date : | February 2004 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | October 2015 |


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Ages Eligible for Study: | 45 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

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): NCT00080171
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21224 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Rhode Island | |
Memorial Hospital of Rhode Island / Brown University | |
Pawtucket, Rhode Island, United States, 02860 |
Study Director: | Gayle Lester, PhD | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00080171 |
Other Study ID Numbers: |
NIAMS-109 |
First Posted: | March 25, 2004 Key Record Dates |
Last Update Posted: | September 29, 2020 |
Last Verified: | March 2009 |
Osteoarthritis Knee Pain Knee Health |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |