This trial is active, not recruiting.

Conditions osteoarthritis, knee osteoarthritis
Sponsor National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator GlaxoSmithKline
Start date February 2004
End date October 2015
Trial size 5000 participants
Trial identifier NCT00080171, NIAMS-109


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Male or female participants from 45 years up to 79 years old.

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

Additional Information

Official title Osteoarthritis Initiative (OAI): A Knee Health Study
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).