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Osteoarthritis Initiative (OAI): A Knee Health Study

Osteoarthritis Initiative (OAI): A Knee Health Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00080171
Enrollment
4796
Registered
2004-03-25
Start date
2004-02-29
Completion date
2015-10-31
Last updated
2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis, Osteoarthritis

Keywords

Osteoarthritis, Knee Pain, Knee Health

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 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.

Interventions

None listed

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Novartis
CollaboratorINDUSTRY
Pfizer
CollaboratorINDUSTRY
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 79 Years
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026