Clinical trial NCT00080171: Osteoarthritis Initiative (OAI): A Knee Health Study
Official title: Osteoarthritis Initiative (OAI): A Knee Health Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Knee Osteoarthritis
Keywords: Osteoarthritis
Knee Pain
Knee Health
Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sponsor class: NIH
Collaborators: name: GlaxoSmithKline
name: Merck Sharp & Dohme LLC
name: Novartis
name: Pfizer
First posted: 2004-03-25
Enrollment: 4796
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have knee OA or are at high risk for developing knee OA

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island / Brown University
state: Rhode Island
Study officials:
affiliation: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Gayle Lester, PhD
role: STUDY_DIRECTOR
References:
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