Osteoarthritis Initiative (OAI): A Knee Health Study

Osteoarthritis Clinical Trial

Official title:

Osteoarthritis Initiative (OAI): A Knee Health Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080171
• Other study ID #: NIAMS-109
• Status: Completed
• Start date: February 2004
• Est. completion date: October 2015

Study information

• Verified date: March 2009
• Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4796
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Ohio State University	Columbus	Ohio
United States	Memorial Hospital of Rhode Island / Brown University	Pawtucket	Rhode Island
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	GlaxoSmithKline, Merck Sharp & Dohme Corp., Novartis, Pfizer

Country where clinical trial is conducted

United States, 

External Links

•   Click here for the Osteoarthritis Initiative [OAI] Web site.