Osteoarthritis Initiative (OAI): A Knee Health Study

NCT ID: NCT00080171

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4796 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2015-10-31

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.

Conditions

Osteoarthritis; Knee Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gayle Lester, PhD

Role: STUDY_DIRECTOR

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Locations

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Ohio State University

Columbus, Ohio, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Memorial Hospital of Rhode Island / Brown University

Pawtucket, Rhode Island, United States

Countries

United States

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Related Links

http://www.oai.ucsf.edu

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

Other Identifiers

NIAMS-109

Identifier Type: -

Identifier Source: org_study_id