Osteoarthritis Initiative (OAI): A Knee Health Study - Tabular View

Tracking Information

First Received Date ^ICMJE

March 24, 2004

Last Updated Date

March 31, 2009

Start Date ^ICMJE

February 2004

Estimated Primary Completion Date

October 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00080171 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Osteoarthritis Initiative (OAI): A Knee Health Study

Official Title ^ICMJE

Osteoarthritis Initiative (OAI): A Knee Health Study

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Osteoarthritis
Knee Osteoarthritis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

5000

Estimated Completion Date

October 2015

Estimated Primary Completion Date

October 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years to 79 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00080171

Responsible Party

Gayle Lester, PhD, NIAMS

Study ID Numbers ^ICMJE

NIAMS-109

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

GlaxoSmithKline
Merck
Novartis
Pfizer

Investigators ^ICMJE

Study Director:

Gayle Lester, PhD

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

Information Provided By

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

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP