AzTrials
AzTrials

OsteoarthritisNCT00080171

Osteoarthritis Initiative (OAI): A Knee Health Study

An observational study of Osteoarthritis and Knee Osteoarthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 45 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Osteoarthritis, Knee Osteoarthritis
How many people
4,796 participants
Where
5 sitesUnited States
Study dates
Feb 2004to Oct 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants who have knee OA or are at high risk for developing knee OA

Who may be able to join

  • 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

Who cannot join

  • Rheumatoid arthritis
  • Joint replacements in both knees
  • Unable to walk without assistance
  • Unable to undergo MRI of the knee

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • Ohio State University

    Columbus, Ohio, 43210

  • Memorial Hospital of Rhode Island / Brown University

    Pawtucket, Rhode Island, 02860

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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.

Read the 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.

Keywords
Osteoarthritis, Knee Pain, Knee Health
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2004 (estimated)
  2. Study startFeb 2004
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,796 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00080171
Sponsor's protocol ID
NIAMS-109
Status last verified
Mar 2009
First submitted
24 Mar 2004
Last updated
29 Sep 2020
Results posted
No

Publications

  • Yin X, Li Z, Zhu Y, Liu D, Zhang TJ, Cai S, Wu N. Association of thigh muscle status and longitudinal changes assessed by MRI with subsequent total hip arthroplasty: insights from the osteoarthritis initiative. Arthroplasty. 2026 Sep 1;8(1):64. doi: 10.1186/s42836-026-00423-5.

    PubMed 42675516

  • Pishgar F, Mirghaderi P, Alipour E, Mahmoudian A, Kiadaliri A, Yuan C, Balu N, Guermazi A, Chalian M. Associations of Popliteal Artery Wall Morphology at MRI and Knee Osteoarthritis in the Osteoarthritis Initiative. Radiology. 2026 Aug;320(2):e253583. doi: 10.1148/radiol.253583.

    PubMed 42550019

  • Akkaya Z, Joseph GB, Ziegeler K, Sims WM, Lynch JA, Kreutzinger V, McCulloch CE, Lane NE, Nevitt MC, Link TM. Ultra-processed Foods and Muscle Fat Infiltration at Thigh MRI: Data from the Osteoarthritis Initiative. Radiology. 2026 Apr;319(1):e251129. doi: 10.1148/radiol.251129.

    PubMed 41979462

  • Eckstein F, Chaudhari AS, Hunter DJ, Wirth W. Comparison between coronal FLASH and sagittal double echo steady state MRI in detecting longitudinal cartilage thickness change by fully automated segmentation - Data from the FNIH biomarker cohort. Osteoarthr Cartil Open. 2025 Aug 5;7(3):100657. doi: 10.1016/j.ocarto.2025.100657. eCollection 2025 Sep.

    PubMed 40822965

  • Tore NG, Liles S, Werner DM, Cleveland RJ, Bye TV, Golightly Y, Jakiela JT, White DK. The relation of activity patterns with incident slow gait speed over 4 years in adults with knee osteoarthritis: Data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2025 Sep;33(9):1121-1129. doi: 10.1016/j.joca.2025.06.002. Epub 2025 Jun 6.

    PubMed 40484272

  • Bharadwaj UU, Lynch JA, Joseph GB, Akkaya Z, Nevitt MC, Lane NE, McCulloch CE, Link TM. Intra-articular Knee Injections and Progression of Knee Osteoarthritis: Data from the Osteoarthritis Initiative. Radiology. 2025 May;315(2):e233081. doi: 10.1148/radiol.233081.

    PubMed 40423542

  • Moradi K, Mohammadi S, Roemer FW, Momtazmanesh S, Hathaway Q, Ibad HA, Hunter DJ, Guermazi A, Demehri S. Progression of Bone Marrow Lesions and the Development of Knee Osteoarthritis: Osteoarthritis Initiative Data. Radiology. 2024 Sep;312(3):e240470. doi: 10.1148/radiol.240470.

    PubMed 39287521

  • Wirth W, Maschek S, Wisser A, Eder J, Baumgartner CF, Chaudhari A, Berenbaum F, Eckstein F; OA-BIO Consortium. Evaluation of an automated laminar cartilage T2 relaxation time analysis method in an early osteoarthritis model. Skeletal Radiol. 2025 Mar;54(3):571-584. doi: 10.1007/s00256-024-04786-1. Epub 2024 Sep 4.

    PubMed 39230576

  • Zhang H, Shuai T, Wang J, Li K, Nie Y. Relationship Between 2 Years of Muscle Strength Decrease and Volume Loss of Menisci and Cartilage According to Knee Pain in Mild and Moderate Knee Osteoarthritis. Am J Phys Med Rehabil. 2024 Jan 1;104(1):1-7. doi: 10.1097/PHM.0000000000002507. Epub 2024 Apr 30.

    PubMed 38686814

  • Li M, Nie Y, Zeng Y, Wu Y, Wu L, Liu Y, Shen B. Eight-year trajectories of malalignment progression in symptomatic knee osteoarthritis. Chin Med J (Engl). 2022 Nov 5;135(21):2570-2576. doi: 10.1097/CM9.0000000000002044.

    PubMed 36583920

  • Wirth W, Maschek S, Wisser A, Guermazi A, Hunter DJ, Kwoh CK, Nevitt MC, Eckstein F, Roemer FW. Selection of Knees With Subsequent Cartilage Thickness Loss Based on Magnetic Resonance Imaging Semiquantitative Grading: Data From the Osteoarthritis Initiative Foundation for the National Institutes of Health Biomarker Cohort. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1773-1782. doi: 10.1002/acr.25078. Epub 2023 Feb 22.

    PubMed 36576026

  • Mohajer B, Dolatshahi M, Moradi K, Najafzadeh N, Eng J, Zikria B, Wan M, Cao X, Roemer FW, Guermazi A, Demehri S. Role of Thigh Muscle Changes in Knee Osteoarthritis Outcomes: Osteoarthritis Initiative Data. Radiology. 2022 Oct;305(1):169-178. doi: 10.1148/radiol.212771. Epub 2022 Jun 21.

    PubMed 35727152

  • Li J, Fu S, Gong Z, Zhu Z, Zeng D, Cao P, Lin T, Chen T, Wang X, Lartey R, Kwoh CK, Guermazi A, Roemer FW, Hunter DJ, Ma J, Ding C. MRI-based Texture Analysis of Infrapatellar Fat Pad to Predict Knee Osteoarthritis Incidence. Radiology. 2022 Sep;304(3):611-621. doi: 10.1148/radiol.212009. Epub 2022 May 31.

    PubMed 35638929

  • Lee JJ, Namiri NK, Astuto B, Link TM, Majumdar S, Pedoia V. Personalized Risk Model and Leveraging of Magnetic Resonance Imaging-Based Structural Phenotypes and Clinical Factors to Predict Incidence of Radiographic Osteoarthritis. Arthritis Care Res (Hoboken). 2023 Mar;75(3):501-508. doi: 10.1002/acr.24877. Epub 2022 Dec 10.

    PubMed 35245407

  • Steidle-Kloc E, Dannhauer T, Wirth W, Eckstein F. Responsiveness of Subcutaneous Fat, Intermuscular Fat, and Muscle Anatomical Cross-Sectional Area of the Thigh to Longitudinal Body Weight Loss and Gain: Data from the Osteoarthritis Initiative (OAI). Cells Tissues Organs. 2022;211(5):555-564. doi: 10.1159/000520037. Epub 2021 Oct 7.

    PubMed 34619678

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis and Knee Osteoarthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00080171, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in