NCT00080171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,796

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2004

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2004

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 29, 2020

Status Verified

March 1, 2009

Enrollment Period

11.7 years

First QC Date

March 24, 2004

Last Update Submit

September 25, 2020

Conditions

OsteoarthritisKnee Osteoarthritis

Keywords

OsteoarthritisKnee PainKnee Health

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Memorial Hospital of Rhode Island / Brown University

Pawtucket, Rhode Island, 02860, United States

Location

Related Publications (35)

  • 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.

    PMID: 40822965DERIVED

  • 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.

    PMID: 40484272DERIVED

  • 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.

    PMID: 40423542DERIVED

  • 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.

    PMID: 39287521DERIVED

  • 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.

    PMID: 39230576DERIVED

  • 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.

    PMID: 38686814DERIVED

  • 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.

    PMID: 36583920DERIVED

  • 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.

    PMID: 36576026DERIVED

  • 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.

    PMID: 35727152DERIVED

  • 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.

    PMID: 35638929DERIVED

  • 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.

    PMID: 35245407DERIVED

  • 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.

    PMID: 34619678DERIVED

  • Canton G, Hippe DS, Chen L, Waterton JC, Liu W, Watase H, Balu N, Sun J, Hatsukami TS, Yuan C. Atherosclerotic Burden and Remodeling Patterns of the Popliteal Artery as Detected in the Magnetic Resonance Imaging Osteoarthritis Initiative Data Set. J Am Heart Assoc. 2021 Jun;10(11):e018408. doi: 10.1161/JAHA.120.018408. Epub 2021 May 17.

    PMID: 33998279DERIVED

  • Fuerst D, Wirth W, Gaisberger M, Hunter DJ, Eckstein F. Association of Superficial Cartilage Transverse Relaxation Time With Osteoarthritis Disease Progression: Data From the Foundation for the National Institutes of Health Biomarker Study of the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2022 Nov;74(11):1888-1893. doi: 10.1002/acr.24627. Epub 2022 Jul 12.

    PMID: 33973402DERIVED

  • Hu B, Han D, Nevitt MC, Wise BL, Segal NA. Longitudinal Relationship Between Physical Activity and Joint Space Narrowing: Forty-Eight-Month Follow-Up Data From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2022 Jul;74(7):1163-1171. doi: 10.1002/acr.24554. Epub 2022 Apr 13.

    PMID: 33411980DERIVED

  • Eckstein F, Chaudhari AS, Fuerst D, Gaisberger M, Kemnitz J, Baumgartner CF, Konukoglu E, Hunter DJ, Wirth W. Detection of Differences in Longitudinal Cartilage Thickness Loss Using a Deep-Learning Automated Segmentation Algorithm: Data From the Foundation for the National Institutes of Health Biomarkers Study of the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2022 Jun;74(6):929-936. doi: 10.1002/acr.24539. Epub 2022 Apr 1.

    PMID: 33337584DERIVED

  • Campbell TM, Ramsay T, Trudel G. Knee Flexion Contractures Are Associated with Worse Pain, Stiffness, and Function in Patients with Knee Osteoarthritis: Data from the Osteoarthritis Initiative. PM R. 2021 Sep;13(9):954-961. doi: 10.1002/pmrj.12497. Epub 2020 Nov 10.

    PMID: 32969154DERIVED

  • Roth M, Emmanuel K, Wirth W, Kwoh CK, Hunter DJ, Hannon MJ, Eckstein F. Changes in Medial Meniscal Three-Dimensional Position and Morphology As Predictors of Knee Replacement in Rapidly Progressing Knee Osteoarthritis: Data From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2021 Jul;73(7):1031-1037. doi: 10.1002/acr.24193.

    PMID: 32198847DERIVED

  • Haj-Mirzaian A, Mohajer B, Guermazi A, Conaghan PG, Lima JAC, Blaha MJ, Bingham CO, Roemer FW, Cao X, Demehri S. Statin Use and Knee Osteoarthritis Outcome Measures according to the Presence of Heberden Nodes: Results from the Osteoarthritis Initiative. Radiology. 2019 Nov;293(2):396-404. doi: 10.1148/radiol.2019190557. Epub 2019 Sep 10.

    PMID: 31502936DERIVED

  • Ruhdorfer A, Wirth W, Culvenor AG, Eckstein F. Reduction in Thigh Muscle Strength Occurs Concurrently but Does Not Seem to Precede Incident Knee Pain in Women: Data From the Osteoarthritis Initiative Cohort. Am J Phys Med Rehabil. 2020 Jan;99(1):33-40. doi: 10.1097/PHM.0000000000001271.

    PMID: 31343500DERIVED

  • Wirth W, Maschek S, Roemer FW, Sharma L, Duda GN, Eckstein F. Radiographically normal knees with contralateral joint space narrowing display greater change in cartilage transverse relaxation time than those with normal contralateral knees: a model of early OA? - data from the Osteoarthritis Initiative (OAI). Osteoarthritis Cartilage. 2019 Nov;27(11):1663-1668. doi: 10.1016/j.joca.2019.06.013. Epub 2019 Jul 10.

    PMID: 31301430DERIVED

  • Eckstein F, Maschek S, Roemer FW, Duda GN, Sharma L, Wirth W. Cartilage loss in radiographically normal knees depends on radiographic status of the contralateral knee - data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2019 Feb;27(2):273-277. doi: 10.1016/j.joca.2018.10.006. Epub 2018 Oct 28.

    PMID: 30394330DERIVED

  • Bricca A, Wirth W, Juhl CB, Kemnitz J, Hunter DJ, Kwoh CK, Eckstein F, Culvenor AG. Moderate Physical Activity and Prevention of Cartilage Loss in People With Knee Osteoarthritis: Data From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2019 Feb;71(2):218-226. doi: 10.1002/acr.23791.

    PMID: 30339323DERIVED

  • Jacobs CA, Vranceanu AM, Thompson KL, Lattermann C. Rapid Progression of Knee Pain and Osteoarthritis Biomarkers Greatest for Patients with Combined Obesity and Depression: Data from the Osteoarthritis Initiative. Cartilage. 2020 Jan;11(1):38-46. doi: 10.1177/1947603518777577. Epub 2018 Jun 1.

    PMID: 29855190DERIVED

  • Hu B, Skou ST, Wise BL, Williams GN, Nevitt MC, Segal NA. Lower Quadriceps Rate of Force Development Is Associated With Worsening Physical Function in Adults With or at Risk for Knee Osteoarthritis: 36-Month Follow-Up Data From the Osteoarthritis Initiative. Arch Phys Med Rehabil. 2018 Jul;99(7):1352-1359. doi: 10.1016/j.apmr.2017.12.027. Epub 2018 Jan 31.

    PMID: 29408538DERIVED

  • Wirth W, Hunter DJ, Nevitt MC, Sharma L, Kwoh CK, Ladel C, Eckstein F. Predictive and concurrent validity of cartilage thickness change as a marker of knee osteoarthritis progression: data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2017 Dec;25(12):2063-2071. doi: 10.1016/j.joca.2017.08.005. Epub 2017 Aug 31.

    PMID: 28838858DERIVED

  • Steidle-Kloc E, Culvenor AG, Dorrenberg J, Wirth W, Ruhdorfer A, Eckstein F. Relationship Between Knee Pain and Infrapatellar Fat Pad Morphology: A Within- and Between-Person Analysis From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2018 Apr;70(4):550-557. doi: 10.1002/acr.23326. Epub 2018 Mar 11.

    PMID: 28704603DERIVED

  • Kemnitz J, Wirth W, Eckstein F, Ruhdorfer A, Culvenor AG. Longitudinal change in thigh muscle strength prior to and concurrent with symptomatic and radiographic knee osteoarthritis progression: data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2017 Oct;25(10):1633-1640. doi: 10.1016/j.joca.2017.07.003. Epub 2017 Jul 8.

    PMID: 28698106DERIVED

  • Veronese N, Stubbs B, Noale M, Solmi M, Vaona A, Demurtas J, Nicetto D, Crepaldi G, Schofield P, Koyanagi A, Maggi S, Fontana L. Fried potato consumption is associated with elevated mortality: an 8-y longitudinal cohort study. Am J Clin Nutr. 2017 Jul;106(1):162-167. doi: 10.3945/ajcn.117.154872. Epub 2017 Jun 7.

    PMID: 28592612DERIVED

  • Wirth W, Maschek S, Beringer P, Eckstein F. Subregional laminar cartilage MR spin-spin relaxation times (T2) in osteoarthritic knees with and without medial femorotibial cartilage loss - data from the Osteoarthritis Initiative (OAI). Osteoarthritis Cartilage. 2017 Aug;25(8):1313-1323. doi: 10.1016/j.joca.2017.03.013. Epub 2017 Mar 27.

    PMID: 28351705DERIVED

  • Veronese N, Stubbs B, Noale M, Solmi M, Luchini C, Maggi S. Adherence to the Mediterranean diet is associated with better quality of life: data from the Osteoarthritis Initiative. Am J Clin Nutr. 2016 Nov;104(5):1403-1409. doi: 10.3945/ajcn.116.136390. Epub 2016 Sep 28.

    PMID: 27680996DERIVED

  • Collins JE, Deshpande BR, Katz JN, Losina E. Race- and Sex-Specific Incidence Rates and Predictors of Total Knee Arthroplasty: Seven-Year Data From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2016 Jul;68(7):965-73. doi: 10.1002/acr.22771.

    PMID: 26554629DERIVED

  • Eckstein F, Collins JE, Nevitt MC, Lynch JA, Kraus VB, Katz JN, Losina E, Wirth W, Guermazi A, Roemer FW, Hunter DJ; FNIH OA Biomarkers Consortium. Brief Report: Cartilage Thickness Change as an Imaging Biomarker of Knee Osteoarthritis Progression: Data From the Foundation for the National Institutes of Health Osteoarthritis Biomarkers Consortium. Arthritis Rheumatol. 2015 Dec;67(12):3184-9. doi: 10.1002/art.39324.

    PMID: 26316262DERIVED

  • Eckstein F, Kwoh CK, Link TM; OAI investigators. Imaging research results from the osteoarthritis initiative (OAI): a review and lessons learned 10 years after start of enrolment. Ann Rheum Dis. 2014 Jul;73(7):1289-300. doi: 10.1136/annrheumdis-2014-205310. Epub 2014 Apr 12.

    PMID: 24728332DERIVED

  • Baum T, Joseph GB, Arulanandan A, Nardo L, Virayavanich W, Carballido-Gamio J, Nevitt MC, Lynch J, McCulloch CE, Link TM. Association of magnetic resonance imaging-based knee cartilage T2 measurements and focal knee lesions with knee pain: data from the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2012 Feb;64(2):248-55. doi: 10.1002/acr.20672.

    PMID: 22012846DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Gayle Lester, PhD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2004

First Posted

March 25, 2004

Study Start

February 1, 2004

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 29, 2020

Record last verified: 2009-03

Locations

US(5)