Osteoarthritis Initiative (OAI): A Knee Health Study | NCT00080171

Studies
Osteoarthritis Initiative (OAI): A Knee Health Study

NCT00080171

Sponsor

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

Status

Completed

Last Update Posted

Sep 29, 2020Actual

Enrollment

4,796Actual

Phase

Not provided

Conditions

Osteoarthritis
Knee Osteoarthritis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Mar 24, 2004

First Submission Date that Met QC Criteria

Mar 24, 2004

First Posted Date

Mar 25, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2020

Last Update Posted Date

Sep 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

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

Collaborators

Name	Class
GlaxoSmithKline	INDUSTRY
Merck Sharp & Dohme LLC	INDUSTRY
Novartis	INDUSTRY
Pfizer

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4,796Actual

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gayle Lester, PhD	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland		Baltimore	Maryland	21201	United States
Johns Hopkins University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41979462	Derived	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.
40822965	Derived	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.

ID	Term
D010003	Osteoarthritis
D020370	Osteoarthritis, Knee

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases