Osteoarthritis,Knee
Conditions
Brief summary
The purpose of this study is to investigate opportunities for prevention and treatment of knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and poor pain and physical function outcomes especially among those with early or mild knee symptoms. The goal of the study is to find novel strategies to prevent disease at an early stage and to limit the impact of disease once it has occurred.
Detailed description
MOST study participants in the Existing Cohort (3,026 subjects) were enrolled in the original study in 2003-2005. Surviving Existing Cohort participants without end-stage knee osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up contacts. In addition, in 2016-2018 the cohort will be enriched by the recruitment of an additional 1,500 New Cohort participants with early or mild knee symptoms. The goal of the study is to find novel strategies to prevent disease at an early stage.
Interventions
None listed
Sponsors
University of Iowa
University of Alabama at Birmingham
Boston University
National Institute on Aging (NIA)
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
for New Cohort Participants: * Age 45 to 69 Years (Adult, Senior) * Males and Females * Healthy Volunteers * Community-based Sample
Exclusion criteria
for New Cohort Participants: * Rheumatoid or inflammatory arthritis (based on self-report and use of medications specific to these conditions) * Serious health condition e.g., end-stage renal disease, etc. that would likely limit follow-up to less than 2-3 years * Plan to relocate out of geographic region in next 3 years * Not able to walk without the aid of a person or assistive device * Knee joint replacement surgery in either knee * Neither knee fits in the MRI knee coil (determined during Screening Visit). * Not competent to give informed consent * Advanced structural tibiofemoral or patellofemoral knee OA disease (KL grade 3 or 4) in either knee (Determined by Knee X-ray Screening)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worsening knee pain | Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts) | Worsening knee pain defined as reaching minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain questionnaire |
| Incident cartilage loss on MRI | Change from baseline (144-month) at 168-month follow-up contact | Incidence of cartilage loss on MRI extending to the bone |
| Function loss | Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts) | Defined as minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New onset knee buckling | Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts) | Self-report |
| Onset of constant knee pain | Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts) | Self- report |
| New repeated falls | Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts) | Self-report |
| Worsening on MRI | Change from baseline (144-month) at 168-month follow-up contact | Worsening cartilage scores, bone marrow lesion, or meniscal damage |
| Worsening on X-ray | Change from baseline (144-month) at 168-month follow-up contact | Increased Kellgren-Lawrence (KL) grade score, new KL grade 2 score, or semi-quantitative joint space loss in any compartment |
Countries
United States
Outcome results
None listed