RAYUS Radiology
Springfield, Massachusetts, 01107, United States
Location status: Recruiting
NCT Number: NCT07674901
The purpose of this superiority randomized controlled trial is to evaluate the effect of daily knee sleeve use on 5-year radiographic knee osteoarthritis progression and knee-related symptoms in older adults with chronic knee pain. The investigators will recruit 235 individuals aged 50-64 years at baseline with chronic (≥ 3 months) knee pain, randomized to daily use of an elasticized fabric knee sleeve versus no knee sleeve use. Participants will have knee radiographs at baseline and year 5 and will complete a survey including Knee injury and Osteoarthritis Outcome Score (KOOS) subscales for pain, knee function and quality of life at 3 months and annually. A prespecified interim analysis of the 1-year KOOS subscore data will be performed.
Interested in participating?
Request Info50 year–64 year
All sexes
Interventional
Not applicable
Springfield, Massachusetts, 01107, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily use of one of the following:
Time frame: Change from baseline at 5 years
Kellgren-Lawrence radiographic grade 0 (best) to 4 (worst) on standing/weightbearing anterior/posterior (A/P) knee radiograph
Time frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore
The KOOS pain subscale includes 9 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
Time frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
KOOS activities of daily living subscore
The KOOS activities of daily living function subscale includes 17 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
Time frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
KOOS quality of life subscore
The KOOS quality-of-life subscale includes 4 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
Time frame: Change from baseline at 5 years
Participant report or medical documentation of arthroscopic knee procedure or knee replacement surgery
Time frame: Change from baseline at 5 years
Radiographic signs of patellar instability including: 1) patellar tilting, 2) lateral patellar subluxation, 3) interval patellofemoral joint space narrowing by year 5, 4) Insall-Salvati ratio >1.2 (Patella alta)
Interested in participating?
Request InfoMargaret L Gourlay, MD, MPH
Other
A Superiority Randomized Controlled Trial of Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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