An interventional study of Knee sleeve in Knee Arthritis, Osteoarthritis, sponsored by Margaret L Gourlay, MD, MPH. Recruiting at 1 site in United States. Open to participants aged 50 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Margaret L Gourlay, MD, MPH · Not applicable, Interventional, and Prevention
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 baseline, 3 months and annually. A prespecified interim analysis of the 1-year KOOS subscore data will be performed.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 235 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →This is the only study on the registry with Margaret L Gourlay, MD, MPH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily knee sleeve use
Device: Knee sleeve
No knee sleeve use
Daily use of one of the following: * Mueller 4-way Stretch Knee Support * Mueller FIR Knee Support * PhysFlex Knee Brace
Change in radiographic grade of knee osteoarthritis severity
Kellgren-Lawrence radiographic grade 0 (best) to 4 (worst) on standing/weightbearing anterior/posterior (A/P) knee radiograph
Time frame: Change from baseline at 5 years
Change in knee pain
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)
Change in knee function
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)
Change in knee-related quality of life
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 1 year (also assessed at 3 months and annually years 2-5)
Proportion of participants with incident arthroscopic knee procedure or knee replacement surgery
Participant report or medical documentation of arthroscopic knee procedure or knee replacement surgery
Time frame: Change from baseline at 5 years
Proportion of participants with patellar instability
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)
Time frame: Change from baseline at 5 years
Started Oct 2026 (actual). Primary completion is estimated for Sep 2032, 71 months after the start.
Of 578 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 71 months is above that.
Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 27, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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