Knee Arthritis, Osteoarthritis
Conditions
Keywords
Osteoarthritis, Arthritis, Joint, Knee, Osteoarthritis, Knee, Pain, Musculoskeletal
Brief summary
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.
Interventions
DEVICEKnee sleeve
Daily use of one of the following: * Mueller 4-way Stretch Knee Support * Mueller FIR Knee Support * PhysFlex Knee Brace
Sponsors
Margaret L Gourlay, MD, MPH
Knee Sleeve Trial Collaborative, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Research Radiologist (Assessor of Primary Outcome and other radiographic outcomes) is masked to the randomization assignments
Intervention model description
Superiority Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 50-64 years at the time of his/her baseline eligibility screening 2. Unilateral or bilateral chronic (≥ 3 months) knee pain 3. Knee circumference between 12" (30 cm) and 22" (56 cm) measured over center of kneecap; or if a larger size is needed, thigh circumference up to 28" (71 cm) measured at 4" ABOVE center of knee cap per manufacturers' size specifications for the knee sleeves used in the intervention 4. English-speaking and able to provide informed consent for study participation
Exclusion criteria
1. History of knee replacement surgery in the painful/affected knee(s) 2. Knee replacement surgery or arthroscopic procedure scheduled or anticipated in the affected knee(s) within 1 year after study eligibility screening 3. Self-reported history or medical documentation of rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis in any joint; peripheral arterial disease or other vascular or circulatory disorder; blood clotting disorder; bleeding disorder or self-reported easy bruising; current treatment with an anticoagulant or antiplatelet agent; immobility; nonambulatory status; knee ligament tear or rupture; or lower extremity fracture requiring internal or external fixation within 1 year before study eligibility screening 4. History of unprovoked falls 5. Current use of a rigid or hinged knee brace made of metal, plastic or fiberglass, or prescription for a knee brace for the affected knee(s) 6. Previous use of a knee sleeve/fabric knee support on the affected knee(s) for over 6 months cumulative time 7. Inability to pull on or remove elasticized knee sleeve from affected knee(s) 8. Kellgren-Lawrence (KL) grade 4 on a baseline standing/weightbearing A/P knee radiograph of the affected knee(s) is excluded because it is the highest KL grade, so a primary outcome event (transition to a higher grade) is impossible. 9. Moderate to severe knee effusion on baseline radiographs of the painful knee(s) is excluded due to the potential risk of harm and discomfort from the compressive effect of a knee sleeve. Individuals with moderate to severe knee effusion during the first screening assessment who are otherwise eligible will be invited to have a repeat A/P knee x-ray 2 months later to reassess radiological eligibility. If the effusion is mild or has resolved by that time, the individual will be invited to enroll in the study. 10. Pregnancy (because of x-ray exposure) 11. Cannot attend a 5-year study assessment for follow-up knee radiographs 12. Investigator discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in radiographic grade of knee osteoarthritis severity | Change from baseline at 5 years | Kellgren-Lawrence radiographic grade 0 (best) to 4 (worst) on standing/weightbearing anterior/posterior (A/P) knee radiograph |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in knee pain | 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. |
| Change in knee function | 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. |
| Change in knee-related quality of life | 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. |
Countries
United States
Contacts
CONTACTMargaret L Gourlay, MD, MPH
PRINCIPAL_INVESTIGATORMargaret L Gourlay, MD, MPH
Knee Sleeve Trial Collaborative, LLC
Outcome results
None listed