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| Name | Class |
|---|---|
| Knee Sleeve Trial Collaborative, LLC | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee sleeve | Experimental | Daily knee sleeve use |
|
| Control | No Intervention | No knee sleeve use |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knee sleeve | Device | Daily use of one of the following:
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline at 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline at 1 year (also assessed at 3 months and annually years 2-5) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline at 5 years |
| Proportion of participants with patellar instability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret L Gourlay, MD, MPH | Contact | 413-213-4655 | info@kneesleevetrial.org |
| Name | Affiliation | Role |
|---|---|---|
| Margaret L Gourlay, MD, MPH | Knee Sleeve Trial Collaborative, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAYUS Radiology | Springfield | Massachusetts | 01107 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D020370 | Osteoarthritis, Knee |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009135 | Muscular Diseases |
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Superiority Randomized Controlled Trial
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Research Radiologist (Assessor of Primary Outcome and other radiographic outcomes) is masked to the randomization assignments
| 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. | 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. | Change from baseline at 1 year (also assessed at 3 months and annually years 2-5) |
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) |
| Change from baseline at 5 years |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |