Spring Loaded Tri-Compartment Unloader Knee Brace Study (NCT05428332) | Clinical Trial Compass
CompletedNot Applicable
Spring Loaded Tri-Compartment Unloader Knee Brace Study
United States20 participantsStarted 2022-04-05
Plain-language summary
This study will examine clinical outcomes related to pain and function in patients with anterior knee pain (i.e. focal patella and/or trochlea cartilage defect(s), patellofemoral arthritis) before and after standard of care, non-surgical management with and without the addition of a Tri-Compartment Unloader (TCU) knee brace during activities of daily living. Randomly selected participants will wear a TCU brace for several weeks during physical therapy and activities of daily living that is designed to reduce compressive forces in all three compartments of the knee during weight-bearing flexion. Our hypothesis is that TCU bracing will improve clinical outcomes related to pain and function.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Anterior knee pain that worsens when the knee is flexed and bearing weight
✓. Patellofemoral chondral defect(s) or patellofemoral arthritis detected with standard of care x-ray and/or MRI
✓. Kellgren and Lawrence grade 0-3 of PF joint
✓. Able to wear the TCU knee brace for a minimum of 3 hours per day
✓. Over 18 years old, can understand written English
✓. Coronal knee alignment within 7 degrees of neutral
✓. Must be able to fit within an off-the-shelf knee brace size provided by Company
✓. Must complete physical therapy through Stanford
Exclusion criteria
✕. Surgical intervention definitely indicated (major mechanical symptoms/failed substantial previous conservative measures) on the affected knee within the next year
✕
What they're measuring
1
Knee Injury and Osteoarthritis Outcome Score (KOOS)