Status:
COMPLETED
Knee Bracing for People With Patellofemoral Osteoarthritis
Lead Sponsor:
Boston University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Osteoarthritis, sometimes called degenerative joint disease, is the most common form of arthritis. It occurs when the cartilage in joints wears down over time. Symptoms can include pain, tenderness, s...
Detailed Description
Bending and straightening at the knee causes the patella to glide along a groove in the femur bone. However, biomechanical imbalances can cause the patella to jump off track, which can lead to pain. I...
Eligibility Criteria
Inclusion
- Knee pain on most days
- Either isolated patellofemoral osteoarthritis or mixed patellofemoral and tibiofemoral osteoarthritis, as based on x-ray
Exclusion
- Bed- or chair-bound, usually uses an ambulation aid to walk (e.g., cane, crutch, or walker), or uses a wheelchair
- Pain emanating more from the back or hip than from the knee, as determined by screening questionnaire
- Low pain score on the visual analog scale (VAS) (less than 4 out of 10)
- Plans to move from the area within 10 months of study screening
- Symptomatic comorbid disease that limits activities more than knee pain does, as determined by screening questionnaire (e.g., congestive heart failure, chronic obstructive pulmonary disease)
- Receiving corticosteroid injections in the month before study entry, or receiving hyaluronan in the 6-month period before study entry. No other treatments will result in exclusion, although for patients taking glucosamine and/or chondroitin and/or a non-steroidal anti-inflammatory drug (NSAID), they must have taken these treatments for at least 2 months before study entry and must commit to not start a new treatment during the study.
- Bilateral total knee replacements or plans for a total knee replacement of the affected knee in the next 6 months
- Morbidly obese (body mass index greater than 35), as brace fitting and prevention of slippage of the brace will be difficult
- Known other causes of arthritis, including rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, and pseudogout
- Skin breakdown at the site where the brace will be applied
- Failure to pass the run-in test, or the brace falls down the leg during the run-in
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00381563
Start Date
December 1 2006
End Date
December 1 2009
Last Update
June 29 2017
Active Locations (2)
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1
Boston University, School of Medicine
Boston, Massachusetts, United States, 02118
2
New England Baptist Hospital
Boston, Massachusetts, United States, 02120