N/A
Completed N=80
Knee Bracing for People With Patellofemoral Osteoarthritis
Source: ClinicalTrials.gov NCT00381563 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Change in Pain on the VIsual Analog Scale (VAS) — -.068 change in units on a scale from baseline
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, stiffness, and inflammation. Studies have suggested that symptoms of knee osteoarthritis may be caused by abnormalities at the patellofemoral joint, which is the joint between the kneecap, called the patella, and the thigh bone, called the femur. This study will determine whether wearing a knee brace that realigns the patella over the femur is effective in relieving pain and improving function in adults with knee osteoarthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain on the VIsual Analog Scale (VAS) |
-.068 | — |
| PRIMARY Change in WOMAC Pain Scale |
-0.11 | — |
| SECONDARY Change in WOMAC Function Scale |
-0.02 | — |
Eligibility Criteria
Inclusion Criteria
- Knee pain on most days
- Either isolated patellofemoral osteoarthritis or mixed patellofemoral and tibiofemoral osteoarthritis, as based on x-ray
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00381563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.