Clinical trial: Knee Bracing for People With Patellofemoral Osteoarthritis (NCT00381563)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment