The overall objective of this 3-year project is to determine whether the provision of
realignment therapy in patients with medial knee osteoarthritis (OA) relieves knee pain and
improves function. The researchers will test the hypothesis that compared to control
treatment, the use of realignment therapy (valgus knee brace + motion control shoes +
orthosis) is effective in medial knee OA.
The specific aims are:
- To undertake a 30 week randomized crossover clinical trial in patients with medial knee
osteoarthritis to determine whether provision of realignment therapy leads to lower
pain scores and improved function during the time of this treatment than during the use
of a placebo treatment;
- To perform an open label follow-up study to track use and effectiveness of treatment.
This project will be co-funded by DonJoy Orthopedic, a knee bracing company.
- Trial participants must meet American College of Rheumatology (ACR) criteria for
osteoarthritis with knee pain, aching or stiffness on most of the past 30 days and
evidence on radiograph of a definite osteophyte. In addition, because the
researchers are interested in recruiting persons with medial knee osteoarthritis,
participants will need to have evidence of disease in this compartment on their
radiographs, and not have lateral compartment or patellofemoral compartment disease.
Medial disease is based on definitions used in the researcher's previous publications
as definite radiographic OA + at least grade 1 medial narrowing (0-3 scale) using an
atlas from the Osteoarthritis Research Society International.
- Individuals with clinical evidence of patellofemoral disease or knee pathology (other
than medial compartment OA) likely to be causing their knee pain.
- Individuals who usually use an ambulation aid to walk such as a cane, crutch, walker
or wheel chair.
- Amputation of foot or previous major trauma to foot that would raise concerns about
whether an insert might worsen foot pain. Persons with foot lesions such as sores or
ulcers in which redistributing load in the foot might be dangerous, will be excluded.
- Known neuropathy from diabetes or for other reasons.
- Past history of deep venous thrombosis.
- Pain emanating more from back or hip than from knee as determined by screening
- Low pain score on WOMAC, a widely used and well validated questionnaire to assess
knee symptoms. To evaluate response, the researchers will require that patients have
a minimal score of at least 4 out of 10 on at least 2 of 5 questions, or a total of
greater than 15 out of 50 for the WOMAC pain scale in the eligible knee at
pre-randomization phone call and visit, and at randomization visit. This will allow
us to detect response to treatment if response occurs.
- Planning to move from area within 9 months of study screening
- Symptomatic comorbid disease limits walking more than knee pain (per screening
- Receiving corticosteroid injections in the month prior to starting the trial. No
other treatments will trigger exclusion, although for patients who have been on
glucosamine +/or chondroitin +/or nonsteroidal anti-inflammatory drug (NSAID) the
researchers will require that they must have taken these treatments for at least 2
months prior to onset of trial and to commit to not start a new treatment throughout
- Bilateral total knee replacements (TKR) or plan for TKR in next 6 months for affected
- Known other causes of arthritis including rheumatoid arthritis (RA), systemic lupus
erythematosus (SLE), gout, psoriatic arthritis, pseudogout.
- Failure to pass 4 week run-in test.
- Volunteers in a pre-contemplative state (persons who would not consider realignment
therapy as a therapeutic option for their knee OA).