Bracing the Patellofemoral Osteoarthritis: A Clinical Trial

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Osteoarthritis (OA) is a significant public health challenge, being ranked as the leading cause of disability in elders. Relatively little heed has been paid to studying or treating the patellofemoral (PF) joint in OA, despite suggestions that disease there may be strongly correlated with lower extremity disability. The specific aims of this proposal are: 1) To undertake a 20 week randomized crossover clinical trial in patients with patellofemoral osteoarthritis to determine whether provision of patellofemoral bracing leads to lower pain scores and improved function during the time of this treatment than during the use of a placebo treatment; 2) To perform an open label follow-up study to track use and effectiveness of treatment. We propose a double blind, randomized crossover trial of a patellofemoral bracing for patients with patellofemoral osteoarthritis with the primary outcome being knee pain as assessed by the VAS scale on movement, and pain during an aggravating activity nominated by the participant. The two treatments will be as follows: TREATMENT A (CONTROL), a neutral brace without the donut (buttress) and realigning strap and TREATMENT B (ACTIVE), a patellofemoral brace (DonJoy Tru-pull advanced). A run-in design will be used to maximize the likelihood of recruiting subjects who will remain in the trial. Subjects will be randomized to treatment A or B for 6 weeks, with an 8 week washout. For each subject, the trial will last 20 weeks. Study evaluation will take place at the Boston University Medical Center GCRC. The subject's will then be followed for 6 months in an open-label follow-up. Recent estimates suggest that symptomatic knee OA occurs in 13% of persons age 60 and over. There has been a remarkable neglect of physical treatment modalities that is, in part, a consequence of drug development opportunities. The need to develop treatment approaches that are capable of ameliorating the symptoms of OA is an important research objective. This project constitutes an attempt to test a promising physical treatment modality. The short-term outcomes of this project will be to assess the efficacy of knee bracing for pain and disability in patellofemoral osteoarthritis. The longer-term outcome of demonstrating efficacy of such an intervention will be to reduce pain and disability arising from patellofemoral osteoarthritis in the wider community.