BACKGROUND: A recent development in valgus-producing knee braces has been the adjustable "unloader" brace. The purpose of this study was to compare the effectiveness of off-the-shelf and custom-made patient-adjustable, valgus-producing knee unloader braces in relieving pain, reducing stiffness, and improving function and in reducing varus angulation and the peak adduction moments about the knee during gait and stair-stepping in patients with painful varus gonarthrosis of the knee. METHODS: Ten adult patients served as their own controls for the measurement of baseline values and then wore each of the two braces, one after the other, for four to five weeks in a random order. Pain, stiffness, and function were assessed with the Western Ontario and McMaster Universities Osteoarthritis Index. Gait and stair-stepping were evaluated with a three-dimensional motion analysis system and multicomponent force platform. Full-length (hip, knee, and ankle) standing anteroposterior radiographs were used to determine alignment of the knee. RESULTS: Both braces significantly reduced pain and stiffness (p < 0.05), with the custom brace reducing stiffness significantly more than the off-the-shelf brace (p = 0.030). The custom brace significantly improved function (p = 0.010) and reduced the peak knee adduction moments during gait (p = 0.033) and stair-stepping (p = 0.002) compared with baseline values and compared with the off-the-shelf brace (p = 0.029 and p = 0.027, respectively). The custom brace significantly reduced varus angulation of the knee by 1.5 degrees compared with baseline (p = 0.001) and by 1.3 degrees compared with the off-the-shelf brace (p = 0.009). The off-the-shelf brace did not significantly reduce the varus angle. CONCLUSIONS: We investigated only the short-term effects of custom and off-the-shelf patient-adjustable valgus-producing knee "unloader" braces and found that patients with varus gonarthrosis of the knee may benefit significantly with respect to pain relief and reduced stiffness from use of either brace. However, such patients may experience additional significant benefit in improved function and reduced stiffness, varus angulation, and medial compartment loading of the knee from use of the custom-made patient-adjustable brace. LEVEL OF EVIDENCE: Therapeutic level II.

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