Custom-fit versus premanufactured braces.

Custom-made and off-the-shelf functional knee orthoses from four manufacturers were evaluated. Anterior tibial translation testing was performed using a pneumatic mechanical surrogated knee. The mechanical surrogate was interfaced with a servohydraulic materials testing system, which applied all anterior/posterior displacements to an ultimate anterior load of 400 N. Comparison of the individual custom versus premanufactured braces showed that the custom braces demonstrated a statistically significant difference for restraining anterior displacement (P=.0001 to P=.0005). Pooled data from all tests showed that the custom brace measurements as a group restrained anterior displacement better than the premanufactured brace group by a mean difference of 0.84 mm (P=.0001). The authors question whether such small, sub-millimeter findings between custom and off-the-shelf functional derotation braces represent any clinically significant differences.