A six‐month followup of a randomized trial comparing the efficacy of a lateral‐wedge insole with subtalar strapping and an in‐shoe lateral‐wedge insole in patients with varus deformity osteoarthritis of the knee

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Abstract
Objective To assess the effect of a lateral‐wedge insole with elastic strapping of the subtalar joint on the femorotibial angle in patients with varus deformity of the knee. Methods The efficacy of a wedged insole with subtalar straps and that of a traditional wedged insole shoe insert were compared. Sixty‐six female outpatients with knee osteoarthritis (OA) were randomized (according to birth date) to be treated with either the strapped or the traditional inserted insole. Standing radiographs with unilateral insole use were used to analyze the femorotibial angles for each patient. In both groups, the baseline and 6‐month visual analog scale (VAS) scores for subjective knee pain and the Lequesne index scores for knee OA were compared. Results The 61 patients who completed the 6‐month study were evaluated. At baseline, there was no significant difference in the femorotibial angle (P = 0.66) and the VAS score (P = 0.75) between the 2 groups. At the 6‐month assessment, the 29 subjects wearing the subtalar‐strapped insole demonstrated a significantly decreased femorotibial angle (P < 0.0001) and significantly improved VAS scores (P = 0.001) and Lequesne index scores (P = 0.033) compared with their baseline assessments. These significant differences were not observed in the 32 subjects assigned to the traditional shoe‐inserted wedged insole. Conclusion These results suggest that an insole with a subtalar strap maintained the valgus correction of the femorotibial angle in patients with varus knee OA for 6 months, indicating longer‐term clinical improvement with the strapped insert compared with the traditional insert.