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The Use of Botulinum Type A Toxin in the Treatment of Idiopathic Clubfoot: 5-year Follow-up

Background Continued monitoring and reporting of outcomes in clubfoot patients are important for providing an indicator of functional outcomes and surveillance and treatment for problems or recurrences. The purpose of this study is to report the 5-year outcomes of the updated cohort of 44 patients with 65 idiopathic clubfeet treated with manipulation, casting, and Botulinum toxin A (BTX-A). Methods As part of the original study, the patients underwent the corrective treatment phase of manipulation and casting followed with BTX-A injection and then the maintenance phase of bracing. The patients were seen at regular intervals and a detailed clinical history was maintained for each patient including ankle range of motion, recurrences, and interventions for recurrences. Results Mean values for range of motion at the 5-year visit were 22.3 and 17.1 degrees for dorsiflexion with the knee in flexion and extension, respectively. Overall, 48% (31 of 65 clubfeet) successfully responded to a single BTX-A injection and experienced no recurrence over the follow-up period. At least 1 repeat BTX-A injection was required in 34 clubfeet, for an overall recurrence rate of 52%. Surgery was required in 10 clubfeet, and the overall surgical rate was 15.4%. Conclusions Idiopathic clubfeet treated with BTX-A continued to show good outcomes at 2 to 5-year follow-up. The experience with this cohort provides support for the effectiveness of BTX-A in the initial correction and continued management of idiopathic clubfoot. Level of Evidence Levels III to IV. This is a prospective, nonexperimental clinical study investigating efficacy of an innovative treatment.