Abstract
Bracing tolerance during Ponseti treatment is often challenging. Braces that allow more natural leg movement could improve tolerance and comfort, thereby improving outcomes. This manuscript introduces a novel dynamic clubfoot bar design that enables multiplanar movement. It reports on a prospective, assessor-blinded feasibility study in which 11 children aged 1-3 years with idiopathic clubfoot were randomized to wear the novel bar (experimental arm, n = 7) or their original Mitchell-Ponseti standard bar (control arm, n = 4) for 30 days, followed by 60 days of monitoring. Longer-term studies are needed to evaluate efficacy with and without Plantar Flexion Stop boots. This novel bar may be a promising alternative for children who do not tolerate a standard bar or for walking-age children who require extended wear times (ClinicalTrials.gov, [details omitted for blinded peer review]).Key concepts
(1)The novel dynamic clubfoot bar may enable more natural leg movement and increase patient comfort.(2)The novel bar showed no inferiority to the standard bar during a 1-month trial period; however, longer-term studies are required to evaluate efficacy.