Design improvements and clinical evaluation of an adjustable clubfoot splint.

Clubfoot, a congenital deformity affecting 1 to 10 per 1000 live births in India, remains challenging to manage due to high relapse rates following Ponseti method treatment. Conventional foot abduction braces, though essential, often lead to poor compliance because of discomfort and restricted mobility. To address this, a lightweight adjustable clubfoot splint (ACS) is developed for infants up to six months, using a design-for-additive-manufacturing (DFAM) approach to reduce weight, enhance adjustability, and lower cost. The splint allows controlled foot positioning while permitting natural movement, aiming to improve comfort and adherence. Clinical evaluation in 33 infants, supported by computational modeling and simulations, demonstrated a 94% compliance rate and reduced relapse compared with standard braces. While adjustable splints are already available, many remain rigid, costly, and less accessible in resource-limited settings. The present work contributes a DFAM-based, low-cost, clinically validated splint, offering a practical alternative to improve treatment outcomes and long-term management of clubfoot.