Clubfoot is a 3-dimensional (3D) deformity of the foot and the most common skeletal deformity in children with an incidence of 1-2/1000 births. Without treatment, children develop lifelong difficulties walking and those in low and middle income nations endure abuse and neglect. Under the current standard of care, pediatric orthopedic surgeons use the Ponseti method to gradually change the angle of the foot via weeks of serial casting extending from the toes to mid-thigh. One barrier to successful treatment is physician experience and training, as improper casting technique leads to variable outcomes and in some cases worsening deformity. Family barriers include traveling each week for at least 6 weeks for repeated cycles of the cast being placed, cutoff and replaced. Finally patient complications such as cast saw burns, blisters/ulcers and cast slippage lead to poor adherence to treatment. The BabySteps platform aims to use technology to create a more accessible, practical and standardized treatment of serial clubfoot correction. The solution consists of a software platform that uses predictive modeling and finite analysis to create a set of 3D printed serial casts for the progressive correction of pediatric clubfoot.
Year:
2019
Anticipated Classification:
Class I
Anticipated Regulatory Path:
HDE