Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial

Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail

The goal of this multi-center, randomized, controlled trial is to evaluate the effectiveness of a 2 year versus 4 year bracing protocol in preventing isolated clubfoot recurrence within the first year post-treatment, and to evaluate factors associated with recurrence in isolated clubfoot.

The study is based on the hypothesis that prolonged bracing will reduce clubfoot recurrence. In addition to bracing length, the study will determine if other factors in addition to duration of brace wear are associated with recurrence.

Inclusion Criteria:

• Subject < 1 year of age when treatment initiated at local site
• Confirmed diagnosis of Isolated Clubfoot
• At least one foot demonstrates fixation of the foot in equinus, forefoot adduction, cavus and hindfoot varus
• Deformity was present at birth

Exclusion Criteria:

• Previous foot abduction bracing
• Previous surgical correction (excluding Tenotomy)
• Dysmorphic features, additional anomalies (i.e. congenital heart disease, hypospadias, a genetic syndrome), or developmental delay
• Neurologic cause for clubfoot (i.e. myelomeningocele or sacral agenesis)