Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial (FAB24)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
139 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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