Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 139
- Locations
- 11
- Primary Endpoint
- Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 1 Year (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs
Time Frame: From end of bracing treatment until the earliest recurrence up to 1 year (allowing for per-protocol visit window of 1.2 years) after the assigned treatment (2- or 4-year bracing) is discontinued.
Kaplan-Meier recurrence-free survival probability for each limb affected by clubfoot up to 1 year after bracing is discontinued. For patients with bilateral clubfoot, each limb was assessed. Bilateral patients contribute data for both limbs and unilateral patients contribute data for the affected limb. Recurrence is defined as the development of any of the following deformities in isolation or in combination that require repeat cast application or surgical intervention: hindfoot varus, ankle equinus, midfoot adduction, midfoot cavus, or forefoot pronation. Clubfoot recurrence was determined by the local Principal Investigator.
Secondary Outcomes
No secondary outcomes reported