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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Isolated Clubfoot

Intervention / Treatment
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* Device: Foot Abduction Brace (FAB)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 4-Year Bracing Arm<br>This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method. | Device: Foot Abduction Brace (FAB)<br>* After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for either 2 or 4 years depending on which arm they are in.<br>|
| Other: 2-Year Bracing Arm<br>This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method. | Device: Foot Abduction Brace (FAB)<br>* After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for either 2 or 4 years depending on which arm they are in.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs | 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. | 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. |