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

Washington University School of Medicine139 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

139

Conditions

Isolated Clubfoot

Interventions

Foot Abduction Brace (FAB)DEVICE

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.

Eligibility

Sex: ALLMax age: 1 Year

Medical Language ↔ Plain English

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)

Locations (7)

Shriners Hospital for Children

Sacramento, California, United States

Nemours Children's Hospital

Orlando, Florida, United States

Shriners Hospital for Children

Lexington, Kentucky, United States

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

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.

Data from ClinicalTrials.gov

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