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

Not Applicable

Completed

• Conditions: Isolated Clubfoot
• Interventions: Device: Foot Abduction Brace (FAB)

• Registration Number: NCT01551264
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Study Start: 2012-05
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Results First Submitted: 2021-08-30
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-24
• Results First Posted: 2021-11-30
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4-Year Bracing Arm	Foot Abduction Brace (FAB)	This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.
2-Year Bracing Arm	Foot Abduction Brace (FAB)	This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method.

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs	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.

Trial Locations

Locations (4)

Shriners Hospital for Children; 🇺🇸 Portland, Oregon, United States

Nemours Children's Hospital; 🇺🇸 Orlando, Florida, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States