Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial (FAB24)

November 24, 2021 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Shriners Hospital for Children
    • Florida
      • Orlando, Florida, United States, 32827
        • Nemours Children's Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • Shriners Hospital for Children
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School Of Medicine
      • Saint Louis, Missouri, United States, 63131
        • Shriners Hospital for Children
    • Oregon
      • Portland, Oregon, United States, 97239
        • Shriners Hospital for Children
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Shriners Hospitals for Children

Investigators

  • Principal Investigator: Matthew B Dobbs, MD, Washington University School Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2012

Primary Completion (ACTUAL)

October 15, 2019

Study Completion (ACTUAL)

October 15, 2019

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (ESTIMATE)

March 12, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201110158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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