Back to resultsDuration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial (FAB24)
Primary Purpose
Isolated Clubfoot
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Foot Abduction Brace (FAB)
Sponsored by
About this trial
This is an interventional treatment trial for Isolated Clubfoot
Eligibility Criteria
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)
Sites / Locations
- Shriners Hospital for Children
- Nemours Children's Hospital
- Shriners Hospital for Children
- Washington University School of Medicine
- Shriners Hospital for Children
- Shriners Hospital for Children
- Seattle Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
4-Year Bracing Arm
2-Year Bracing Arm
Arm Description
This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.
This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01551264
First Posted
March 7, 2012
Last Updated
November 24, 2021
Sponsor
Washington University School of Medicine
Collaborators
Shriners Hospitals for Children
1. Study Identification
Unique Protocol Identification Number
NCT01551264
Brief Title
Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial
Acronym
FAB24
Official Title
Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Shriners Hospitals for Children
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Isolated Clubfoot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4-Year Bracing Arm
Arm Type
Other
Arm Description
This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.
Arm Title
2-Year Bracing Arm
Arm Type
Other
Arm Description
This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method.
Intervention Type
Device
Intervention Name(s)
Foot Abduction Brace (FAB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs
Description
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.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew B Dobbs, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospital for Children
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Nemours Children's Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Shriners Hospital for Children
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Shriners Hospital for Children
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Shriners Hospital for Children
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27632641
Citation
Dobbs MB, Frick SL, Mosca VS, Raney E, VanBosse HJ, Lerman JA, Talwalkar VR, Steger-May K, Gurnett CA. Design and descriptive data of the randomized Clubfoot Foot Abduction Brace Length of Treatment Study (FAB24). J Pediatr Orthop B. 2017 Mar;26(2):101-107. doi: 10.1097/BPB.0000000000000387.
Results Reference
result
Learn more about this trial
Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial
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