Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial
FAB24
1 other identifier
interventional
139
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2012
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2019
CompletedResults Posted
Study results publicly available
November 30, 2021
CompletedNovember 30, 2021
November 1, 2021
7.5 years
March 7, 2012
August 30, 2021
November 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
4-Year Bracing Arm
OTHERThis group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.
2-Year Bracing Arm
OTHERThis group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method.
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Shriners Hospital for Children
Sacramento, California, 95817, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Shriners Hospital for Children
Lexington, Kentucky, 40502, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Shriners Hospital for Children
St Louis, Missouri, 63131, United States
Shriners Hospital for Children
Portland, Oregon, 97239, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (1)
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.
PMID: 27632641RESULT
Results Point of Contact
- Title
- Matthew Dobbs MD
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew B Dobbs, MD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2012
First Posted
March 12, 2012
Study Start
May 1, 2012
Primary Completion
October 15, 2019
Study Completion
October 15, 2019
Last Updated
November 30, 2021
Results First Posted
November 30, 2021
Record last verified: 2021-11