Foot Abduction Brace (FAB)
DeviceAfter 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.
Completed
NCT Number: NCT01551264
Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial
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.
Completed
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Notify MeKey information
Conditions
Age range
Up to 1 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Shriners Hospital for Children, Sacramento, California, United States
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Washington University School of Medicine
Other
Collaborators
- Shriners Hospitals for Children
Registry information
Official study title
Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail
Acronym: FAB24
Important dates
- Study start
- 2012
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Mar 12, 2012
- Registry last updated
- Nov 30, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.