At a glance
ClinicalIndex Comparison RecordN/ACompleted· 139 enrolled
Drug / intervention
Foot Abduction Brace (FAB)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail
In Brief
A clinical study evaluating Foot Abduction Brace (FAB) for Isolated Clubfoot. Completed, enrolled 139 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIsolated Clubfoot
CountriesUnited States
CollaboratorsShriners Hospitals for Children
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartMay 2012
Primary CompletionOct 2019
TodayJul 2026
First PostedMar 12, 2012
Enrollment StartMay 1, 2012
Primary CompletionOct 15, 2019
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 14.3 years ago
Interventions
Foot Abduction Brace (FAB)device
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.