N/A
N=139
Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial
Isolated Clubfoot
Bottom Line
View on ClinicalTrials.gov: NCT01551264 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs — 0.81; 0.65 survival probability — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foot Abduction Brace (FAB) (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs |
0.81; 0.65 | 0.03 sig |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01551264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.