Overview

This trial is active, not recruiting.

Condition isolated clubfoot
Treatment foot abduction brace (fab)
Sponsor Washington University School of Medicine
Collaborator Shriners Hospitals for Children
Start date May 2012
End date December 2016
Trial size 124 participants
Trial identifier NCT01551264, 201110158

Summary

Prolonged bracing reduces the rate of clubfoot recurrence. In addition to bracing length, other factors, including compliance with bracing, gender, age, severity of clubfoot deformity and family history contribute to clubfoot recurrence.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.
foot abduction brace (fab)
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.
(Other)
This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method.
foot abduction brace (fab)
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 Outcomes

Measure
Establish the time dependent risk for relapse with need for further therapy in isolated clubfoot for 2 year versus 4 year bracing
time frame: 1 year after bracing discontinued

Secondary Outcomes

Measure
Determine whether covariates that include compliance with bracing, gender, age, severity, and family history are associated with relapse
time frame: 5 years

Eligibility Criteria

Male or female participants up to 1 year old.

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)

Additional Information

Official title Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail
Principal investigator Matthew B Dobbs, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.