Clinical trial NCT01551264: Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial
Official title: Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Isolated Clubfoot
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2012-03-12
Enrollment: 139
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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)

Primary outcomes:
measure: Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Shriners Hospital for Children
state: California
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Lexington
country: United States
facility: Shriners Hospital for Children
state: Kentucky
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Shriners Hospital for Children
state: Missouri
city: Portland
country: United States
facility: Shriners Hospital for Children
state: Oregon
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Washington University School of Medicine
name: Matthew B Dobbs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.