title: Design and descriptive data of the randomized Clubfoot Foot Abduction Brace Length of Treatment Study (FAB24).
abstract: The aim of this study was to describe the design and baseline characteristics of participants enrolled in the prospective randomized-controlled Clubfoot Foot Abduction Brace Length of Treatment Study (FAB24). Foot abduction bracing is currently the standard of care for preventing clubfoot relapse. Current recommendations include full-time bracing for the first 3 months and then 8-12 h a day for 4 years; however, the optimal length of bracing is not known. The FAB24 trial is a clinical randomized study to determine the effectiveness of 2- versus 4-year foot abduction bracing. Participant enrollment for FAB24 was conducted at eight sites in North America and included enrollment and randomization of 139 participants with isolated clubfoot. This clinical trial will generate evidence-based data that will inform and improve patient care.
authors.affiliation: aDepartments of Orthopaedic Surgery bNeurology cPediatrics dDivision of Biostatistics, Washington University eShriners Hospital for Children, St Louis, Missouri fNemours Children's Hospital, Orlando, Florida gSeattle Children's Hospital, Seattle, Washington hShriners Hospital for Children, Portland, Oregon iShriners Hospital for Children, Philadelphia, Pennsylvania jShriners Hospital for Children, Sacramento, California kShriners Hospital for Children, Lexington, Kentucky, USA.
authors.forename: Matthew B
authors.initials: MB
authors.lastname: Dobbs
authors.forename: Steven L
authors.initials: SL
authors.lastname: Frick
authors.forename: Vincent S
authors.initials: VS
authors.lastname: Mosca
authors.forename: Ellen
authors.initials: E
authors.lastname: Raney
authors.forename: Harold J
authors.initials: HJ
authors.lastname: VanBosse
authors.forename: Joel A
authors.initials: JA
authors.lastname: Lerman
authors.forename: Vishwas R
authors.initials: VR
authors.lastname: Talwalkar
authors.forename: Karen
authors.initials: K
authors.lastname: Steger-May
authors.forename: Christina A
authors.initials: CA
authors.lastname: Gurnett
mesh_terms: D001915:Braces; D002370:Casts, Surgical; D002648:Child; D002675:Child, Preschool; D003025:Clubfoot / Q000628:therapy*; D019317:Evidence-Based Medicine; D005260:Female; D061826:Foot Orthoses; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010349:Patient Compliance; D011446:Prospective Studies; D012008:Recurrence; D012307:Risk Factors; D055502:Secondary Prevention; D013997:Time Factors; D016896:Treatment Outcome