Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial

Isolated Clubfoot Clinical Trial

— FAB24  

Official title:

Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551264
• Other study ID #: 201110158
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: October 15, 2019

Study information

• Verified date: November 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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)

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity
• Isolated Clubfoot

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Shriners Hospital for Children	Lexington	Kentucky
United States	Nemours Children's Hospital	Orlando	Florida
United States	Shriners Hospital for Children	Portland	Oregon
United States	Shriners Hospital for Children	Sacramento	California
United States	Shriners Hospital for Children	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):101-10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs	Kaplan-Meier recurrence-free survival probability for each limb affected by clubfoot up to 1 year after bracing is discontinued. For patients with bilateral clubfoot, each limb was assessed. Bilateral patients contribute data for both limbs and unilateral patients contribute data for the affected limb. Recurrence is defined as the development of any of the following deformities in isolation or in combination that require repeat cast application or surgical intervention: hindfoot varus, ankle equinus, midfoot adduction, midfoot cavus, or forefoot pronation. Clubfoot recurrence was determined by the local Principal Investigator.	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.