FAB24: Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01551264
• Collaborator: Shriners Hospitals for Children (Other)
• Enrollment: 139
• Locations: 7
• Arms: 2
• Actual Duration (Months): 89.5
• Patients Per Site: 19.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Isolated Clubfoot	Device: Foot Abduction Brace (FAB)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail
• Actual Study Start Date: May 1, 2012
• Actual Primary Completion Date: Oct 15, 2019
• Actual Study Completion Date: Oct 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 4-Year Bracing Arm This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.	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.
Other: 2-Year Bracing Arm This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method.	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.

Outcome Measures

Primary Outcome Measures

1. Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs [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.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Year
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shriners Hospital for Children	Sacramento	California	United States	95817
2	Nemours Children's Hospital	Orlando	Florida	United States	32827
3	Shriners Hospital for Children	Lexington	Kentucky	United States	40502
4	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
5	Shriners Hospital for Children	Saint Louis	Missouri	United States	63131
6	Shriners Hospital for Children	Portland	Oregon	United States	97239
7	Seattle Children's Hospital	Seattle	Washington	United States	98105

Sponsors and Collaborators

• Washington University School of Medicine
• Shriners Hospitals for Children

Investigators

• Principal Investigator: Matthew B Dobbs, MD, Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 30, 2011

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01551264
• Other Study ID Numbers: 201110158
• First Posted: Mar 12, 2012
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Additional relevant MeSH terms: Clubfoot; Talipes; Equinus Deformity

Study Results

Participant Flow

Arm/Group Title	4-Year Bracing Arm	2-Year Bracing Arm
Arm/Group Description	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 4 years.	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 2 years.
Period Title: Overall Study
STARTED	70	69
Started Bracing	69	67
Data for at Least One Follow-up After Brace Discontinuation Ascertained	44	55
COMPLETED	38	41
NOT COMPLETED	32	28

Baseline Characteristics

Arm/Group Title	4-Year Bracing Arm	2-Year Bracing Arm	Total
Arm/Group Description	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 4 years.	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 2 years.	Total of all reporting groups
Overall Participants	70	69	139
Age (Count of Participants)
<=18 years	70 100%	69 100%	139 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	1.8 (1.7)	1.8 (1.5)	1.8 (1.6)
Sex: Female, Male (Count of Participants)
Female	18 25.7%	23 33.3%	41 29.5%
Male	52 74.3%	46 66.7%	98 70.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 5.7%	1 1.4%	5 3.6%
Native Hawaiian or Other Pacific Islander	1 1.4%	0 0%	1 0.7%
Black or African American	4 5.7%	4 5.8%	8 5.8%
White	57 81.4%	59 85.5%	116 83.5%
More than one race	3 4.3%	4 5.8%	7 5%
Unknown or Not Reported	1 1.4%	1 1.4%	2 1.4%
Region of Enrollment (participants) [Number]
United States	70 100%	69 100%	139 100%
Measure Description: Laterality of isolated clubfoot at enrollment (Count of Participants)
Unilateral	35 50%	35 50.7%	70 50.4%
Bilateral	35 50%	34 49.3%	69 49.6%
Family history of clubfoot in first-degree relative (Count of Participants)
Presence	9 12.9%	10 14.5%	19 13.7%
Absence	61 87.1%	59 85.5%	120 86.3%

Outcome Measures

1. Primary Outcome

Title	Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

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. Analysis includes limbs from participants who started bracing and attended at least one visit within one year after discontinuing bracing.

Arm/Group Title	4-Year Bracing Arm	2-Year Bracing Arm
Arm/Group Description	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.	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.
Measure Participants	44	55
Measure limb	65	82
Number (95% Confidence Interval) [survival probability]	0.81	0.65

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	4-Year Bracing Arm, 2-Year Bracing Arm
	Comments
	Type of Statistical Test	Other
	Comments	P-value by chi-square comparing the Kaplan-Meier recurrence-free survival probability at 1.2 years post treatment with robust estimate of standard error due to the a priori assumption that data from bilateral limbs are correlated.
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	Adverse events for each participant were evaluated from participant randomization to the last study visit attended. For participants that completed the study, the last study visit is 60 months after brace fitting. For participants that did not complete the study, the last study visit is the final study visit that the participant attended.
Adverse Event Reporting Description	An adverse event is any new untoward medical occurrence or worsening of a preexisting medical condition that occurs in association with study procedures (consent process, questionnaires, loss of protected health information) or treatment reaction in excess of expectation. Serious adverse events require extensive or urgent intervention/corrective action, pose immediate threat of harm, or death. Relatedness is defined as: clearly related, likely related, possibly related, or clearly not related.
Arm/Group Title	4-Year Bracing Arm		2-Year Bracing Arm
Arm/Group Description	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 4 years.		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 2 years.
All Cause Mortality
	4-Year Bracing Arm		2-Year Bracing Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/69 (0%)
Serious Adverse Events
	4-Year Bracing Arm		2-Year Bracing Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/69 (0%)
Other (Not Including Serious) Adverse Events
	4-Year Bracing Arm		2-Year Bracing Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/69 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.