Trial Outcomes & Findings for Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial (NCT NCT01551264)
NCT ID: NCT01551264
Last Updated: 2021-11-30
Results Overview
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.
COMPLETED
NA
139 participants
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.
2021-11-30
Participant Flow
Participant milestones
| Measure |
4-Year Bracing Arm
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.
|
2-Year Bracing Arm
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.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
69
|
|
Overall Study
Started Bracing
|
69
|
67
|
|
Overall Study
Data for at Least One Follow-up After Brace Discontinuation Ascertained
|
44
|
55
|
|
Overall Study
COMPLETED
|
38
|
41
|
|
Overall Study
NOT COMPLETED
|
32
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial
Baseline characteristics by cohort
| Measure |
4-Year Bracing Arm
n=70 Participants
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.
|
2-Year Bracing Arm
n=69 Participants
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
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
1.8 Months
STANDARD_DEVIATION 1.7 • n=5 Participants
|
1.8 Months
STANDARD_DEVIATION 1.5 • n=7 Participants
|
1.8 Months
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
69 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Measure Description: Laterality of isolated clubfoot at enrollment
Unilateral
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Measure Description: Laterality of isolated clubfoot at enrollment
Bilateral
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Family history of clubfoot in first-degree relative
Presence
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Family history of clubfoot in first-degree relative
Absence
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
PRIMARY outcome
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.Population: 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.
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.
Outcome measures
| Measure |
4-Year Bracing Arm
n=65 limb
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.
|
2-Year Bracing Arm
n=82 limb
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.
|
|---|---|---|
|
Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs
|
0.81 survival probability
Interval 0.7 to 0.95
|
0.65 survival probability
Interval 0.52 to 0.8
|
Adverse Events
4-Year Bracing Arm
2-Year Bracing Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Matthew Dobbs MD
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place