Isolated Clubfoot
Conditions
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.
Interventions
DEVICEFoot 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.
Sponsors
Shriners Hospitals for Children
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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. | 69 |
| Total | 139 |
Baseline characteristics
| Characteristic | 4-Year Bracing Arm | 2-Year Bracing Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 70 Participants | 69 Participants | 139 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.8 Months STANDARD_DEVIATION 1.7 | 1.8 Months STANDARD_DEVIATION 1.5 | 1.8 Months STANDARD_DEVIATION 1.6 |
| Family history of clubfoot in first-degree relative Absence | 61 Participants | 59 Participants | 120 Participants |
| Family history of clubfoot in first-degree relative Presence | 9 Participants | 10 Participants | 19 Participants |
| Measure Description: Laterality of isolated clubfoot at enrollment Bilateral | 35 Participants | 34 Participants | 69 Participants |
| Measure Description: Laterality of isolated clubfoot at enrollment Unilateral | 35 Participants | 35 Participants | 70 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 57 Participants | 59 Participants | 116 Participants |
| Region of Enrollment United States | 70 participants | 69 participants | 139 participants |
| Sex: Female, Male Female | 18 Participants | 23 Participants | 41 Participants |
| Sex: Female, Male Male | 52 Participants | 46 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 69 |
| other Total, other adverse events | 0 / 70 | 0 / 69 |
| serious Total, serious adverse events | 0 / 70 | 0 / 69 |
Outcome results
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.
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.
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4-Year Bracing Arm | Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs | 0.81 survival probability |
| 2-Year Bracing Arm | Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs | 0.65 survival probability |
p-value: 0.03Chi-squared