An interventional study of Foot Abduction Brace (FAB) in Isolated Clubfoot, sponsored by Washington University School of Medicine. Completed at 7 sites in United States. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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Among 10 studies in Clubfoot with a site in United States — 2 open to participants now, 2 under way, none of them phase 3. Clubfoot · United States.
Among the 10 studies in Clubfoot with a site in United States, this one is the only one that started in 2012, is one of 3 with no phase, and was the 4th registered.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
Browse Clubfoot studies →2 of the 10 studies in Clubfoot with a site in United States are open now. Recruiting first, the newest first:
University of Wisconsin, Madison · Sites in United States
Ages 0 wk–12 wk
Texas Scottish Rite Hospital for Children · Sites in United States
Ages up to 18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 10 Clubfoot studies recruiting now, none (0%) set no upper age limit and 10 (100%) stop at 75 or younger; 9 take children under 18; none take healthy volunteers.
This study: Up to 1 Year · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2012.
This study's enrollment of 139 is above the median of 38 across 40 interventional studies indexed under Clubfoot.
Median enrollment 100 across the 5 interventional studies, 370 across the 5 observational. Of the 8 that completed or were terminated, 4 (50%) have results posted.
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None of the 10 has an industry lead sponsor. The 8 most frequent:
Washington University School of Medicine is the lead sponsor of 1,805 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Washington University School of Medicine has 1 study filed under Clubfoot — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Clubfoot with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method.
Device: Foot Abduction Brace (FAB)
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.
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.
| Milestone | 4-Year Bracing Arm | 2-Year Bracing Arm |
|---|---|---|
| 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 |
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.
| survival probability | 4-Year Bracing Arm | 2-Year Bracing Arm |
|---|---|---|
| Kaplan-Meier Recurrence-Free Survival Probability for Clubfoot Affected Limbs | 0.81 (0.70 to 0.95) | 0.65 (0.52 to 0.80) |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 4-Year Bracing Arm | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
| 2-Year Bracing Arm | 0/69 (0%) | 0/69 (0%) | 0/69 (0%) |
Baseline participants represent the number of participants enrolled and randomized. However, participant could drop out of the study prior to starting the bracing treatment due to eligibility changes or site discontinuation.
| Age, Categorical(Participants) | 4-Year Bracing Arm | 2-Year Bracing Arm | Total |
|---|---|---|---|
| <=18 years | 70 | 69 | 139 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Months) | 4-Year Bracing Arm | 2-Year Bracing Arm | Total |
|---|---|---|---|
| Mean | 1.8 ± 1.7 | 1.8 ± 1.5 | 1.8 ± 1.6 |
| Sex: Female, Male(Participants) | 4-Year Bracing Arm | 2-Year Bracing Arm | Total |
|---|---|---|---|
| Female | 18 | 23 | 41 |
| Male | 52 | 46 | 98 |
| Race (NIH/OMB)(Participants) | 4-Year Bracing Arm | 2-Year Bracing Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 4 | 4 | 8 |
| White | 57 | 59 | 116 |
| More than one race | 3 | 4 | 7 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | 4-Year Bracing Arm | 2-Year Bracing Arm | Total |
|---|---|---|---|
| United States | 70 | 69 | 139 |
| Measure Description: Laterality of isolated clubfoot at enrollment(Participants) | 4-Year Bracing Arm | 2-Year Bracing Arm | Total |
|---|---|---|---|
| Unilateral | 35 | 35 | 70 |
| Bilateral | 35 | 34 | 69 |
| Family history of clubfoot in first-degree relative(Participants) | 4-Year Bracing Arm | 2-Year Bracing Arm | Total |
|---|---|---|---|
| Presence | 9 | 10 | 19 |
| Absence | 61 | 59 | 120 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2012 to primary completion in Oct 2019, 89 months.
Results were first posted in Nov 2021, 2 years 1 month after primary completion.
Of 20 interventional studies with no phase under Clubfoot, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's 89 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine →