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| Name | Class |
|---|---|
| Shriners Hospitals for Children | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-Year Bracing Arm | Other | This group has been randomized to 4 years of bracing after correction of clubfoot using the Ponseti Method. |
|
| 2-Year Bracing Arm | Other | This group has been randomized to 2 years of bracing after correction of clubfoot using the Ponseti Method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot Abduction Brace (FAB) | Device | 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 | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew B Dobbs, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospital for Children | Sacramento | California | 95817 | United States | ||
| Nemours Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27632641 | Result | 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):101-107. doi: 10.1097/BPB.0000000000000387. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | survival probability | 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. | limb | limb |
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Dobbs MD | Washington University School of Medicine | 561-844-5255 | mdobbs@paleyinstitute.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2011 | Aug 24, 2021 | Prot_SAP_000.pdf |
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| Orlando |
| Florida |
| 32827 |
| United States |
| Shriners Hospital for Children | Lexington | Kentucky | 40502 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Shriners Hospital for Children | St Louis | Missouri | 63131 | United States |
| Shriners Hospital for Children | Portland | Oregon | 97239 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age at study consent | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Measure Description: Laterality of isolated clubfoot at enrollment | Count of Participants | Participants |
|
| Family history of clubfoot in first-degree relative | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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 either 2 or 4 years depending on which arm they are in. |
| OG001 | 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 either 2 or 4 years depending on which arm they are in. |
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| 0 |
| 70 |
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| 70 |
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| 70 |
| EG001 | 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. | 0 | 69 | 0 | 69 | 0 | 69 |
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