Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial
NCT ID: NCT01551264
Last Updated: 2021-11-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
139 participants
INTERVENTIONAL
2012-05-31
2019-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
1 Year
ALL
No
Sponsors
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Shriners Hospitals for Children
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Matthew B Dobbs, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Shriners Hospital for Children
Sacramento, California, United States
Nemours Children's Hospital
Orlando, Florida, United States
Shriners Hospital for Children
Lexington, Kentucky, United States
Washington University School of Medicine
St Louis, Missouri, United States
Shriners Hospital for Children
St Louis, Missouri, United States
Shriners Hospital for Children
Portland, Oregon, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201110158
Identifier Type: -
Identifier Source: org_study_id