Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial (FAB24)
This study is currently recruiting participants.
Verified April 2013 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01551264
First received: March 7, 2012
Last updated: April 22, 2013
Last verified: April 2013
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Purpose
Prolonged bracing reduces the rate of clubfoot recurrence. In addition to bracing length, other factors, including compliance with bracing, gender, age, severity of clubfoot deformity and family history contribute to clubfoot recurrence.
| Condition | Intervention |
|---|---|
|
Isolated Clubfoot |
Device: Foot Abduction Brace (FAB) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- Establish the time dependent risk for relapse with need for further therapy in isolated clubfoot for 2 year versus 4 year bracing [ Time Frame: 1 year after bracing discontinued ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine whether covariates that include compliance with bracing, gender, age, severity, and family history are associated with relapse [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 124 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
4-Year Bracing Arm
This group has been randomized to 4 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.
|
|
2-Year Bracing Arm
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.
|
Eligibility| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551264
Contacts
| Contact: Matthew B Dobbs, MD | 314-454-4814 | dobbsm@wudosis.wustl.edu |
Locations
| United States, California | |
| Shriners Hospital for Children | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Joel A Lerman, MD 916-453-2039 jlerman@shrinenet.org | |
| Contact: Jason Kawada, MS 916-453-5054 jkawada@shrinenet.org | |
| Principal Investigator: Joel A Lerman, MD | |
| United States, Florida | |
| Nemours Children's Hospital | Recruiting |
| Orlando, Florida, United States, 32827 | |
| Contact: Steven L Frick, MD 704-355-3184 steven.frick@nemours.org | |
| Contact: Bert Kesser 407-650-7175 kenneth.kesser@nemours.org | |
| Principal Investigator: Steven L Frick, MD | |
| United States, Kentucky | |
| Shriners Hospital for Children | Recruiting |
| Lexington, Kentucky, United States, 40502 | |
| Contact: Vishwas R Talwalkar, MD 859-268-5625 vtalwalkar@shrinenet.org | |
| Contact: Chandra Lloyd 859-266-2101 ext 1214 chlloyd@shrinenet.org | |
| Principal Investigator: Vishwas R Talwalkar, MD | |
| United States, Missouri | |
| Shriners Hospital for Children | Recruiting |
| St. Louis, Missouri, United States, 63131 | |
| Contact: Matthew B Dobbs, MD 314-454-4814 dobbsm@wudosis.wustl.edu | |
| Contact: Kelly A Herberger, RN 314-872-8342 ext 1380 kherberger@shrinenet.org | |
| Principal Investigator: Matthew B Dobbs, MD | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Matthew B Dobbs, MD 314-454-4814 dobbsm@wudosis.wustl.edu | |
| Contact: Lindsay Brockmeier 314-454-4113 brockmeierl@wudosis.wustl.edu | |
| Principal Investigator: Matthew B Dobbs, MD | |
| United States, Oregon | |
| Shriners Hospital for Children | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Ellen Raney, MD 503-221-3486 eraney@shrinenet.org | |
| Contact: Susan Thomas, MA 503-221-3481 SST@shcc.org | |
| Principal Investigator: Ellen Raney, MD | |
| United States, Pennsylvania | |
| Shriners Hospital for Children | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Harold JP van Bosse, MD 215-430-4032 hvanbosse@shrinenet.org | |
| Contact: Teaa Davis 215-430-4296 tedavis@shrinenet.org | |
| Principal Investigator: Harold JP van Bosse, MD | |
| United States, Washington | |
| Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Vincent S Mosca, MD 206-987-6079 vincent.mosca@seattlechildrens.org | |
| Contact: Rebecca Vest 206-987-0041 rebecca.vest@seattlechildrens.org | |
| Principal Investigator: Vincent S Mosca, MD | |
Sponsors and Collaborators
Washington University School of Medicine
Shriners Hospitals for Children
Investigators
| Principal Investigator: | Matthew B Dobbs, MD | Washington University School of Medicine |
More Information
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01551264 History of Changes |
| Other Study ID Numbers: | 201110158 |
| Study First Received: | March 7, 2012 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Clubfoot Equinus Deformity Foot Deformities, Congenital |
Foot Deformities Musculoskeletal Diseases Foot Deformities, Acquired |
ClinicalTrials.gov processed this record on May 19, 2013