Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial (FAB24)

This study is ongoing, but not recruiting participants.
Sponsor:
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: October 30, 2013
Last verified: April 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551264

Locations
United States, California
Shriners Hospital for Children
Sacramento, California, United States, 95817
United States, Florida
Nemours Children's Hospital
Orlando, Florida, United States, 32827
United States, Kentucky
Shriners Hospital for Children
Lexington, Kentucky, United States, 40502
United States, Missouri
Shriners Hospital for Children
St. Louis, Missouri, United States, 63131
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Oregon
Shriners Hospital for Children
Portland, Oregon, United States, 97239
United States, Pennsylvania
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States, 19140
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
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: October 30, 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 July 10, 2014