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

Completed · Not applicable

Conditions studied: Isolated Clubfoot

In brief

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.

Key facts

Study ID

NCT01551264

Run by

Washington University School of Medicine

People needed

139

Starts

2012-05-01

Expected to finish

2019-10-15

Last updated by the study team

2021-11-30

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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