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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trail

Brief Summary: 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.

Detailed Summary:
Sponsor: Washington University School of Medicine

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Determine whether covariates that include compliance with bracing, gender, age, severity, and family history are associated with relapse [ Time Frame: 5 years ]

Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: March 7, 2012
Date Started: May 2012
Date Completion: December 2016
Last Updated: December 21, 2015
Last Verified: December 2015