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

NACompletedINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

October 15, 2019

Study Completion Date

October 15, 2019

Conditions
Isolated Clubfoot
Interventions
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.

Trial Locations (7)

32827

Nemours Children's Hospital, Orlando

40502

Shriners Hospital for Children, Lexington

63110

Washington University School of Medicine, St Louis

63131

Shriners Hospital for Children, St Louis

95817

Shriners Hospital for Children, Sacramento

97239

Shriners Hospital for Children, Portland

98105

Seattle Children's Hospital, Seattle

All Listed Sponsors
collaborator

Shriners Hospitals for Children

OTHER

lead

Washington University School of Medicine

OTHER

NCT01551264 - Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial | Biotech Hunter | Biotech Hunter