MedTrace Logo

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

NCT01551264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2021-11-30

Study results available
· View outcomes & findings →

Summary

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.

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.

Sponsors & Collaborators

  • Shriners Hospitals for Children

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Matthew B Dobbs, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2019-10-15
Completion
2019-10-15

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01551264 on ClinicalTrials.gov