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Novel Dynamic Foot Abduction Bar for Treatment of Clubfoot

NCT05293743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-05-22

Study results available
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Summary

The goal of this clinical trial is to evaluate a new Dynamic Bar for foot abduction bracing for clubfoot treatment. The main questions that this study aims to answer are:

* How easy is it to recruit and retain participants for a randomized-controlled effectiveness trial of a novel foot abduction bar?
* How does parental perception of child comfort in the Dynamic Bar compare to parental perception of child comfort in standard bars?
* How does patient tolerance of the Dynamic Bar compare patient tolerance of standard bars?
* How effective is the Dynamic Bar at preventing clubfoot recurrence during the bracing phase when the brace is worn as prescribed for a 30-day trial period?

Each participant will be randomized into one of two arms: the experimental arm or the control arm. For the first 30 days, the experimental arm will wear the new Dynamic Bar with standard boots and the control arm will continue wearing their standard bar. After this 30-day period, the experimental arm will return to wearing their standard bar.

Conditions

  • Clubfoot

Interventions

DEVICE

Foot abduction bracing for clubfoot with novel Dynamic Bar

After Ponseti treatment of serial casting and tenotomy for clubfoot, patients are braced full time x 3 months then night time until age 5. This study compares standard bars in a foot abduction brace to our novel Dynamic Bar. This group uses the Dynamic Bar.

DEVICE

Foot abduction bracing for clubfoot with Standard Bar

After Ponseti treatment of serial casting and tenotomy for clubfoot, patients are braced full time x 3 months then night time until age 5. This study compares standard bars in a foot abduction brace to our novel Dynamic Bar. This group uses the Standard Bar.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Maryse Bouchard, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2023-05-24
Completion
2023-05-24

Countries

  • Canada

Study Locations

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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 NCT05293743 on ClinicalTrials.gov