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Customized Orthosis for Children With Clubfoot

NCT03853811 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-04-11

No results posted yet for this study

Summary

This study will examine the use of a novel customized Ankle Foot Orthosis (AFO), created using 3D scanning, with children being treated for clubfoot. The AFO is inserted in the standard Mitchell shoe during bracing, following Ponseti casting. The investigators hypothesize that following Ponseti casting, the implementation of customized AFOs with Ponseti bracing will improve patient compliance and functional outcomes as well as lead to fewer relapses in comparison to the standard bracing with Mitchell shoes.

Conditions

  • Congenital Talipes Equinovarus

Interventions

DEVICE

Ankle Foot Orthosis (AFO)

The intervention group will receive the custom AFO to use in their standard Mitchell shoe.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Scott Van Valin, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2022-03-02
Completion
2022-03-02

Countries

  • United States

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 NCT03853811 on ClinicalTrials.gov