Comparison of Ponseti Method Versus Older Treatments in Talipes Equinovarus Through Gait Analysis and Clinical Results

March 1, 2021 updated by: Universitaire Ziekenhuizen KU Leuven
There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. In this study the investigators should like to demonstrate the better outcome in clinical results and in gait analysis of patients treated with the Ponseti method, compared to the 'older' methods of taping and posteromedial release.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. In this study the invistigators should like to demonstrate the better outcome in clinical results and in gait analysis of patients treated with the Ponseti method, compared to the 'older' methods of taping and posteromedial release. Trial objectives With this study the investigators would like to investigate whether clinical results and gait analysis in patients treated with Ponseti has better results compared to patients treated with the older methods.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vlaams-Brabant
      • Pellenberg, Vlaams-Brabant, Belgium
        • University Hospitals of Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Retrospective study of children with club foots treated by two different options.

Description

Inclusion Criteria:

  • All patients with talipes equinovarus who have been treated at our institution

Exclusion Criteria:

  • Patients with other disorders which may influence the clinical or gait analysis outcome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Taping and posteromedial release
Children with clubfoots are treated by taping and posteromedial release
Treatment by Ponseti
Children with clubfoots are treated by Ponseti

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical results
Time Frame: 1 year
Different clinical results between the two groups using AOFAS (American Orthopaedic Foot and Ankle Society) score.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait analysis
Time Frame: 1 year
Differences in gait analysis between the two groups. While walking barefoot following parameters will be compared: ranges of motion occurring at each joint and each sub phase of stance
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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