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WithdrawnNCT03580746Updated Mar 2, 2021

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

An observational study in Clubfoot, sponsored by Universitaire Ziekenhuizen KU Leuven. Withdrawn at 1 site in Belgium. Open to participants aged 2 Days to 18 Years. Per ClinicalTrials.gov, last updated 2021-03-02.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Why this study was withdrawn
Resident working on this study left our department

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
0
Ages
2 Days to 18 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Clubfoot

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03

In context

Clubfoot

69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.

Browse Clubfoot studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with other disorders which may influence the clinical or gait analysis outcome
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Taping and posteromedial release

    Children with clubfoots are treated by taping and posteromedial release

    Procedure: Taping and posteromedial release

  • Treatment by Ponseti

    Children with clubfoots are treated by Ponseti

    Procedure: Ponseti

Interventions

  • ProcedureTaping and posteromedial release
  • ProcedurePonseti
06

What researchers measure

Primary outcomes

  1. Clinical results

    Different clinical results between the two groups using AOFAS (American Orthopaedic Foot and Ankle Society) score.

    Time frame: 1 year

Secondary outcomes

  1. Gait analysis

    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

    Time frame: 1 year

07

Study locations

1 site
  • University Hospitals of Leuven
    Pellenberg, Vlaams-Brabant, Belgium
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2014; primary completion for Jun 2015, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2014
First posted
Jul 9, 2018
StartEst.
Sep 2014
Primary completionEst.
Jun 2015
CompletionEst.
Aug 2015
Last update
Mar 2, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03580746
Responsible party
Sponsor
First posted
Jul 9, 2018
Start date
Sep 2014 (estimated)
Primary completion
Jun 2015 (estimated)
Completion
Aug 2015 (estimated)
Last update
Mar 2, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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