Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method

December 31, 2020 updated by: Hospices Civils de Lyon
We aim at finding prognostic factors of long term (after growth) function outcome in patient with clubfoot treated by ponseti method, based on a very complete prospective recording of treatment variables and outcome

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

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

  • France
      • Lyon, France
        • Hopital Femme Mere Enfants

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

3 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated by ponseti method

Description

Inclusion Criteria:

  • - Patients treated by ponseti method for clubfoot-

Exclusion Criteria:

  • - other malformation associated / congenital

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ponseti
Patients treated by ponseti method
Other: ponseti
Standard of care, treatment by ponseti method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function at >16 years
Time Frame: at 18 years old or complete bone maturity
Composite score (perfect or non-perfect function), perfect foot defined as a plantigrade, non painful, valgus barefoot with >10° dorsal flexion. Non-perfect otherwise.
at 18 years old or complete bone maturity

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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 (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

December 31, 2020

First Posted (ACTUAL)

January 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 31, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20_5080

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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