- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580746
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Withdrawn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
Intervention / Treatment
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UZLeuvenColette
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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