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

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ClinicalTrials.gov Identifier: NCT03580746
Recruitment Status : Withdrawn (Resident working on this study left our department)
First Posted : July 9, 2018
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease Intervention/treatment
Clubfoot Procedure: Taping and posteromedial release Procedure: Ponseti

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Ponseti Method Versus Older Treatments in Talipes Equinovarus Through Gait Analysis and Clinical Results
Study Start Date : September 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : August 2015

Group/Cohort Intervention/treatment
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



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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Retrospective study of children with club foots treated by two different options.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580746


Locations
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Belgium
University Hospitals of Leuven
Pellenberg, Vlaams-Brabant, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03580746    
Other Study ID Numbers: UZLeuvenColette
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Clubfoot
Talipes
Equinus Deformity
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities