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

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03580746
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 0

Study Details

Study Description

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	Phase
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.

Study Design

• 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
• Anticipated Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Jun 1, 2015
• Anticipated Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Clinical results [1 year]

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

Secondary Outcome Measures

1. Gait analysis [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Days to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals of Leuven	Pellenberg	Vlaams-Brabant	Belgium

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT03580746
• Other Study ID Numbers: UZLeuvenColette
• First Posted: Jul 9, 2018
• Last Update Posted: Mar 2, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Clubfoot; Talipes; Equinus Deformity

Study Results

No Results Posted as of Mar 2, 2021