Comparison of Ponseti Method Versus Older Treatments in T... | NCT03580746

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

NCT03580746

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Withdrawn

Last Update Posted

Mar 2, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Clubfoot

Interventions

Taping and posteromedial release
Ponseti

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Resident working on this study left our department

Expanded Access Info

Start Date

Sep 2014Estimated

Primary Completion Date

Jun 2015Estimated

Completion Date

Aug 2015Estimated

First Submitted Date

Sep 23, 2014

First Submission Date that Met QC Criteria

Jun 26, 2018

First Posted Date

Jul 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2021

Last Update Posted Date

Mar 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Taping and posteromedial release	Procedure		Taping and posteromedial release
Ponseti

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical results	Different clinical results between the two groups using AOFAS (American Orthopaedic Foot and Ankle Society) score.	1 year

Secondary Outcomes

Measure	Description	Time Frame
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	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Days

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Leuven		Pellenberg	Vlaams-Brabant		Belgium

Condition Browse Module

MeSH Terms

ID	Term
D003025	Clubfoot

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided