NCT03580746

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

September 23, 2014

Last Update Submit

March 1, 2021

Conditions

Clubfoot

Outcome Measures

Primary Outcomes (1)

  • Clinical results

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

    1 year

Secondary Outcomes (1)

  • Gait analysis

    1 year

Study Arms (2)

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

Taping and posteromedial releasePROCEDURE
Taping and posteromedial release
PonsetiPROCEDURE
Treatment by Ponseti

Eligibility Criteria

Age2 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All patients with talipes equinovarus who have been treated at our institution

You may not qualify if:

  • Patients with other disorders which may influence the clinical or gait analysis outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leuven

Pellenberg, Vlaams-Brabant, Belgium

Location

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

July 9, 2018

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

March 2, 2021

Record last verified: 2021-03

Locations

BE(1)