Clinical Trials Directory

Trials / Completed

CompletedNCT01088828

Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI

The Pma Mouse and the Developmental Basis of Clubfoot: MRI Anatomical Modelling of Human ICTEV (Clubfoot)

Status
Completed
Phase
Study type
Observational
Enrollment
35 (actual)
Sponsor
University of Aberdeen · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

The purpose of this study is to: 1. compare structural variations observed in the calf and foot of the clubfoot mouse model(pma)with human clubfoot patients antenatally and postnatally; 2. identify features that might be used in future large scale studies to delineate a subtype of human clubfoot associated with lack of response to standard 'Ponseti' manipulation treatments.

Detailed description

Clubfoot is a medical condition of the foot known to doctors as "Congenital Talipes Equinovarus (CTEV)", which affects at least 2 per 1000 Scottish births (ISD data). Affected babies are born with one or both feet in an abnormal position. Treatment with plaster casts, and occasionally with surgery, is necessary to get the foot into a normal position. We know from our animal and clinical studies and published work that the normal processes of development of the foot continue through pregnancy and postnatally. Clubfoot has never been studied by MRI antenatally in humans, and examination of the foot before birth may offer aetiological clues, not apparent from a single postnatal scan. Additionally, robust information that will help to understand which features of clubfoot in utero predict a truly affected fetus could be very useful for the clinical care of those suspected to be affected at a 20 week scan. This study will provide preliminary data to determine whether the usefulness of MRI in this context should be explored in future studies.

Conditions

Interventions

TypeNameDescription
OTHERMagnetic Resonance Imaging (MRI) of calf and footDetailed 3-D comparison of MRI scans of children with clubfoot and controls without clubfoot in utero, in untreated infants and in older children who have been treated.

Timeline

Start date
2010-05-01
Primary completion
2011-05-01
Completion
2011-05-01
First posted
2010-03-17
Last updated
2015-11-05

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01088828. Inclusion in this directory is not an endorsement.