Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI

Completed

• Conditions: Clubfoot
• Interventions: Other: Magnetic Resonance Imaging (MRI) of calf and foot

• Registration Number: NCT01088828
• Lead Sponsor: University of Aberdeen

Brief 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.

Study Timeline

• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Study Start: 2010-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Group A - pregnancies suspected to be affected by clubfoot on detailed scan. Group B - neonates / infants with clubfoot. Age Preferably under 3 months). Group C - neonates / infants without clubfoot.Preferably under 3 months). Group D- young adults who have undergone treatment for clubfoot and are not undergoing further active treatment. Age range 14-30 years.

Group E - young adults without known lower limb pathology. Age 14-30 years.

Exclusion Criteria

For all groups the exclusion criteria are any contraindication to MRI scanning.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group C	Magnetic Resonance Imaging (MRI) of calf and foot	Control group of unaffected neonates (n=10)
Group A	Magnetic Resonance Imaging (MRI) of calf and foot	Foetuses with clubfoot identified in utero (n=15). Of these: * around 10 will be born with clubfoot and will form most of Group B, * around 5 will be born without clubfoot and will form part of group C.
Group B	Magnetic Resonance Imaging (MRI) of calf and foot	Neonates affected by clubfoot (n=10)
Group D	Magnetic Resonance Imaging (MRI) of calf and foot	Young adults having completed treatment (n=5)
Group E	Magnetic Resonance Imaging (MRI) of calf and foot	Control group of young unaffected adults (n=5)

Trial Locations

Locations (1)

University of Aberdeen; 🇬🇧 Aberdeen, United Kingdom