Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI

University of Aberdeen

Status: Completed

Conditions: Clubfoot

Treatments: Other: Magnetic Resonance Imaging (MRI) of calf and foot

Study type: Observational

Funder types: Other

Identifiers

NCT01088828

MRC/BM056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

35 participants in 5 patient groups

Group A

Description:

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.

Treatment:

Other: Magnetic Resonance Imaging (MRI) of calf and foot

Group B

Description:

Neonates affected by clubfoot (n=10)

Treatment:

Other: Magnetic Resonance Imaging (MRI) of calf and foot

Group C

Description:

Control group of unaffected neonates (n=10)

Treatment:

Other: Magnetic Resonance Imaging (MRI) of calf and foot

Group D

Description:

Young adults having completed treatment (n=5)

Treatment:

Other: Magnetic Resonance Imaging (MRI) of calf and foot

Group E

Description:

Control group of young unaffected adults (n=5)

Treatment:

Other: Magnetic Resonance Imaging (MRI) of calf and foot