Clinical trial NCT01088828: Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI
Official title: The Pma Mouse and the Developmental Basis of Clubfoot: MRI Anatomical Modelling of Human ICTEV (Clubfoot)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clubfoot
Keywords: MRI, clubfoot, CTEV, Congenital Talipes Equinovarus
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group A: Pregnant women carrying a foetus with suspected clubfoot. Group B: Neonates affected by clubfoot Group C: Unaffected neonates Group D: Young adults who have undergone treatment for clubfoot Group E: Control group of young unaffected adults

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: University of Aberdeen
Study officials:
affiliation: University of Aberdeen
name: Zosia H Miedzybrodzka, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Grampian Health Board
name: Simon L Barker, FRCS, MD
role: PRINCIPAL_INVESTIGATOR
References: