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)

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.

Study Overview

• Status: Completed
• Conditions: Clubfoot
• Intervention / Treatment: Other: Magnetic Resonance Imaging (MRI) of calf and foot

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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom, AB24 3FX
    • University of Aberdeen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; 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.	Other: Magnetic Resonance Imaging (MRI) of calf and foot; Detailed 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.; Other Names: MR scan
Group B; Neonates affected by clubfoot (n=10)	Other: Magnetic Resonance Imaging (MRI) of calf and foot; Detailed 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.; Other Names: MR scan
Group C; Control group of unaffected neonates (n=10)	Other: Magnetic Resonance Imaging (MRI) of calf and foot; Detailed 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.; Other Names: MR scan
Group D; Young adults having completed treatment (n=5)	Other: Magnetic Resonance Imaging (MRI) of calf and foot; Detailed 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.; Other Names: MR scan
Group E; Control group of young unaffected adults (n=5)	Other: Magnetic Resonance Imaging (MRI) of calf and foot; Detailed 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.; Other Names: MR scan

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Investigators: Principal Investigator: Zosia H Miedzybrodzka, MBChB, PhD, University of Aberdeen; Principal Investigator: Simon L Barker, FRCS, MD, NHS Grampian Health Board

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: March 16, 2010
• First Submitted That Met QC Criteria: March 16, 2010
• First Posted (Estimate): March 17, 2010

Study Record Updates

• Last Update Posted (Estimate): November 5, 2015
• Last Update Submitted That Met QC Criteria: November 4, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: MRI, clubfoot, CTEV, Congenital Talipes Equinovarus
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity; Foot Deformities
• Other Study ID Numbers: MRC/BM056