Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01088828
First received: March 16, 2010
Last updated: November 4, 2015
Last verified: November 2015
  Purpose

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.

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Pma Mouse and the Developmental Basis of Clubfoot: MRI Anatomical Modelling of Human ICTEV (Clubfoot)

Resource links provided by NLM:


Further study details as provided by University of Aberdeen:

Enrollment: 35
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: MR scan

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01088828

Locations
United Kingdom
University of Aberdeen
Aberdeen, United Kingdom, AB24 3FX
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT01088828     History of Changes
Other Study ID Numbers: MRC/BM056 
Study First Received: March 16, 2010
Last Updated: November 4, 2015
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by University of Aberdeen:
MRI, clubfoot, CTEV, Congenital Talipes Equinovarus

Additional relevant MeSH terms:
Clubfoot
Equinus Deformity
Congenital Abnormalities
Foot Deformities
Foot Deformities, Acquired
Foot Deformities, Congenital
Limb Deformities, Congenital
Lower Extremity Deformities, Congenital
Musculoskeletal Abnormalities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 08, 2016