Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Aberdeen.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01088828
First received: March 16, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  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:

Estimated Enrollment: 35
Study Start Date: May 2010
Estimated Study Completion Date: May 2011
Estimated 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Mariella D'Alessandro, PhD 0044 1224 552120 ext 51294 m.dalessandro@nhs.net
Contact: Jane Edwardson, BSc 0044 1224 552120 jane.edwardson@nhs.net

Locations
United Kingdom
University of Aberdeen Not yet recruiting
Aberdeen, United Kingdom, AB24 3FX
Contact: Elizabeth Rattray, PhD    0044 1224 274369    e.rattray@abdn.ac.uk   
Contact: Gail Holland, PhD    0044 1224 55076    g.holland@abdn.ac.uk   
Principal Investigator: Zosia H Miedzybrodzka, PhD, MBChB         
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: Elizabeth Rattray (Dr), University of Aberdeen
ClinicalTrials.gov Identifier: NCT01088828     History of Changes
Other Study ID Numbers: MRC/BM056
Study First Received: March 16, 2010
Last Updated: March 16, 2010
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
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired

ClinicalTrials.gov processed this record on July 20, 2014