Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI
Recruitment status was Not yet recruiting
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Purpose
The purpose of this study is to:
- compare structural variations observed in the calf and foot of the clubfoot mouse model(pma)with human clubfoot patients antenatally and postnatally;
- 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) |
| 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:
|
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 |
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
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| 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 |
| 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 | |
| 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 May 16, 2013