Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI
NCT ID: NCT01088828
Last Updated: 2015-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2010-05-31
2011-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
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.
Group B
Neonates affected by clubfoot (n=10)
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.
Group C
Control group of unaffected neonates (n=10)
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.
Group D
Young adults having completed treatment (n=5)
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.
Group E
Control group of young unaffected adults (n=5)
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Group E - young adults without known lower limb pathology. Age 14-30 years.
ALL
Yes
Sponsors
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University of Aberdeen
OTHER
Responsible Party
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Principal Investigators
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Zosia H Miedzybrodzka, MBChB, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Aberdeen
Simon L Barker, FRCS, MD
Role: PRINCIPAL_INVESTIGATOR
NHS Grampian Health Board
Locations
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University of Aberdeen
Aberdeen, , United Kingdom
Countries
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Other Identifiers
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MRC/BM056
Identifier Type: -
Identifier Source: org_study_id
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