An observational study in Clubfoot, sponsored by University of Aberdeen. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2015-11-05.
Sponsored by University of Aberdeen · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
The purpose of this study is to:
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.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's enrollment of 35 is below the median of 55 across 27 observational studies indexed under Clubfoot.
Browse Clubfoot studies →University of Aberdeen is the lead sponsor of 176 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 to MRI scanning.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Neonates affected by clubfoot (n=10)
Other: Magnetic Resonance Imaging (MRI) of calf and foot
Control group of unaffected neonates (n=10)
Other: Magnetic Resonance Imaging (MRI) of calf and foot
Young adults having completed treatment (n=5)
Other: Magnetic Resonance Imaging (MRI) of calf and foot
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.
Also known as: MR scan
The record gives a start of May 2010, a primary completion of May 2011 and a completion of May 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.