ClubfootNCT01088828
Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI
An observational study of Clubfoot, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Clubfoot
- What is being tested?
- Magnetic Resonance Imaging (MRI) of calf and foot
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- For all groups the exclusion criteria are any contraindication to MRI scanning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pma Mouse and the Developmental Basis of Clubfoot: MRI Anatomical Modelling of Human ICTEV (Clubfoot)
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.
Read the 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.
- Conditions
- Clubfoot
- Being tested
- Magnetic Resonance Imaging (MRI) of calf and foot
- Keywords
- MRI, clubfoot, CTEV, Congenital Talipes Equinovarus
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI) of calf and footOther
Also called MR scan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Magnetic Resonance Imaging (MRI) of calf and foot | |
| Group B | Neonates affected by clubfoot (n=10) Receives: Other: Magnetic Resonance Imaging (MRI) of calf and foot | |
| Group C | Control group of unaffected neonates (n=10) Receives: Other: Magnetic Resonance Imaging (MRI) of calf and foot | |
| Group D | Young adults having completed treatment (n=5) Receives: Other: Magnetic Resonance Imaging (MRI) of calf and foot | |
| Group E | Control group of young unaffected adults (n=5) Receives: Other: Magnetic Resonance Imaging (MRI) of calf and foot |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zosia H Miedzybrodzka, MBChB, PhD, Principal investigator, University of AberdeenSimon L Barker, FRCS, MD, Principal investigator, NHS Grampian Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088828
- Sponsor's protocol ID
- MRC/BM056
- Status last verified
- Nov 2015
- First submitted
- 16 Mar 2010
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pma Mouse and the Developmental Basis of Clubfoot: MRI Anatomical Modelling of Human ICTEV (Clubfoot)
- ClinicalTrials.gov ID
- NCT01088828
- Acronym / sponsor ID
- MRC/BM056
- Conditions
- Clubfoot
- Keywords
- MRI, clubfoot, CTEV, Congenital Talipes Equinovarus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Magnetic Resonance Imaging (MRI) of calf and footFoetuses 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. |
| Group B | – | Other: Magnetic Resonance Imaging (MRI) of calf and footNeonates affected by clubfoot (n=10) |
| Group C | – | Other: Magnetic Resonance Imaging (MRI) of calf and footControl group of unaffected neonates (n=10) |
| Group D | – | Other: Magnetic Resonance Imaging (MRI) of calf and footYoung adults having completed treatment (n=5) |
| Group E | – | Other: Magnetic Resonance Imaging (MRI) of calf and footControl group of young unaffected adults (n=5) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- For all groups the exclusion criteria are any contraindication to MRI scanning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI) of calf and footAlso: MR scanDetailed 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 | Group A, Group B, Group C, Group D, Group E |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zosia H Miedzybrodzka, MBChB, PhD principal investigator
University of Aberdeen
Simon L Barker, FRCS, MD principal investigator
NHS Grampian Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.