Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI

NCT01088828 | Completed DMC

• 1 other identifier: MRC/BM056
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 1.compare structural variations observed in the calf and foot of the clubfoot mouse model(pma)with human clubfoot patients antenatally and postnatally;
2. 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.

Conditions

Clubfoot

Keywords

MRI, clubfoot, CTEV, Congenital Talipes Equinovarus

Study Arms (5)

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

Group B

Neonates affected by clubfoot (n=10)

Other: Magnetic Resonance Imaging (MRI) of calf and foot

Group C

Control group of unaffected neonates (n=10)

Other: Magnetic Resonance Imaging (MRI) of calf and foot

Group D

Young adults having completed treatment (n=5)

Other: Magnetic Resonance Imaging (MRI) of calf and foot

Group E

Control group of young unaffected adults (n=5)

Other: Magnetic Resonance Imaging (MRI) of calf and foot

Interventions

Magnetic Resonance Imaging (MRI) of calf and foot OTHER

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

Group A; Group B; Group C; Group D; Group E

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

University of Aberdeen

Aberdeen, AB24 3FX, United Kingdom

Location

MeSH Terms

Conditions

Clubfoot

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Zosia H Miedzybrodzka, MBChB, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

• Simon L Barker, FRCS, MD

  NHS Grampian Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 5, 2015

Record last verified: 2015-11

Locations

GB (1)