Limb Deformities Clinical Trial
Official title:
3 Dimensional Study of Lower Limbs and Feet of Children in Standing Position
The study will be in 3 parts: first one will be to address the key question of the lower limb
frontal alignment based on both three-dimensional measurements of low-dose bi-planar X-rays
and foot morphology assessment. Indeed, a major issue in the management of lower limb
disorders is the ability to correctly assess abnormal development and decide on the most
adapted treatment option. In particular, the link between lower limb disorders and foot
morphology remain unclear. Recently, quantitative 3D measurement of the lower limb in
children has been successfully assessed using low-dose biplanar X-rays.
Second part will be to assess the reproducibility of the 3dimensional reconstructions whether
they are made by a radiology technician, or by a so-called expert through collecting datas
from 3 centers of pediatric surgery where EOS Imaging system is daily used to get spine or
lower limb X-Rays.
Last part will be to work on the recently developed weight-bearing foot 3D reconstruction
method for clinical use using the Parametric Personalized Modelling approach (PPM). This will
allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.
The study will be in 3 parts:
First one will be to address the key question of the lower limb frontal alignment based on
both three-dimensional measurements of low-dose bi-planar X-rays and foot morphology
assessment. Indeed, a major issue in the management of lower limb disorders is the ability to
correctly assess abnormal development and decide on the most adapted treatment option. In
particular, the link between lower limb disorders and foot morphology remain unclear.
Recently, quantitative 3D measurement of the lower limb in children has been successfully
assessed using low-dose biplanar X-rays. The population studied will be 133 patients, aged 6
to 16 years old, for whom a lower limb standing X-ray is required for a medical reason not
interfering with torsional or longitudinal axis of the limb (such as, for example, patients
consulting for non-specific lower limb pain). All patients will have low-dose biplanar X-rays
using the EOS® system (EOS® Imaging, France). From the EOS® bi-planar images, a 3D
patient-specific parametric model of the lower limbs will be obtained. The clinical indices
(i.e. mechanical femoral (MFA) and mechanical tibial (MTA) angles, Hip Knee Shaft angle (HKS)
and femoro tibial angle (FTA)) will then be automatically computed. For each clinical
parameter, the mean value and standard deviation will be calculated, depending on the age
group, gender, and on foot morphology
Second part is to assess the reproducibility of the 3dimensional reconstructions whether they
are made by a radiology technician, or by a so-called expert through collecting datas from 3
centers of pediatric surgery where EOS Imaging system is daily used to get spine or lower
limb X-Rays. The investigators will include 20 children, divided as follow: six typically
developing ones (control X-Rays or lower limb standing X-ray required for a medical reason
not interfering with torsional or longitudinal axis of the limb), 6 non-typically developing
(by example children who underwent a lower limb fracture), 6 cerebral palsy ones, and 2
children with extreme lower limb deformities. Reconstructions will be done twice in each
center: once by a qualified operator, senior orthopedic surgeon, who followed a practical
course, and once by a radiology technician, also used to the software.
First step will be to calculate the reproducibility for all parameters, depending on each
subgroup of patient. Then, for each parameter, outliers' values will be analyzed and
explained. They will be then suppressed from the datas to re-calculate the reproducibility.
Finally, reproducibility of the obtained parameters will be compared to the one published in
literature
Last part will be to work on the recently developed weight-bearing foot 3D reconstruction
method for clinical use using the Parametric Personalized Modelling approach (PPM). This will
allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.
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