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临床试验/NCT02566954
NCT02566954已完成不适用

3 Dimensional Study of Lower Limbs and Feet of Children in Standing Position

Fondation Lenval2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2014年5月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
2
主要终点
3D reconstruction of the angle of the lower limb

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients between 6 and 18 years, feminine and male. -Preliminary clinical examination - Statigramme by the system EOS ® (pond shin thighbone foot) prescribes within the framework of a surveillance of any pathology not interfering with the data to be studied
  • •Patients capable of standing without moving and without help the time of the acquisition EOS ®, approximately 30 seconds.
  • •Consent of the patient and the legal representative
  • •Membership in a national insurance scheme

排除标准

  • •Child before 6 years or after 18 years
  • •Incapacitated to stand(to hold water) without support(medium) and without moving during 30 seconds (time(weather) of acquisition Of the image)
  • •History of pathology or surgical gesture(movement) on lower limbs which can modify Frontal bone or the twistings of lower limbs morphotype.
  • •Refusal of the legal representative or the patient.

研究组 & 干预措施

3D measurement of the lower limb by EOS

Experimental

The intervention is to performed an additional radiologic exam by the EOS® system of imaging. This imaging is not usually realized for the patient.

3 dimensional study of lower limbs and feet of children in standing position will be performed using the EOS® system (EOS® Imaging, France)

干预措施: 3D measurement of the lower limb by EOS (Other)

结局指标

主要结局

3D reconstruction of the angle of the lower limb

时间窗: At baseline during the visit of inclusion

The modelling in 3 D lower limbs will be made from the following measures on the acquisitions of lower limbs: \*In the frontal plan (face) mechanical angles: Angle LPFA: side femoral proximal angle: 90 ° (85-95 °) mLDFA angle: side mechanical femoral distal angle 87 ° (85-90 °) angle MPTA: medial proximal tibial angle: 87 ° (85-90 °) angle LDTA: side distal tibial angle: 89 ° (86-92 °) anatomical angles: Angle HKA: center of the femoral head centers of the knee center of the ankle: 176-180 ° angle MPFA: femoral medial proximal angle: 84 ° (80-89 °) aLDFA angle: side anatomical femoral distal angle: 81 ° (79-83 °) angle MPTA: medial proximal tibial angle: 87 ° (85-90 °) angle LDTA: side distal tibial angle: 89 ° (86-92 °) \*In the saggital plan (profile): Angle PDFA: femoral posterior distal angle: 83 ° (79-87 °) angle PPTA: posterior proximal tibial angle: 81 ° (77-84 °) angle ADTA: anterior distal tibial angle: 80 ° (78-82 °) \*In the horizontal plan: Femoral twisting 7-24 °

次要结局

  • 3D reconstruction of the angle of lower limbs according to age group(At baseline during the visit of inclusion)
  • Valuable elaboration in 3 dimensions of the angle to characterize the various groups of feet(At baseline during the visit of inclusion)

研究者

发起方
Fondation Lenval
申办方类型
Other
责任方
Sponsor

研究点 (2)

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