Phenotyping the Alignment of the Lower Limb

Study Overview
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Brief Summary
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In the international literature there are only few publication about the normal biomechanical parameters of the lower limb examined prospectively in healthy population. The goal of our study to determine 15 anatomical and biomechanical parameters of the lower limb using 3D reconstruction based on upright, stereo radiographs in young, healthy volunteers.

Official Title
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Phenotyping the Alignment and Rotational Parameters of the Lower Limb in Young Non-osteoarthritic Population

Conditions
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Lower Limb Deformity

Intervention / Treatment
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* Diagnostic Test: EOS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-30 years BMI: < 30 Without orthopaedic complaint Exclusion Criteria: Previous surgery on lower limb or spine Developmental disorder in the patients history

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>18-30 year-old, healthy volunteers Age: 18-30 years BMI: <30 No previous surgery on lower limb or spine No known developmental disorder Without any orthopaedic complaint | Diagnostic Test: EOS<br>* EOS Micro Dose imaging will be done. SterEOS 3D recontruction of the lower limb and pelvis will be performed.<br>* Other names: EOS 2D/3D scanning and SterEOS 3D reconstruction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Length of the femoral mechanical axis (femur length) - mm | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters, including: • Length of the tibial mechanical axis (tibia length) - mm | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • The length of the lower limb (limb length) - mm | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Femoral head diameter - mm | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Neck length (the distance between the centre of the femoral head and the proximal diaphyseal axis, when following the axis of the femoral neck) - mm | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Neck shaft angle, aka the collodiaphyseal angle (CD angle, the angle between the femoral neck axis and the proximal diaphysis axis) - degrees | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Femoral offset (the distance between the centre of the femoral head and the closest point of the femoral shaft axis) - mm | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Mechanical tibiofemoral angle (mTFA, the angle between the mechanical axis of the femur (which passes from the femoral head through the centre of the distal femur) and the mechanical axis of the tibia (from the centre of the proximal tibia to the middle of the ankle) in the frontal plane of knee (convention dictates that in the varus position angles are negative, and in valgus positive) - degrees | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Sagittal tibiofemoral angle (sTFA, the angle between the femural and tibial mechanical axis in the sagittal plane) - degrees | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Femoral mechanical axis-femoral shaft angle (FM-FS, the angle between the mechanical and anatomical axis of the femur in the frontal plane of the knee) - degrees | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Femur mechanical angle (FMA, the angle between the femoral mechanical axis and the tangent of the femoral condyles medially) - degrees | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Tibial mechanical angle (TMA, the angle between tibial mechanical axis and the tangent of the tibia plateau medially) - degrees | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Femoral torsion (the angle between the femoral neck axis and the posterior condylar line projected on a plane perpendicular to the mechanical axis of the femur) - degrees | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Tibial torsion (the angle between the transmalleolar and transcondylar axis projected on a plane perpendicular to the mechanical axis of the tibia) - degrees | 6 months | 
| 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb | Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including: • Femorotibial rotation (the angle between the posterior condylar line of the femur and tibia) - degrees | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EOS 2D/3D, Lower limb alignment, Lower limb rotation, Osteoarthritis of the Knee, Osteoarthritis of the Hip