Skip to main content
OpenTrials
Completed

NCT Number: NCT05108116

Phenotyping the Alignment of the Lower Limb

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ádám Schlégl

Pécs, Baranya, 7632, Hungary

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOS

Diagnostic Test

EOS Micro Dose imaging will be done. SterEOS 3D recontruction of the lower limb and pelvis will be performed.

Other names: EOS 2D/3D scanning and SterEOS 3D reconstruction

Primary outcomes

  1. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  2. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  3. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  4. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    Based on the stereo radiographs, SterEOS 3D reconstruction will be done. The SterEOS software calculates automatically 15 parameters including:

    • Femoral head diameter - mm
  5. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  7. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  8. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  9. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  10. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  11. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  12. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  13. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  14. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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
  15. 3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 4, 2021
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.