Phenotyping the Alignment of the Lower Limb

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

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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Deformity
• Intervention / Treatment: Diagnostic test: EOS

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7632
      • Ádám Schlégl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Young, healthy volunteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pecs
• Investigators: Principal Investigator: Adam T Schlegl, M.D., Ph.D., University of Pecs Medical School, Department of Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: EOS 2D/3D; Osteoarthritis of the Knee; Lower limb alignment; Lower limb rotation; Osteoarthritis of the Hip
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: UP-CC-Ortho-LLimbAlign

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If the approval of the participants make it possible, the whole dataset will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No