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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05108116
Other study ID # UP-CC-Ortho-LLimbAlign
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date December 31, 2022

Study information

Verified date March 2023
Source University of Pecs
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Hungary Ádám Schlégl Pécs Baranya

Sponsors (1)

Lead Sponsor Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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