Phenotyping the Alignment of the Lower Limb

Lower Limb Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05108116
• Other study ID #: UP-CC-Ortho-LLimbAlign
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Lower Limb Deformity

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