NCT05108116

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

October 12, 2021

Last Update Submit

March 21, 2023

Conditions

Lower Limb Deformity

Keywords

EOS 2D/3DLower limb alignmentLower limb rotationOsteoarthritis of the KneeOsteoarthritis of the Hip

Outcome Measures

Primary Outcomes (15)

  • 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

Study Arms (1)

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

Interventions

EOSDIAGNOSTIC_TEST

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

Also known as: EOS 2D/3D scanning and SterEOS 3D reconstruction
Study group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young, healthy volunteers

You may qualify if:

  • Age: 18-30 years
  • BMI: \< 30
  • Without orthopaedic complaint

You may not qualify if:

  • Previous surgery on lower limb or spine
  • Developmental disorder in the patients history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ádám Schlégl

Pécs, Baranya, 7632, Hungary

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Adam T Schlegl, M.D., Ph.D.

    University of Pecs Medical School, Department of Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

November 4, 2021

Study Start

October 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations

HU(1)