Lower Limb DeformityNCT05108116
Phenotyping the Alignment of the Lower Limb
An observational study of Lower Limb Deformity, run by University of Pecs at 1 site in Hungary.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Deformity
- What is being tested?
- EOS
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 1 Oct 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young, healthy volunteers
Who may be able to join
- Age: 18-30 years
- BMI: < 30
- Without orthopaedic complaint
Who cannot join
- Previous surgery on lower limb or spine
- Developmental disorder in the patients history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lower Limb Deformity
- Being tested
- EOS
- Keywords
- EOS 2D/3D, Lower limb alignment, Lower limb rotation, Osteoarthritis of the Knee, Osteoarthritis of the Hip
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOSDiagnostic test
Also called EOS 2D/3D scanning and SterEOS 3D reconstruction
EOS Micro Dose imaging will be done. SterEOS 3D recontruction of the lower limb and pelvis will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: EOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam T Schlegl, M.D., Ph.D., Principal investigator, University of Pecs Medical School, Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108116
- Sponsor's protocol ID
- UP-CC-Ortho-LLimbAlign
- Status last verified
- Mar 2023
- First submitted
- 12 Oct 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If the approval of the participants make it possible, the whole dataset will be published.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping the Alignment and Rotational Parameters of the Lower Limb in Young Non-osteoarthritic Population
- ClinicalTrials.gov ID
- NCT05108116
- Acronym / sponsor ID
- UP-CC-Ortho-LLimbAlign
- Conditions
- Lower Limb Deformity
- Keywords
- EOS 2D/3D, Lower limb alignment, Lower limb rotation, Osteoarthritis of the Knee, Osteoarthritis of the Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: EOS18-30 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young, healthy volunteers
Key inclusion criteria (3 listed)
- Age: 18-30 years
- BMI: < 30
- Without orthopaedic complaint
Key exclusion criteria (2 listed)
- Previous surgery on lower limb or spine
- Developmental disorder in the patients history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOSAlso: EOS 2D/3D scanning and SterEOS 3D reconstructionEOS Micro Dose imaging will be done. SterEOS 3D recontruction of the lower limb and pelvis will be performed. | Diagnostic test | Study group |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: Undecided. If the approval of the participants make it possible, the whole dataset will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam T Schlegl, M.D., Ph.D. principal investigator
University of Pecs Medical School, Department of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Deformity, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D reconstruction with 15 anatomical and biomechanical parameter of the lower limb (time frame: 6 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.