Limb DeformitiesMI3DEOSNCT02566954
3 Dimensional Study of Lower Limbs and Feet of Children in Standing Position
A study testing 3D measurement of the lower limb by EOS in people with Limb Deformities, run by Fondation Lenval at 2 sites in France.
Trial summary
The study will be in 3 parts: first one will be to address the key question of the lower limb frontal alignment based on both three-dimensional measurements of low-dose bi-planar X-rays and foot morphology assessment. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Limb Deformities
- What is being tested?
- 3D measurement of the lower limb by EOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesFrance
- Study dates
- 25 May 2014to 20 May 2016
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients between 6 and 18 years, feminine and male. -Preliminary clinical examination - Statigramme by the system EOS ® (pond shin thighbone foot) prescribes within the framework of a surveillance of any pathology not interfering with the data to be studied
- Patients capable of standing without moving and without help the time of the acquisition EOS ®, approximately 30 seconds.
- Consent of the patient and the legal representative
- Membership in a national insurance scheme
Who cannot join
- Child before 6 years or after 18 years
- Incapacitated to stand(to hold water) without support(medium) and without moving during 30 seconds (time(weather) of acquisition Of the image)
- History of pathology or surgical gesture(movement) on lower limbs which can modify Frontal bone or the twistings of lower limbs morphotype.
- Refusal of the legal representative or the patient.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Fondation Lenval
Nice, 06200
Hôpital Necker enfants Malades
Paris, 75015
About this study
The study will be in 3 parts: first one will be to address the key question of the lower limb frontal alignment based on both three-dimensional measurements of low-dose bi-planar X-rays and foot morphology assessment. Indeed, a major issue in the management of lower limb disorders is the ability to correctly assess abnormal development and decide on the most adapted treatment option. In particular, the link between lower limb disorders and foot morphology remain unclear. Recently, quantitative 3D measurement of the lower limb in children has been successfully assessed using low-dose biplanar X-rays.
Second part will be to assess the reproducibility of the 3dimensional reconstructions whether they are made by a radiology technician, or by a so-called expert through collecting datas from 3 centers of pediatric surgery where EOS Imaging system is daily used to get spine or lower limb X-Rays.
Last part will be to work on the recently developed weight-bearing foot 3D reconstruction method for clinical use using the Parametric Personalized Modelling approach (PPM). This will allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.
Read the detailed description
The study will be in 3 parts:
First one will be to address the key question of the lower limb frontal alignment based on both three-dimensional measurements of low-dose bi-planar X-rays and foot morphology assessment. Indeed, a major issue in the management of lower limb disorders is the ability to correctly assess abnormal development and decide on the most adapted treatment option. In particular, the link between lower limb disorders and foot morphology remain unclear. Recently, quantitative 3D measurement of the lower limb in children has been successfully assessed using low-dose biplanar X-rays. The population studied will be 133 patients, aged 6 to 16 years old, for whom a lower limb standing X-ray is required for a medical reason not interfering with torsional or longitudinal axis of the limb (such as, for example, patients consulting for non-specific lower limb pain). All patients will have low-dose biplanar X-rays using the EOS® system (EOS® Imaging, France). From the EOS® bi-planar images, a 3D patient-specific parametric model of the lower limbs will be obtained. The clinical indices (i.e. mechanical femoral (MFA) and mechanical tibial (MTA) angles, Hip Knee Shaft angle (HKS) and femoro tibial angle (FTA)) will then be automatically computed. For each clinical parameter, the mean value and standard deviation will be calculated, depending on the age group, gender, and on foot morphology
Second part is to assess the reproducibility of the 3dimensional reconstructions whether they are made by a radiology technician, or by a so-called expert through collecting datas from 3 centers of pediatric surgery where EOS Imaging system is daily used to get spine or lower limb X-Rays. The investigators will include 20 children, divided as follow: six typically developing ones (control X-Rays or lower limb standing X-ray required for a medical reason not interfering with torsional or longitudinal axis of the limb), 6 non-typically developing (by example children who underwent a lower limb fracture), 6 cerebral palsy ones, and 2 children with extreme lower limb deformities. Reconstructions will be done twice in each center: once by a qualified operator, senior orthopedic surgeon, who followed a practical course, and once by a radiology technician, also used to the software.
First step will be to calculate the reproducibility for all parameters, depending on each subgroup of patient. Then, for each parameter, outliers' values will be analyzed and explained. They will be then suppressed from the datas to re-calculate the reproducibility. Finally, reproducibility of the obtained parameters will be compared to the one published in literature
Last part will be to work on the recently developed weight-bearing foot 3D reconstruction method for clinical use using the Parametric Personalized Modelling approach (PPM). This will allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.
- Conditions
- Limb Deformities
- Being tested
- 3D measurement of the lower limb by EOS
- Keywords
- radiology, 3D measurement, lower limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D measurement of the lower limb by EOSOther
The intervention is to performed an additional radiologic exam by the EOS® system of imaging. This imaging is not usually realized for the patient.
3 dimensional study of lower limbs and feet of children in standing position will be performed using the EOS® system (EOS® Imaging, France)
| Study group | Role | What they receive |
|---|---|---|
| 3D measurement of the lower limb by EOS | Experimental | The intervention is to performed an additional radiologic exam by the EOS® system of imaging. This imaging is not usually realized for the patient.
3 dimensional study of lower limbs and feet of children in standing position will be performed using the EOS® system (EOS® Imaging, France) Receives: Other: 3D measurement of the lower limb by EOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D reconstruction of the angle of the lower limb
The modelling in 3 D lower limbs will be made from the following measures on the acquisitions of lower limbs:
*In the frontal plan (face) mechanical angles:
Angle LPFA: side femoral proximal angle: 90 ° (85-95 °) mLDFA angle: side mechanical femoral distal angle 87 ° (85-90 °) angle MPTA: medial proximal tibial angle: 87 ° (85-90 °) angle LDTA: side distal tibial angle: 89 ° (86-92 °) anatomical angles:
Angle HKA: center of the femoral head centers of the knee center of the ankle: 176-180 ° angle MPFA: femoral medial proximal angle: 84 ° (80-89 °) aLDFA angle: side anatomical femoral distal angle: 81 ° (79-83 °) angle MPTA: medial proximal tibial angle: 87 ° (85-90 °) angle LDTA: side distal tibial angle: 89 ° (86-92 °) *In the saggital plan (profile): Angle PDFA: femoral posterior distal angle: 83 ° (79-87 °) angle PPTA: posterior proximal tibial angle: 81 ° (77-84 °) angle ADTA: anterior distal tibial angle: 80 ° (78-82 °)
*In the horizontal plan: Femoral twisting 7-24 °
Measured: At baseline during the visit of inclusion
Secondary outcomes (2)
3D reconstruction of the angle of lower limbs according to age group
To study the model in 3D of lower limbs according to age group (6-9 years; 10-12 years; 13-15 years; 16-18 years)
The modelling will be made from the following measures :
*In the frontal plan mechanical angles:
Angle LPFA: side femoral proximal angle: 90 ° (85-95 °), side mechanical femoral distal angle 87 ° (85-90 °), angle medial proximal tibial angle: 87 ° (85-90 °), side distal tibial angle: 89 ° (86-92 °) anatomical angles:
Center of the femoral head centers of the knee center of the ankle: 176-180 ° angle femoral medial proximal angle: 84 ° (80-89 °), side anatomical femoral distal angle: 81 ° (79-83 °) angle medial proximal tibial angle: 87 ° (85-90 °), side distal tibial angle: 89 ° (86-92 °) *In the saggital plan (profile): Angle femoral posterior distal angle: 83 ° (79-87 °) angle posterior proximal tibial angle: 81 ° (77-84 °) angle anterior distal tibial angle: 80 ° (78-82 °)
*In the horizontal plan: Femoral twisting 7-24 °
Measured: At baseline during the visit of inclusion
Valuable elaboration in 3 dimensions of the angle to characterize the various groups of feet
Valuable elaboration in 3 dimensions(size) to characterize the various groups of feet by measuring on the reconstructions obtained from the following already known angles:
Picture dorso plantar:
talocalcaneal difference: longitudinal axis bank and calcaneus 15-25 °. Talus Angle - 1st metatarsal: 0 10 °. Angle calcaneus - 5th metatarsal: 0 °. talo navicular cover Angle : median longitudinal axis of the bank and perpendicular in the frontal axis of the naviculaire.
Cuneo angle-M1: perpendicular in the edge medial of the medial cuneiform and space cm M1: 10-20 °.
Report column medial (calca médial + M1) / side column (calca side + M5): Men: 26, Women: 34 (between 5 and 17 years).
Measured: At baseline during the visit of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start25 May 2014
- Primary completion20 May 2016
- Study completion20 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb DeformitiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie RAMPAL, MD, Principal investigator, Fondation Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566954
- Sponsor's protocol ID
- 14-HPNCL-03
- Acronym
- MI3DEOS
- Status last verified
- Jul 2018
- First submitted
- 22 Jul 2015
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3 Dimensional Study of Lower Limbs and Feet of Children in Standing Position
- ClinicalTrials.gov ID
- NCT02566954
- Acronym / sponsor ID
- MI3DEOS / 14-HPNCL-03
- Conditions
- Limb Deformities
- Keywords
- radiology, 3D measurement, lower limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 25 May 2014 (actual)
- Primary completion
- 20 May 2016 (actual)
- Study completion
- 20 May 2016 (actual)
- First posted
- 2 Oct 2015 (estimated)
- 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.
The study will be in 3 parts: first one will be to address the key question of the lower limb frontal alignment based on both three-dimensional measurements of low-dose bi-planar X-rays and foot morphology assessment. Indeed, a major issue in the management of lower limb disorders is the ability to correctly assess abnormal development and decide on the most adapted treatment option. In particular, the link between lower limb disorders and foot morphology remain unclear. Recently, quantitative 3D measurement of the lower limb in children has been successfully assessed using low-dose biplanar X-rays.
Second part will be to assess the reproducibility of the 3dimensional reconstructions whether they are made by a radiology technician, or by a so-called expert through collecting datas from 3 centers of pediatric surgery where EOS Imaging system is daily used to get spine or lower limb X-Rays.
Last part will be to work on the recently developed weight-bearing foot 3D reconstruction method for clinical use using the Parametric Personalized Modelling approach (PPM). This will allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.
Detailed description
The study will be in 3 parts:
First one will be to address the key question of the lower limb frontal alignment based on both three-dimensional measurements of low-dose bi-planar X-rays and foot morphology assessment. Indeed, a major issue in the management of lower limb disorders is the ability to correctly assess abnormal development and decide on the most adapted treatment option. In particular, the link between lower limb disorders and foot morphology remain unclear. Recently, quantitative 3D measurement of the lower limb in children has been successfully assessed using low-dose biplanar X-rays. The population studied will be 133 patients, aged 6 to 16 years old, for whom a lower limb standing X-ray is required for a medical reason not interfering with torsional or longitudinal axis of the limb (such as, for example, patients consulting for non-specific lower limb pain). All patients will have low-dose biplanar X-rays using the EOS® system (EOS® Imaging, France). From the EOS® bi-planar images, a 3D patient-specific parametric model of the lower limbs will be obtained. The clinical indices (i.e. mechanical femoral (MFA) and mechanical tibial (MTA) angles, Hip Knee Shaft angle (HKS) and femoro tibial angle (FTA)) will then be automatically computed. For each clinical parameter, the mean value and standard deviation will be calculated, depending on the age group, gender, and on foot morphology
Second part is to assess the reproducibility of the 3dimensional reconstructions whether they are made by a radiology technician, or by a so-called expert through collecting datas from 3 centers of pediatric surgery where EOS Imaging system is daily used to get spine or lower limb X-Rays. The investigators will include 20 children, divided as follow: six typically developing ones (control X-Rays or lower limb standing X-ray required for a medical reason not interfering with torsional or longitudinal axis of the limb), 6 non-typically developing (by example children who underwent a lower limb fracture), 6 cerebral palsy ones, and 2 children with extreme lower limb deformities. Reconstructions will be done twice in each center: once by a qualified operator, senior orthopedic surgeon, who followed a practical course, and once by a radiology technician, also used to the software.
First step will be to calculate the reproducibility for all parameters, depending on each subgroup of patient. Then, for each parameter, outliers' values will be analyzed and explained. They will be then suppressed from the datas to re-calculate the reproducibility. Finally, reproducibility of the obtained parameters will be compared to the one published in literature
Last part will be to work on the recently developed weight-bearing foot 3D reconstruction method for clinical use using the Parametric Personalized Modelling approach (PPM). This will allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D measurement of the lower limb by EOS | Experimental | Other: 3D measurement of the lower limb by EOSThe intervention is to performed an additional radiologic exam by the EOS® system of imaging. This imaging is not usually realized for the patient. 3 dimensional study of lower limbs and feet of children in standing position will be performed using the EOS® system (EOS® Imaging, France) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients between 6 and 18 years, feminine and male. -Preliminary clinical examination - Statigramme by the system EOS ® (pond shin thighbone foot) prescribes within the framework of a surveillance of any pathology not interfering with the data to be studied
- Patients capable of standing without moving and without help the time of the acquisition EOS ®, approximately 30 seconds.
- Consent of the patient and the legal representative
- Membership in a national insurance scheme
Key exclusion criteria (4 listed)
- Child before 6 years or after 18 years
- Incapacitated to stand(to hold water) without support(medium) and without moving during 30 seconds (time(weather) of acquisition Of the image)
- History of pathology or surgical gesture(movement) on lower limbs which can modify Frontal bone or the twistings of lower limbs morphotype.
- Refusal of the legal representative or the patient.
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 |
|---|---|---|
| 3D measurement of the lower limb by EOSThe intervention is to performed an additional radiologic exam by the EOS® system of imaging. This imaging is not usually realized for the patient. 3 dimensional study of lower limbs and feet of children in standing position will be performed using the EOS® system (EOS® Imaging, France) | Other | 3D measurement of the lower limb by EOS |
Primary outcome
3D reconstruction of the angle of the lower limb
Time frame: At baseline during the visit of inclusion
The modelling in 3 D lower limbs will be made from the following measures on the acquisitions of lower limbs: *In the frontal plan (face) mechanical angles: Angle LPFA: side femoral proximal angle: 90 ° (85-95 °) mLDFA angle: side mechanical femoral distal angle 87 ° (85-90 °) angle MPTA: medial proximal tibial angle: 87 ° (85-90 °) angle LDTA: side distal tibial angle: 89 ° (86-92 °) anatomical angles: Angle HKA: center of the femoral head centers of the knee center of the ankle: 176-180 ° angle MPFA: femoral medial proximal angle: 84 ° (80-89 °) aLDFA angle: side anatomical femoral distal angle: 81 ° (79-83 °) angle MPTA: medial proximal tibial angle: 87 ° (85-90 °) angle LDTA: side distal tibial angle: 89 ° (86-92 °) *In the saggital plan (profile): Angle PDFA: femoral posterior distal angle: 83 ° (79-87 °) angle PPTA: posterior proximal tibial angle: 81 ° (77-84 °) angle ADTA: anterior distal tibial angle: 80 ° (78-82 °) *In the horizontal plan: Femoral twisting 7-24 °
2 secondary outcomes
3D reconstruction of the angle of lower limbs according to age group
Time frame: At baseline during the visit of inclusion
Valuable elaboration in 3 dimensions of the angle to characterize the various groups of feet
Time frame: At baseline during the visit of inclusion
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 30 Jul 2018.
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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.
Virginie RAMPAL, MD principal investigator
Fondation Lenval
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D measurement of the lower limb by EOS in people with Limb Deformities, run by Fondation Lenval at 2 sites in France.
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 4 inclusion and 4 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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 of the angle of the lower limb (time frame: At baseline during the visit of inclusion). 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 30 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.