Idiopathic ScoliosisEOSTransfertNCT03209752
Prediction of 3D Effect of Brace in Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
An observational study of Idiopathic Scoliosis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
In this study, the accuracy of a new numerical method is evaluated for predicting the 3D effect of brace on idiopathic scoliosis. This method results from the combination of several innovative technologies: the EOS imaging system and the anatomical transfer developed by Anatoscope. Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Idiopathic Scoliosis
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Sep 2018
- 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 9 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children or adolescent idiopathic scoliosis patient
Who may be able to join
- patients aged 9 to 15 years;
- with idiopathic scoliosis (left lumbar and / or right chest);
- with moderate scoliosis: Cobb angle evaluated between 15 ° and 35 °;
- requiring brace placement or renewal;
- having signed a non-objection form
- affiliated with, or receiving, social security
Who cannot join
- patient/parents who refuse to sign a non-objectiont form
- with unstable medical condition
- person deprived of liberty by judicial or administrative decision
- person under legal protection or unable to express their consent
- person hospitalized for psychiatric care
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric Orthopedic Department, University Hospital, Grenoble
Grenoble, 38043
About this study
Official title: Prediction of 3D Effect of Brace in Adolescent and Children Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
In this study, the accuracy of a new numerical method is evaluated for predicting the 3D effect of brace on idiopathic scoliosis. This method results from the combination of several innovative technologies: the EOS imaging system and the anatomical transfer developed by Anatoscope. This is an essential step in validating a digital tool that can be used in routine clinical practice.
Read the detailed description
The whole process of brace production remains unchanged. In this study, the simulation software will not be used to influence the medical decision or the manufacture of the brace. In parallel with conventional production, anatomical transfer will be used in the deformed digital model of the trunk to simulate the effect of conventional brace on the spine. This modeling will be used to compare the correction of the conventional brace observed on the spine with EOS imaging system, with that simulated by the software.
EOS Tranfert study is a observationnal, prospective, monocentric, unrandomized and controlled study. This research doesn't modify care of the patient
- Conditions
- Idiopathic Scoliosis
- Keywords
- 3D analysis, Brace, EOS imagind system, Anatomical transfer
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the frontal plane.
Difference measurement in degrees between the digital Cobb angle after simulation and the actual Cobb angle under brace after EOS radiography.
Measured: 12 month
Secondary outcomes (4)
Evaluation of the accuracy of the brace effect by the new anatomical transfer method on the spinal axial rotation.
Difference measurement in degrees between apical axial vertebral rotation angle (AVR) after simulation and the actual AVR under brace after EOS radiography.
Measured: 12 month
Evaluation of the accuracy of brace effect by the new anatomical transfer method on the torsion index.
Difference measurement in degrees between the numerical torsion index after simulation and the actual torsion index under brace after EOS radiography.
Measured: 12 month
Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the sagittal plane
Difference measurement in degrees between kyphosis angle, digital lordosis after simulation and kyphosis angle, real lordosis under brace after EOS radiography.
Measured: 12 month
Evaluation of the accuracy of ribs position of the patient under 3D digital model of brace with respect to the actual position under brace
Point-to-point distance between the average rib line after simulation and under brace after EOS radiography
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study startMay 2016
- Primary completionMay 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Demeure Orthopédie, Anatoscope, Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Courvoisier Aurélien, MD, PhD, Principal investigator, Pediatric Orthopedic department, University GrenobleHospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209752
- Sponsor's protocol ID
- DCIC15-01
- Acronym
- EOSTransfert
- Status last verified
- Sep 2018
- First submitted
- 3 Jul 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of 3D Effect of Brace in Adolescent and Children Idiopathic Scoliosis Treatment Using EOS Imaging System and "Anatomic Transfer".
- ClinicalTrials.gov ID
- NCT03209752
- Acronym / sponsor ID
- EOSTransfert / DCIC15-01
- Conditions
- Idiopathic Scoliosis
- Keywords
- 3D analysis, Brace, EOS imagind system, Anatomical transfer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Demeure Orthopédie, Anatoscope, Clinical Investigation Centre for Innovative Technology Network
- Study start
- May 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 6 Jul 2017 (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 this study, the accuracy of a new numerical method is evaluated for predicting the 3D effect of brace on idiopathic scoliosis. This method results from the combination of several innovative technologies: the EOS imaging system and the anatomical transfer developed by Anatoscope. This is an essential step in validating a digital tool that can be used in routine clinical practice.
Detailed description
The whole process of brace production remains unchanged. In this study, the simulation software will not be used to influence the medical decision or the manufacture of the brace. In parallel with conventional production, anatomical transfer will be used in the deformed digital model of the trunk to simulate the effect of conventional brace on the spine. This modeling will be used to compare the correction of the conventional brace observed on the spine with EOS imaging system, with that simulated by the software.
EOS Tranfert study is a observationnal, prospective, monocentric, unrandomized and controlled study. This research doesn't modify care of the patient
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children or adolescent idiopathic scoliosis patient
Key inclusion criteria (6 listed)
- patients aged 9 to 15 years;
- with idiopathic scoliosis (left lumbar and / or right chest);
- with moderate scoliosis: Cobb angle evaluated between 15 ° and 35 °;
- requiring brace placement or renewal;
- having signed a non-objection form
Key exclusion criteria (5 listed)
- patient/parents who refuse to sign a non-objectiont form
- with unstable medical condition
- person deprived of liberty by judicial or administrative decision
- person under legal protection or unable to express their consent
- person hospitalized for psychiatric care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the frontal plane.
Time frame: 12 month
Difference measurement in degrees between the digital Cobb angle after simulation and the actual Cobb angle under brace after EOS radiography.
4 secondary outcomes
Evaluation of the accuracy of the brace effect by the new anatomical transfer method on the spinal axial rotation.
Time frame: 12 month
Evaluation of the accuracy of brace effect by the new anatomical transfer method on the torsion index.
Time frame: 12 month
Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the sagittal plane
Time frame: 12 month
Evaluation of the accuracy of ribs position of the patient under 3D digital model of brace with respect to the actual position under brace
Time frame: 12 month
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 10 Sep 2018.
- Clinical Investigation Centre for Innovative Technology Network websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Courvoisier Aurélien, MD, PhD principal investigator
Pediatric Orthopedic department, University GrenobleHospital
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 Idiopathic Scoliosis, run by University Hospital, Grenoble at 1 site 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 6 inclusion and 5 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 10 Sep 2018. 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 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?
Evaluation of the accuracy of the brace effect by the new anatomical transfer method in the frontal plane. (time frame: 12 month). 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 10 Sep 2018.