ScoliosisMODEL MAKERNCT01336114
A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace
An observational study of Scoliosis, run by Rennes University Hospital at 1 site in France.
Trial summary
Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the spine. In case of progressive curve deformity, the use of spinal bracing remains the standard non operative treatment of moderate AIS. Read more about this study
- Who is it for?
- Ages 12 to 15 years, women only
- Conditions the study is for
- Scoliosis
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to not given
- 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 12 to 15 years
- Women only
- No healthy volunteers
- Child
Study population: Patients with idiopathic scoliosis
Who may be able to join
- Age ≥ 12 years
- Pre menarchial for the girls
- Risser 0 et Risser 3 on X rays. Radiologic classification of spine maturity (ossification of the iliac crests). Five stages.
- Cobb angle ≥25° and < 40°
- Information to the parents and child, and signed approval
Who cannot join
- No idiopathic scoliosis
- Previous brace treatment
- Immediate indication for surgery
- Previous thoracic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the spine. In case of progressive curve deformity, the use of spinal bracing remains the standard non operative treatment of moderate AIS. Most of the time, the different types of braces don't take into account the individual biomechanical properties of each patient's spine. Actually, it is essential to better understand the effect of the loads applied on the trunk and on the spine, and a 3D geometrical modelisation of these components is essential. Many studies have been publishing concerning the use of radiographs for the geometrical reconstruction of the spine, and more recently the EOS system. But even then, it is still necessary to obtain an important number of geometrical data and discretisation is still a long procedure.
- Conditions
- Scoliosis
- Medical subject headings
- Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographs of the back and spine radiographs for making a corset
The torso shape reconstruction is realized thanks to the system Model Maker(Proteor®) on adolescent idiopathic patients. Model Maker allows to reconstruct the external shape of the human body from about 20 images steaming from a standard digital camera.The spine reconstruction is has for her obtained by means of a software interface, from tow standard clinical X-rays in the digital format (frontal and sagittal) and images were used by Model Maker for the external shape reconstruction.
Measured: 3 years
Secondary outcomes (1)
Recording of pressure from the brace
The recording of pressure from the brace is done through a web of pressure positioned in the brace. It is a structure "teck scan (Expert-Seat, Ergoresearch Inc)" containing polymeric pressure sensors. The pressure exerted by the brace on the trunk is registered in different positions (standing, lying).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- philippe violas, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336114
- Sponsor's protocol ID
- 2010-A01263-36
- Other IDs
- LOC/10-14
- Acronym
- MODEL MAKER
- Status last verified
- Nov 2014
- First submitted
- 6 Apr 2011
- Last updated
- 26 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace
- ClinicalTrials.gov ID
- NCT01336114
- Acronym / sponsor ID
- MODEL MAKER / 2010-A01263-36
- Conditions
- Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- First posted
- 15 Apr 2011 (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.
Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the spine. In case of progressive curve deformity, the use of spinal bracing remains the standard non operative treatment of moderate AIS. Most of the time, the different types of braces don't take into account the individual biomechanical properties of each patient's spine. Actually, it is essential to better understand the effect of the loads applied on the trunk and on the spine, and a 3D geometrical modelisation of these components is essential. Many studies have been publishing concerning the use of radiographs for the geometrical reconstruction of the spine, and more recently the EOS system. But even then, it is still necessary to obtain an important number of geometrical data and discretisation is still a long procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 15 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with idiopathic scoliosis
Key inclusion criteria (5 listed)
- Age ≥ 12 years
- Pre menarchial for the girls
- Risser 0 et Risser 3 on X rays. Radiologic classification of spine maturity (ossification of the iliac crests). Five stages.
- Cobb angle ≥25° and < 40°
- Information to the parents and child, and signed approval
Key exclusion criteria (4 listed)
- No idiopathic scoliosis
- Previous brace treatment
- Immediate indication for surgery
- Previous thoracic surgery
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
Photographs of the back and spine radiographs for making a corset
Time frame: 3 years
The torso shape reconstruction is realized thanks to the system Model Maker(Proteor®) on adolescent idiopathic patients. Model Maker allows to reconstruct the external shape of the human body from about 20 images steaming from a standard digital camera.The spine reconstruction is has for her obtained by means of a software interface, from tow standard clinical X-rays in the digital format (frontal and sagittal) and images were used by Model Maker for the external shape reconstruction.
1 secondary outcome
Recording of pressure from the brace
Time frame: 3 years
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 26 Nov 2014.
Related trials for Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
philippe violas principal investigator
Rennes University Hospital
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 Scoliosis, run by Rennes University Hospital 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 5 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 26 Nov 2014. 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?
Photographs of the back and spine radiographs for making a corset (time frame: 3 years). 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 26 Nov 2014.