ScoliosisSCOBIOMODNCT02531945
Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
A study testing Use of Biomod device in people with Scoliosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The main objective of the study is to investigate the correlation between the measurement of the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface topography. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Use of Biomod device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to 31 May 2017
- 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 10 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient with idiopathic scoliosis,
- Body mass index BMI below or equal to 25,
- Cobb angle measured on radiographs between 10 and 25 degrees,
- Parental authorization.
Who cannot join
- Patient with secondary scoliosis (neurological, Prader Willi syndrome...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography
The main objective of the study is to investigate the correlation between the measurement of the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface topography.
The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L.
Read the detailed description
For usual follow-up visit, patients will have a x-ray examination of the spine and the surface topography. The measurement of the angle of scoliosis is achieved by two independent operators for both methods.
Patients then have a follow-up visit at 6 and 12 months.
- Conditions
- Scoliosis
- Being tested
- Use of Biomod device
- Keywords
- topography, cobb angle
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Biomod deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L.
'Use of Biomod device' for all the patient in addition to the conventional X-ray examination. Receives: Device: Use of Biomod device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.
Number of participants with the same cobb angle measured by surface topography and measured by x-ray.
Measured: up to 1 year
Secondary outcomes (3)
Reproducibility within the operator of measurement of the angle by surface topography
up to 1 year
Measured: At each visit two successive measurements are made by the operator for the same patient. up to 1 year
Reproducibility between the operator of measurement of the angle by surface topography
Two independent operators will measures.
Measured: up to 1 year
The sensitivity of the topography on the detection of the deterioration of the Cobb angle
The sensitivity of the surface topography to detect a worsening of one year more than 5 ° C over the Cobb angle will be assessed compared to the radiograph. It will be obtained by the ratio between the number of aggravations detected by the surface topography and the total number of exacerbations diagnosed by radiography.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme SALES DE GAUZY, Principal investigator, UH Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531945
- Sponsor's protocol ID
- RC31/14/7419
- Acronym
- SCOBIOMOD
- Status last verified
- May 2018
- First submitted
- 18 Aug 2015
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bolzinger M, Bernardini I, Thevenin Lemoine C, Gallini A, Accadbled F, Sales de Gauzy J. Monitoring adolescent idiopathic scoliosis by measuring ribs prominence using surface topography device. Spine Deform. 2021 Sep;9(5):1349-1354. doi: 10.1007/s43390-021-00327-1. Epub 2021 Mar 29.
PubMed 33782905
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography
- ClinicalTrials.gov ID
- NCT02531945
- Acronym / sponsor ID
- SCOBIOMOD / RC31/14/7419
- Conditions
- Scoliosis
- Keywords
- topography, cobb angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 25 Aug 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 main objective of the study is to investigate the correlation between the measurement of the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface topography.
The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L.
Detailed description
For usual follow-up visit, patients will have a x-ray examination of the spine and the surface topography. The measurement of the angle of scoliosis is achieved by two independent operators for both methods.
Patients then have a follow-up visit at 6 and 12 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Use of Biomod deviceThe device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L. 'Use of Biomod device' for all the patient in addition to the conventional X-ray examination. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient with idiopathic scoliosis,
- Body mass index BMI below or equal to 25,
- Cobb angle measured on radiographs between 10 and 25 degrees,
- Parental authorization.
Key exclusion criteria (1 listed)
- Patient with secondary scoliosis (neurological, Prader Willi syndrome...)
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 |
|---|---|---|
| Use of Biomod device | Device | Intervention |
Primary outcome
Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.
Time frame: up to 1 year
Number of participants with the same cobb angle measured by surface topography and measured by x-ray.
3 secondary outcomes
Reproducibility within the operator of measurement of the angle by surface topography
Time frame: At each visit two successive measurements are made by the operator for the same patient. up to 1 year
Reproducibility between the operator of measurement of the angle by surface topography
Time frame: up to 1 year
The sensitivity of the topography on the detection of the deterioration of the Cobb angle
Time frame: up to 1 year
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 Dec 2025.
- Results publication: PubMed 33782905Bolzinger M, Bernardini I, Thevenin Lemoine C, Gallini A, Accadbled F, Sales de Gauzy J. Monitoring adolescent idiopathic scoliosis by measuring ribs prominence using surface topography device. Spine Deform. 2021 Sep;9(5):1349-1354. doi: 10.1007/s43390-021-00327-1. Epub 2021 Mar 29.
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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.
Jérôme SALES DE GAUZY principal investigator
UH Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Biomod device in people with Scoliosis, run by University Hospital, Toulouse 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 4 inclusion and 1 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 Dec 2025. 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?
Correlation between the measurement of Cobb angle by conventional .radiography and surface topography. (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531945, which also lists 1 linked publication.
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 Dec 2025.